Download Conference Brochure - EMWA
Download Conference Brochure - EMWA
Download Conference Brochure - EMWA
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
| 1 |<br />
35 <strong>EMWA</strong><br />
th<br />
<strong>Conference</strong><br />
8 – 10 November 2012<br />
Andel’s Hotel, Berlin<br />
Germany
| 2 |<br />
Contents<br />
Sponsors and Exhibitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2<br />
Message from the <strong>EMWA</strong> President and Education Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3<br />
Fees and Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4<br />
<strong>EMWA</strong> Professional Development Programme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5<br />
<strong>Conference</strong> Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7<br />
<strong>Conference</strong> Venue and Accommodation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10<br />
Social Programme and Suggestions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11<br />
<strong>Conference</strong> Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12<br />
Leaders’ Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25<br />
Future Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31<br />
GOLD SPONSOR<br />
SILVER SPONSOR<br />
EXHIBITORS<br />
www.congree.com<br />
ee<br />
www.congree.com<br />
ee
Message from the<br />
<strong>EMWA</strong> President<br />
and Education Officer<br />
Dear Members<br />
It is a pleasure for us to welcome you to attend the 35th <strong>EMWA</strong> conference in Berlin, Germany, on 8–10 November 2012 .<br />
The 24 workshops in the conference programme offer a wide range of medical writing topics, providing valuable training whatever your<br />
interest, and the opportunity to gain <strong>EMWA</strong> Professional Development Programme credits . As the workshops fill up quickly, we do urge<br />
you to sign up in good time to avoid disappointment!<br />
As usual, the conference not only offers excellent opportunities for learning and networking at breakfast and lunch during the day,<br />
it also offers the Freelance Business Forum on Friday evening, followed by attractive social events, which include a guided tour of the<br />
Museum of Medical History at the famous Charité Hospital with the opportunity to see their extensive collection of specimens, or<br />
alternatively tasting the local beer and German culinary specialties at Brauhaus Lemke in the lively Hackescher Markt area .<br />
For those of you who have not visited Berlin before, we recommend that you stay on for an extra day at the weekend or arrive early<br />
to explore this exciting and fascinating city . Whether you want to visit one of the many world-class museums, take a look around the<br />
German Parliament building, catch up on post-war history at Checkpoint Charlie, or visit the Brandenburg Gate and stroll down past<br />
the shops on Unter den Linden – or just enjoy Berlin’s patented culinary speciality, the ‘Currywurst’ – it really does offer something for<br />
everyone .<br />
We very much look forward to seeing you in Berlin and wish you an enjoyable and successful conference!<br />
Susan Bhatti Jo Whelan<br />
President Education Officer<br />
<strong>Conference</strong> Administration and Contact Details<br />
<strong>EMWA</strong> Head Office<br />
Chester House, 68 Chestergate, Macclesfield, SK11 6DY, UK<br />
Tel: +44 (0) 1625 664 534<br />
Fax: +44 (0) 1625 664 510<br />
Email: emwaconference@emwa .org<br />
| 3 |
| 4 |<br />
Fees and Registration<br />
<strong>Conference</strong> registration is available to members of the European Medical Writers Association (<strong>EMWA</strong>) . Members and new members<br />
can register online via the <strong>EMWA</strong> website (www .emwa .org) . <strong>EMWA</strong> Head Office can be contacted by e-mail (info@emwa .org) or by<br />
telephone (+44 (0) 01625 644 534) for help with membership or conference registration queries .<br />
Registration Fees<br />
Members New Members New Members Key Dates<br />
in Europe outside Europe<br />
Early Registration €190 €327 €348 Before 11 October<br />
Regular Registration €295 €432 €453 11 October - 1 November<br />
Late On-site Registration €400 €537 €558 After 1 November<br />
The registration fee includes the Welcome Lecture and Drinks Reception, Freelance Business Forum, lunches, refreshment breaks and all<br />
conference materials .<br />
Registration fees are payable in advance . Full payment is due by Monday 5 November 2012 . <strong>EMWA</strong> reserves the right to refuse<br />
admission to the conference if payment has not been received and to request payment on-site at the late registration rate .<br />
Workshop Fees<br />
Foundation €150<br />
Advanced €230<br />
Changes to Registration: An administration fee of €20 will be charged for changes to registration e .g . change of workshop choice or<br />
cancellation of a workshop . There is no fee for adding workshops or social events to your registration .<br />
Cancellation of Attendance: A refund, less an administration fee of €100, will be made for written cancellations of attendance<br />
received before Thursday 18 October 2012 . No refunds will be made after this date and FULL payment is due .<br />
Payment Methods: The preferred payment method is on-line by credit or debit card at the time of registration . If this is not possible an<br />
invoice can be requested and payment made by bank transfer .<br />
Registered Accompanying Persons<br />
Accompanying persons who would like to attend the Welcome Lecture and Drinks Reception and join the <strong>EMWA</strong> lunch and coffee<br />
breaks must be registered for the conference by the <strong>EMWA</strong> member they are accompanying . The fee for registered accompanying<br />
persons is €75 .<br />
Social Events<br />
Details and fees for social events are provided in the social events section of the brochure . <strong>EMWA</strong> members and registered and nonregistered<br />
accompanying persons are welcome to attend social events on payment of the event fee .
<strong>EMWA</strong> Professional<br />
Development Programme<br />
The <strong>EMWA</strong> Professional Development Programme (EPDP) provides high-quality training for medical writers through workshops and<br />
homework assignments . The <strong>EMWA</strong> Professional Development Committee approve workshops for inclusion in the EPDP under the<br />
leadership of the <strong>EMWA</strong> Education Officer . By gaining credit for eight workshops, participants can obtain an EPDP certificate, as<br />
described below . This is one of the few opportunities to obtain a qualification in medical writing .<br />
<strong>EMWA</strong> wants to ensure that the medical writing community, employers, and clients regard the EPDP certificate as a valuable<br />
qualification . To achieve this, we strive to ensure a high level of quality both in workshops and workshop leaders . In addition, <strong>EMWA</strong><br />
workshops have both a pre-workshop exercise or recommended pre-reading, and a post-workshop assessment . Attendees must<br />
complete both to gain credit for the workshop . Those not wanting credits are of course welcome to attend, with or without completing<br />
the assignments, and will receive a certificate of attendance .<br />
Registration is limited to four credit workshops (regardless of level) per conference . There is no limit on registration for non-credit<br />
workshops or seminars .<br />
Gaining EPDP credits<br />
To receive credit for an approved workshop, you must:<br />
• <strong>Download</strong> your pre-workshop assignments from the Members’ only area of the <strong>EMWA</strong> website after registering for the conference.<br />
• Complete the pre-workshop assignment (usually up to 2 hours), and submit it to the workshop leader by the deadline given, if<br />
applicable .<br />
• Attend the workshop itself.<br />
• Complete the post-workshop assignment (usually up to 3 hours) to a satisfactory standard, and submit it by the deadline given.<br />
The times required to complete the pre-workshop and post-workshop assignments are a general guide only .<br />
Late registrants: if you register for the conference after the deadline for the pre-workshop assignment, you should submit the<br />
assignment as soon as you can if you wish to obtain credit . Pre-workshop assignments cannot be accepted after the workshop .<br />
Please note: it is no longer necessary to enrol for the EPDP . Instead, an administration fee will be charged for the issuing of certificates .<br />
Members who have previously paid the EPDP enrolment fee will be exempt from this for the 5 years from their date of enrolment .<br />
| 5 |
| 6 |<br />
EPDP certificates<br />
The EPDP is divided into six subject streams: Drug Development, Language and Writing, Medical Communication, Medical Science,<br />
Professional Techniques, and Soft Skills .<br />
There are two levels of certificate: foundation and advanced .<br />
An EPDP Specialised or Multidisciplinary Certificate at foundation level is awarded to members who have gained credits for eight<br />
foundation workshops as follows:<br />
• At least five workshops in a single subject stream to qualify for a specialised certificate in that option.<br />
• Workshops in at least two options but no more than four workshops per option for a multidisciplinary certificate.<br />
Members may obtain more than one specialised Foundation Certificate after completing the appropriate requirements for each<br />
certificate .<br />
An EPDP Certificate at advanced level is awarded to members who obtain credit in any eight advanced workshops . Advanced Certificates<br />
are limited to one per member .<br />
There are no formal prerequisites (e .g . completion of a Foundation Certificate) to attend advanced workshops or gain an Advanced<br />
Certificate . However, there will not be time during advanced workshops to recap the basics of the subject for attendees who do not fit<br />
the profile in the workshop description .<br />
Workshops are available at the <strong>EMWA</strong> conferences only, and the workshops offered at any conference will depend on the availability of<br />
the workshop leaders .<br />
For further details, including the full list of <strong>EMWA</strong> workshops, see the EPDP brochure on the <strong>EMWA</strong> website (www.emwa.org) .<br />
We welcome ideas for new workshops . If you are interested in developing a workshop, please contact the Education Officer, Jo Whelan<br />
(education@emwa.org) .
<strong>Conference</strong> Overview<br />
Thursday 8 November 2012<br />
18:00–19:30 Collect your badge and conference documents from the <strong>EMWA</strong> Information Desk<br />
18:30 Welcome Lecture and Drinks Reception<br />
Friday 9 November 2012<br />
Morning<br />
08:00–08:45 Collect your badge and conference documents from the <strong>EMWA</strong> Information Desk<br />
09:00–12:30<br />
MSA1<br />
09:00–12:00<br />
DDF19<br />
09:00–12:30<br />
DDF26<br />
09:00–12:30<br />
DDF23<br />
09:00–12:30<br />
PTA3c<br />
09:00–12:30<br />
LWF8<br />
09:00–12:00<br />
DDF18<br />
09:00–12:00<br />
DDF7<br />
12:00–13:45 Lunch<br />
Advanced Epidemiology<br />
(Medical Science — ADVANCED)<br />
Rita Wellens (Wellens Clinical Research Consulting)<br />
The EU Clinical Trials Directive<br />
(Drug Development — FOUNDATION)<br />
Susan Bhatti (Premier Research Germany Ltd)<br />
Introduction to Writing for Medical Devices<br />
(Drug Development — FOUNDATION)<br />
Claudia Frumento (ICiMT International Communication in Medicine & Technology)<br />
Drug Safety for Medical Writers Part 2: Laboratory Data<br />
(Drug Development — FOUNDATION)<br />
Wendy Kingdom (Freelance)<br />
Gillian Pritchard (Sylexis Ltd)<br />
Slippery Slopes: Survival Analysis<br />
(Professional Techniques — ADVANCED)<br />
Thomas Schindler PhD (Boehringer Ingelheim)<br />
Sharpen Up Your Writing Skills<br />
(Language and Writing — FOUNDATION)<br />
Jo Whelan (Textpharm Ltd)<br />
Good SOP Practice: Processes and Authoring<br />
(Drug Development — FOUNDATION)<br />
Tracy Farrow (PPD)<br />
Sam Hamilton (Sam Hamilton Medical Writing Services Ltd)<br />
Introduction to Pharmacokinetics<br />
(Drug Development — FOUNDATION)<br />
John Carpenter (Freelance)<br />
| 7 |
| 8 |<br />
<strong>Conference</strong> Overview continued<br />
Afternoon<br />
14:00–17:00<br />
DDF13<br />
14:00–17:30<br />
LWA4<br />
14:00–17:30<br />
DDA16<br />
14:00–17:00<br />
DDF2a<br />
14:00–17:30<br />
MCF8<br />
14:00–17:00<br />
MSF8<br />
14:00–17:30<br />
MCF14<br />
14:00–17:00<br />
MCF6<br />
Basic Concepts of Study Design in Clinical Development<br />
(Drug Development — FOUNDATION)<br />
Rosemary Bischoff (ClinWrite)<br />
Adam Jacobs (Dianthus Medical Ltd)<br />
Beyond Simple Editing<br />
(Language and Writing — ADVANCED)<br />
Barbara Grossman (Hawkeye Medical Limited)<br />
Marian Hodges (National Institute for Health and Clinical Excellence)<br />
Clinical Trial Disclosure for Medical Writers: Results Posting<br />
(Drug Development — ADVANCED)<br />
Tatjana Poplazarova (GlaxoSmithKline Biologicals, Belgium)<br />
Uma Swaminathan (GlaxoSmithKline Biologicals, Belgium)<br />
The Investigator’s <strong>Brochure</strong><br />
(Drug Development — FOUNDATION)<br />
Douglas Fiebig (Trilogy Writing & Consulting)<br />
From Clinical Study Report to Manuscript<br />
(Medical Communication — FOUNDATION)<br />
Helen Baldwin (Scinopsis)<br />
Basics of Oncology and Drug Development<br />
(Medical Science — FOUNDATION)<br />
Sunethra Wimalasundera (Roche Products Ltd)<br />
What Lies Beyond the Text: Citation Issues Affecting Medical Writers<br />
(Medical Communication — FOUNDATION)<br />
Iain Patten (Freelance)<br />
Publication Planning<br />
(Medical Communication — FOUNDATION)<br />
Julia Donnelly (Freelance)<br />
17:45–18:45 Freelance Business Forum<br />
Sam Hamilton (Sam Hamilton Medical Writing Services Ltd)<br />
19:00 See Social Programme pages for activity options<br />
Saturday 10 November 2012<br />
Morning<br />
09:00–12:30<br />
PTA9<br />
09:00–12:30<br />
LWA5<br />
09:00–12:00<br />
DDF25<br />
Analysis of Variance and Regression Analysis<br />
(Professional Techniques — ADVANCED)<br />
Adam Jacobs (Dianthus Medical Ltd)<br />
Master Class: Editing English Texts Written by Non-native Speakers<br />
(Language and Writing — ADVANCED)<br />
Rosemary Bischoff (ClinWrite)<br />
Alistair Reeves (Ascribe Medical Writing and Translation)<br />
Orphan Drugs<br />
(Drug Development — FOUNDATION)<br />
Christiane Breithaupt (Premier Research Germany Ltd)
<strong>Conference</strong> Overview continued<br />
09:00–12:00<br />
PTF1<br />
09:00–12:00<br />
MCF12<br />
09:00–12:30<br />
DDF11a<br />
09:00–12:30<br />
MCF17<br />
09:00–12:30<br />
PTA10<br />
Data Presentation I: Tables and Graphs<br />
(Professional Techniques — FOUNDATION)<br />
Barry Drees (Trilogy Writing & Consulting)<br />
Grant Writing: A Business Opportunity for Medical Writers?<br />
(Medical Communication — FOUNDATION)<br />
Kari Skinningsrud (Limwric as)<br />
Subject Narratives for Clinical Study Reports<br />
(Drug Development — FOUNDATION)<br />
James Visanji (Accovion GmbH)<br />
Using Writing Guidelines for Manuscripts<br />
(Medical Communication — FOUNDATION)<br />
Andrea Rossi (Eli Lilly Italy)<br />
Effective Reporting of Scales, Questionnaires and VAS<br />
(Professional Techniques - ADVANCED)<br />
Thomas Wagner, PhD (Trilogy Writing and Consulting)<br />
09:30–11:30 Introduction to Medical Writing<br />
(Free Seminar)<br />
Helen Baldwin (Scinopsis)<br />
12:00–13:45 Lunch and departure<br />
| 9 |
| 10 |<br />
<strong>Conference</strong> Venue and Accommodation<br />
Andel’s Hotel Berlin<br />
Landsberger Allee 106<br />
10369 Berlin<br />
Germany<br />
Accommodation<br />
<strong>EMWA</strong> has reserved a number of rooms at the Andel’s<br />
Hotel Berlin at the special rate of €129 .00 per room<br />
including VAT, breakfast, use of the spa facilities and<br />
free internet access .<br />
To take advantage of this discounted conference rate,<br />
please contact the hotel directly quoting “<strong>EMWA</strong> 35” .<br />
Telephone: +49 (0) 30 453053 2200<br />
Fax: +49 30 (0) 453053 2299<br />
Email: reservation@andelsberlin .com<br />
www .andelsberlin .com<br />
The conference rate will be available until 26 September, after which the hotel reserves the right to offer rooms subject to availability at<br />
the prevailing rate .<br />
Alternative hotels a walk or short taxi ride away from the conference hotel are given below .<br />
Please note that <strong>EMWA</strong> does not offer a recommendation for the accommodation quality or customer service for the establishments<br />
below .<br />
Grand City Hotel Globus Berlin<br />
Ruschestrasse 45<br />
10367 Berlin<br />
Germany<br />
Telephone: +49 (0) 30 555070<br />
Email: reservation .berlin@grandcityhotels .com<br />
Located approximately 30 minutes walk (2 .4km) or a short taxi ride from the conference hotel, we have negotiated a reduced rate of<br />
€75 bed and breakfast for delegates quoting “<strong>EMWA</strong> <strong>Conference</strong> 2012” .<br />
Hotel New Berlin<br />
Petersburger Strasse 24<br />
10242 Berlin<br />
Germany<br />
Telephone: +49 (0) 30 4202 5699<br />
Email: info@hotel-newberlin .de<br />
Located approximately 12 minutes walk (1km) from the conference venue, we have negotiated a reduced rate of €100 bed and<br />
breakfast for delegates quoting “<strong>EMWA</strong> <strong>Conference</strong> 2012” .
Social Programme and Suggestions<br />
Friday 9 November 2012<br />
Berlin Brauhaus Informal Networking Evening<br />
€50 per person including drinks, buffet and public<br />
transport tickets to and from venue<br />
Maximum number 120<br />
Guests will travel by tram from the conference hotel to<br />
the renowned Brauhaus Lemke for a networking evening<br />
offering traditional German food, 4 different beers, wines,<br />
soft drinks, and coffee .<br />
Extract from the Brauhaus Lemke website: “Since 1999 the Brauhaus Lemke has been serving up food and its own home-brewed<br />
beer under a listed arch of the viaduct, one of 700 arches making up Berlin’s longest man-made structure . Raw local brickwork, dark<br />
wood and the unconcealed equipment of a working brewery create an atmosphere that perfectly reflects this proud, unadorned urban<br />
feature” .<br />
Private tour of the Charité Medical Museum<br />
€19 per person including a private guided tour of the museum, an hour’s free time<br />
in the museum and public transport tickets to and from venue<br />
Maximum number 25<br />
The Berlin Museum of Medical History is an institution of the Charité –<br />
Universitätsmedizin Berlin and is located in the former museum building of the Pathological Institute on the grounds of the Charité<br />
Hospital .<br />
The museum’s permanent exhibition “On the Trace of Life” provides a path through medical history over the past 300 years . The<br />
presentation follows the ever-changing historical view of and into the body, finally arriving at the ‘recipient’ of medicine, the patient,<br />
and the possibilities inherent in today’s medicine . The heart of the museum is still the specimen hall, the core of which goes back to the<br />
collecting activities of Rudolf Virchow . Today, there are around 750 pathological-anatomical wet and dry preparations on display in this<br />
area .<br />
Eating Out Suggestions<br />
TimeOut Magazine has recently published an article to help you “eat your way across Berlin” . The link below offers an array of<br />
restaurants and cafes to suit all tastes and budgets . Copy and paste the link into your Internet browser to view the article .<br />
http://www .timeout .com/berlin/features/923/berlins-top-30-restaurants<br />
| 11 |
| 12 |<br />
<strong>Conference</strong> Details<br />
Thursday 8 November<br />
18:00–19:30 <strong>Conference</strong> registration open<br />
18:30–20:30 Welcome Lecture and Drinks Reception<br />
Friday 9 November<br />
Advanced Epidemiology (Medical Science — ADVANCED)<br />
MSA1<br />
09:00–12:30<br />
Rita Wellens (Wellens Clinical Research Consulting)<br />
Participant profile<br />
Experienced writers with a basic knowledge of descriptive statistics . Participants are strongly recommended to take the “Basics<br />
of Epidemiology for Medical Communicators” workshop before enrolling in the advanced workshop .<br />
Objective<br />
This workshop is designed for experienced medical writers . The underlying principle is that medical communicators have a<br />
key gatekeeper’s role in ensuring correct interpretation of medical findings . Participants will be provided with advanced data<br />
interpretation insights according to epidemiological concepts . Focus is on the critical appraisal of reported medical findings<br />
and the application of epidemiological tenets to improve their own writing . Commonly used measures of association including<br />
relative risk and odds ratios as well as research designs and causality development will be discussed . Contemporary examples<br />
from clinical medicine, public health and pharmacoepidemiology will be used in class format combining lectures with group<br />
exercises .<br />
The main objectives are:<br />
• Provide advanced data interpretation insights based on epidemiological principles<br />
• Apply a checklist (STROBE) useful for the critical appraisal of medical communications and for improving medical writing skills<br />
Workshop content (3:30 hours)<br />
Three major topics will be covered:<br />
• Basic measures of association<br />
• Overview of ‘good’ research design characteristics and common research designs used in epidemiology - pros and cons<br />
• Association and causation - making sense of a confounding couple<br />
Pre-workshop assignment 3:00 hours<br />
Post-workshop assignment 1:00 hour<br />
The EU Clinical Trials Directive (Drug Development — FOUNDATION)<br />
DDF19<br />
09:00–12:00<br />
Susan Bhatti (Premier Research Germany Ltd)<br />
Participant profile<br />
Medical writers who want to know more about the regulations governing clinical trials in the EU and the role of the institutions<br />
that assess and approve clinical trial applications .<br />
Objective<br />
To provide an introduction to the EU Clinical Trials Directive (Dir . 2001/20 EC), and explain the requirements for the submission<br />
and maintenance of clinical trial applications in the EU .<br />
Workshop content (3:00 hours)<br />
The workshop will explain:<br />
• The requirements of the Clinical Trials Directive and the content of clinical trial applications and the IMPD<br />
• The role of the Competent Authorities<br />
• The role of the Ethics Committees<br />
• Substantial amendments to a clinical trial application<br />
• Requirements for safety reporting during a clinical trial<br />
• End of trial notifications and submission of the clinical study report
Workshop participants should be aware that the format is that of a presentation with opportunity provided for questions,<br />
answers and discussion . There will be a short exercise to complete during the workshop . Individual clinical trial documents, such<br />
as study protocols, will not be discussed as these are already covered by other workshops .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 2:00 hours<br />
Introduction to Writing for Medical Devices (Drug Development — FOUNDATION)<br />
DDF26<br />
09:00–12:30<br />
Claudia Frumento (ICiMT International Communication in Medicine and Technology)<br />
Participant profile<br />
Medical writers with experience in medical communications or regulatory writing . Some experience and understanding of the<br />
regulatory requirements for the market approval of medicinal products is preferable .<br />
Objective<br />
To provide an introduction to the field of medical devices and associated document requirements . Areas covered include:<br />
classification of medical devices, basic regulatory issues regarding the approval and marketing of medical devices, recent changes<br />
in regulatory requirements and how these impact the medical writer’s role, as well as some of the most common medical<br />
communication documents .<br />
Workshop content (3:30 hours)<br />
A syringe, a knee prosthesis, a computerised tomography (CT) scanner, an external defibrillator, and a pacemaker are all medical<br />
devices, but they belong to different classes . The ways to obtain market approval and the documentation required for each of<br />
these devices, as well as the related medical communications texts are different .<br />
Focusing on these medical devices, the main elements of the workshop will introduce:<br />
• Classification criteria for medical devices<br />
• Procedures for the market release of a medical device<br />
• Documentation requirements for the market release of a medical device<br />
• Medical Communication texts: special considerations for medical devices<br />
The workshop will include group exercises and discussions as well as evaluations of real documents .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 2:30 hours<br />
Drug Safety for Medical Writers Part 2: Laboratory Data (Drug Development — FOUNDATION)<br />
DDF23<br />
09:00–12:00<br />
Wendy Kingdom (Freelance)<br />
Gillian Pritchard (Sylexis Ltd)<br />
Participant profile<br />
This workshop is intended for medical writers who are involved in writing the safety sections of clinical study reports or related<br />
safety summaries . Note: This workshop is based on the earlier workshop “Drug Safety for Medical Writers” (DDF9) but has been<br />
divided into two parts so that the topics can be covered in more depth .<br />
Objective<br />
This workshop is designed to give medical writers insight into the processes by which laboratory data, vital signs and ECG data<br />
are generated and recorded during clinical trials and the subsequent handling of these data . On completion of the workshop<br />
package, participants should be confident in their approach to writing the laboratory and other safety data sections of<br />
documents relating to clinical trials, particularly clinical study reports .<br />
Workshop content (3:00 hours)<br />
The role of the medical writer in preparing summaries of safety data are to take a large amount of information and to present<br />
the most important points in a useful and understandable format . The challenge for the writer is to identify what is important<br />
and to answer the readers’ questions before they have been asked . The collection of laboratory, vital sign and ECG data on a<br />
| 13 |
| 14 |<br />
drug begins at the clinical trial level . All safety summaries are built upon this starting point . The aim of the workshop is to bring<br />
the data to life so that the writer can present safety data that are interesting to the reader .<br />
It is not necessary for participants to attend both Part 1 and Part 2 of the workshop but the two parts provide a complete picture<br />
of safety data .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 3:00 hours<br />
Slippery Slopes: Survival Analysis (Professional Techniques — ADVANCED)<br />
PTA3c<br />
09:00–12:30<br />
Thomas Schindler PhD (Boehringer Ingelheim)<br />
Participant profile<br />
The workshop is for everybody who has come into contact with the statistical technique of Kaplan-Meier survival analysis and<br />
who want to know more about what it means . Ideally you should have encountered such analyses in the context of clinical trials .<br />
Some minimal statistical understanding is needed and terms like ‘median’, ‘mean’, ‘confidence interval’, ‘risk’ , and ‘p-value’<br />
should not terrify you .<br />
Objective<br />
The objective is to acquire a basic understanding of Kaplan-Meier analyses and to be able to interpret the resulting graphs .<br />
Workshop content (3:30 hours)<br />
The workshop will give the participant an understanding of the analysis of survival in the context of clinical trials . We will learn<br />
the basics of creating and interpreting Kaplan-Meier graphs and the different elements of reporting Kaplan-Meier analyses .<br />
The appropriate graphical and tabular presentation of these analyses will be discussed, but always the focus will be on the<br />
interpretation . There will be a few group exercises during the course .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 2:00 hours<br />
Sharpen Up Your Writing Skills (Language and writing — FOUNDATION)<br />
LWF8<br />
09:00–12:30<br />
Jo Whelan (Textpharm Ltd)<br />
Participant profile<br />
This workshop will be useful for anyone who wants to make their writing more effective . It will be particularly useful for those<br />
who have come into medical writing without receiving any training in writing skills .<br />
Objective<br />
The objective of the course is to help participants write clear, professional text that communicates effectively with their target<br />
audience . We will focus on writing for STM (scientific/technical/medical) audiences and for patients and the general public, but<br />
the skills taught are applicable to all types of written communication .<br />
Workshop content (3:30 hours)<br />
If we do not persuade our audience to start and then continue reading, our effort as writers is wasted . It is also wasted if readers<br />
fail to understand the intended message, or if we lose credibility through poor presentation . The workshop looks at the principles<br />
of effective writing, and how to use them to achieve your communication goals . Topics covered include:<br />
• Structure and style: the do’s and don’ts of effective writing<br />
• Achieving clarity without ‘dumbing down’<br />
• Common style traps in STM writing<br />
• Writing for patients and the public<br />
• Writing to persuade: make your writing powerful<br />
• Say it concisely: tips for reducing word count<br />
The course contains interactive class exercises, and learning points are illustrated using real examples of good and bad medical<br />
writing .<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 1:00 hour
Good SOP Practice: Processes and Authoring (Drug Development — FOUNDATION)<br />
DDF18<br />
09:00–12:30<br />
Tracy Farrow (PPD)<br />
Sam Hamilton (Sam Hamilton Medical Writing Services Ltd)<br />
Participant profile<br />
Medical writers working in clinical research organisations or the pharmaceutical company environment, as either employees<br />
or as freelancers . The workshop will meet the needs of writers following, reviewing and revising existing Standard Operating<br />
Procedures (SOPs), or creating new SOPs . This is an ideal forum for writers whose organisations or clients have scope to improve<br />
their SOPs .<br />
Objective<br />
• To view SOPs from several perspectives and use this valuable multi-dimensional view in SOP development<br />
• To link process to writing and reviewing from the outset<br />
• To discuss good (and poor) SOP practices in detail<br />
• To put theory into practice using in-workshop exercises<br />
• To place SOPs in the current context by considering their place and management in the electronic environment<br />
• To understand how to create and maintain good SOPs or review existing SOPs<br />
Workshop content (3:30 hours)<br />
• What is an SOP?<br />
• Why do we need SOPs?<br />
• Using, reviewing and creating SOPs: A multi-dimensional perspective<br />
• SOP components<br />
• Planning the SOP<br />
• Language and authoring tips<br />
• SOPs in an electronic age<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 2:00 hours<br />
Introduction to Pharmacokinetics (Drug Development — FOUNDATION)<br />
DDF7<br />
09:00–12:00<br />
John Carpenter (Freelance)<br />
Participant profile<br />
This workshop is aimed at medical writers, both new and experienced, who need to understand the basics of pharmacokinetics .<br />
Participants will normally have had little if any previous formal instruction in pharmacokinetics, or may not have understood what<br />
instruction they have received (or may even have received such instruction before they realised they would need it) .<br />
Objective<br />
The objective of this workshop is to demystify pharmacokinetics for those who are terrified of mathematics . On completing the<br />
workshop participants should understand the meanings of some of the key terms and symbols used in pharmacokinetics, have<br />
some understanding of what the different terms tell us about the properties of drugs and be able to write competently about<br />
basic pharmacokinetics .<br />
Workshop content (3:00 hours)<br />
Participants will be given straightforward explanations and derivations of the key pharmacokinetic principles and equations .<br />
These explanations will be largely conceptual rather than mathematical, with worrisome mathematical terms and techniques<br />
explained in simple terms .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 3:00 hours<br />
| 15 |
| 16 |<br />
Basic Concepts of Study Design in Clinical Development (Drug Development — FOUNDATION)<br />
DDF13<br />
14:00–17:00<br />
Rosemary Bischoff (ClinWrite)<br />
Adam Jacobs (Dianthus Medical Ltd)<br />
Participant profile<br />
This beginners’ workshop is aimed at writers with only limited experience of clinical development . This includes those setting out<br />
to write regulatory documents as well as those who already have experience in medical communications or medical publishing<br />
who wish to understand the concepts underlying experimental study design . It would be an advantage if participants are familiar<br />
with the standard sections of a study protocol .<br />
Objective<br />
To raise basic understanding of both study design and study conduct issues and the importance of these for valid and relevant<br />
experiments in studies intended to prove efficacy .<br />
Workshop content (3:00 hours)<br />
This workshop focuses on the theoretical concepts underlying good design and not the process of either protocol or report<br />
generation, nor the wider content of these documents .<br />
The following topics are covered:<br />
• The design characteristics of a confirmatory study of efficacy<br />
• The relationship between the study objective, the study hypotheses, the choice of endpoint and choice of control group<br />
• Factors governing the identification of the study population<br />
• The basis of sample size and its relationship with ‘power’<br />
• Robustness of data based on the example of the full analysis set (also known as ITT) and a per protocol analysis set<br />
• Bias: blinding and randomizing to treatment groups and identifying bias in data<br />
• The relationship between statistical significance, clinical relevance and ‘generalisability’<br />
There will be classroom-format presentations as well as group exercises . The approach is intuitive, not statistical .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 2:00 hours<br />
Beyond Simple Editing (Language and Writing — ADVANCED)<br />
LWA4<br />
14:00–17:30<br />
Barbara Grossman (Hawkeye Medical Ltd)<br />
Marian Hodges (National Institute for Health and Clinical Excellence)<br />
Participant profile<br />
Experienced medical writers or editors who are ready to move into a more senior role . Participants should be competent in<br />
editing for style and formatting and in basic language editing .<br />
Objective<br />
To consider the elements of in-depth editing – that is, editing that involves revising a piece of text to maximise its effectiveness .<br />
Workshop content (3:30 hours)<br />
We will briefly review the elements of editing and then consider how in-depth editing can improve the quality of a document .<br />
Participants will carefully examine a piece of text using questions raised as part of the pre-workshop assignment . We will then<br />
discuss how the text could be revised, and what should be prioritised if working to a deadline . Exercises will focus on 2 parts of<br />
the document and participants will complete the revisions of these as part of the post-workshop assignment . The workshop will<br />
be interactive, with time for the participants to share their experience . The workshop will not cover on-screen editing, although<br />
using Word to support editing may be discussed .<br />
Pre-workshop assignment 1:30 hours<br />
Post-workshop assignment 3:00 hours
Clinical Trial Disclosure for Medical Writers: Results Posting (Drug Development — ADVANCED)<br />
DDA16<br />
14:00–17:30<br />
Tatjana Poplazarova (GlaxoSmithKline Biologicals, Belgium)<br />
Uma Swaminathan (GlaxoSmithKline Biologicals, Belgium)<br />
Participant profile<br />
This workshop is intended for participants directly or indirectly involved in public disclosure of human subject research or those<br />
with little or no background in this area but who are interested in learning the basics . The workshop will serve as an introduction<br />
to the requirements for results disclosure (web disclosure of results information), highlighting the aspects most relevant for<br />
medical writers . Previous experience preparing results registration records for trial registers (e .g . clinicaltrials .gov) is not required .<br />
Objective<br />
Upon completion of the workshop, participants will be able to:<br />
• Understand the basic principles and importance of Public Disclosure of Human Subject Research<br />
• Identify the key stakeholders, relevant regulations and guidelines, and key venues for disclosing results of clinical trial data<br />
(e .g . clinicaltrails .gov, company sponsored registries)<br />
• Distinguish the ‘must haves’ for timely and accurate results disclosure<br />
• Understand the role medical writers can play in preparing high quality results registration records, as well as how trial<br />
disclosure requirements may influence the preparation of other clinical documents .<br />
Workshop content (3:30 hours)<br />
The workshop will begin with a brief overview of the development of trial disclosure requirements globally . The focus will then<br />
turn to regulations and guidelines that concern public disclosure of results and how they impact the work of the medical writer .<br />
Specific topics covered will include:<br />
• Similarities and differences of key regulations pertaining to results registration, (e.g. FDA Amendments, EU Directive, WHO<br />
requirements, National Registries)<br />
• Considerations for preparing results registration records (timing, content, revisions, consistency of information across multiple<br />
registers)<br />
• Implications for other clinical documents<br />
• Challenges and future developments in trial disclosure<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 2:00 hours<br />
The Investigator’s <strong>Brochure</strong> (Drug Development — FOUNDATION)<br />
DDF2a<br />
14:00–17:00<br />
Douglas Fiebig (Trilogy Writing & Consulting)<br />
Participant profile<br />
Medical writers with at least 1 year of experience in the pharmaceutical industry .<br />
Objective<br />
• Learn what the ICH and regulatory guidelines say about the Investigator’s <strong>Brochure</strong> (IB).<br />
• Learn useful tools and advice for the actual writing, compiling, and managing of an IB project.<br />
• Experience the dynamics of team writing and editing as it pertains to an IB.<br />
Workshop content (3:00 hours)<br />
The IB is definitely the poor cousin in the pharmaceutical industry document family, as it rarely gets the resources and time<br />
required to do it properly . It can also be the bane of the freelancer, as “quick update” projects often turn out to involve<br />
excruciating re-formatting and consistency checks . In the first part of the course, participants will learn the “theory” of IB<br />
writing, i .e . what the ICH and regulatory guidelines say, as well as tools to be used in successful IB writing gleaned from the<br />
extensive experience of the workshop leader . In the second part of the course, participants will work in teams to prepare minibrochure<br />
based on actual data and compare their results to those of the other teams .<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 2:00 hours<br />
| 17 |
| 18 |<br />
From Clinical Study Report to Manuscript (Medical Communication — FOUNDATION)<br />
MCF8<br />
14:00–17:30<br />
Helen Baldwin (Scinopsis)<br />
Participant profile<br />
Medical writers who write or expect to write manuscripts based on Clinical Study Reports (CSRs) . Participants ideally should<br />
have already attended the <strong>EMWA</strong> workshops on ‘Writing a Clinical Study Report Using ICH E3’ and ‘Writing a Manuscript for<br />
Publication’, or should have equivalent experience in at least one of these areas of medical writing .<br />
Objective<br />
To acquire effective strategies and techniques to write a manuscript for publication based on a CSR .<br />
Workshop content (3:30 hours)<br />
• Examine differences between CSRs and manuscripts (pre-workshop assignment)<br />
• Prepare a document checklist for writing a manuscript from a CSR<br />
• Discuss timelines and review cycles for manuscript writing<br />
• Determine which sections of a CSR (ICH E3) are relevant for a manuscript<br />
• Establish guidelines for writing a manuscript based on a CSR<br />
• Analyse examples of CSR text and convert to manuscript format (post-workshop assignment)<br />
The workshop leader will act as a facilitator to optimise exchange of experience between participants, as well as providing insight<br />
based on her expertise in this area .<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 2:00 hours<br />
Basics of Oncology and Drug Development (Medical Science — FOUNDATION)<br />
MSF8<br />
14:00–17:00<br />
Sunethra Wimalasundera (Roche Products Ltd)<br />
Participant profile<br />
This workshop is aimed at medical writers who have little or no experience of working in oncology studies . Participants will gain<br />
an understanding of the biology of the disease, current and new treatment options, clinical assessments and the regulatory<br />
requirements used in cancer studies .<br />
Objective<br />
The objective of this workshop is to provide participants with an understanding of the basic biology of cancer, various types of<br />
strategies used to optimise clinical outcome in the development of cancer drugs and the current and future treatment options<br />
available .<br />
Workshop content (3:00 hours)<br />
This workshop will cover: various terminology used in cancer; explain the difference between the different stages of cancer<br />
(localised and metastatic), different types of assessments (for solid tumours and soft tissue), different types of endpoints (survival<br />
analysis, tumour size, performance status, biomarker analysis); current and new treatment strategies (chemotherapy vs targeted<br />
therapies); and the regulatory requirements which can vary depending on the stage of drug development and the type of drug .<br />
Pre-workshop assignment 1:30 hours<br />
Post-workshop assignment 2:00 hours<br />
What Lies Beyond the Text: Citation Issues Affecting Medical Writers (Medical Communication — FOUNDATION)<br />
MCF14<br />
14:00–17:30<br />
Iain Patten (Freelance)<br />
Participant profile<br />
This workshop will be of most benefit to medical writers and editors who help to facilitate the development of articles for<br />
publication .
Objective<br />
After the workshop, participants should have increased their awareness of how medical writing is influenced by explicit and<br />
implicit reference to external material . They will be better equipped to make conscious decisions about how to use citation<br />
effectively and to deal appropriately with related issues such as citation distortion and plagiarism .<br />
Workshop content (3:30 hours)<br />
Previous title: Appropriate and Inappropriate Use of External Information Sources in Medical Writing<br />
A combination of presentation, group discussion, and exercises will be used to highlight key issues affecting how we make<br />
reference to the literature in medical publications . We will explore the ways in which citations influence how a text is understood<br />
and consider how to ensure clarity in the relationship between textual information and the references used to support it . We<br />
will ultimately look at how citation can be used either appropriately or inappropriately and discuss the implications for medical<br />
publications professionals .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 3:00 hours<br />
Publication Planning (Medical Communication — FOUNDATION)<br />
MCF6<br />
14:00–17:00<br />
Julia Donnelly (Freelance)<br />
Participant profile<br />
This workshop is aimed at writers who are interested in publication planning . It is particularly useful for writers who are asked to<br />
make journal and meeting recommendations for manuscripts .<br />
Objective<br />
Strategic publication plans are developed in two sections: the publication strategy and the publication plan . The publication plan<br />
takes details of the clinical trials programme and makes recommendations on publications – including publication types, journals<br />
and meetings, timing and maximisation of publication opportunity . The aim of this workshop is to introduce the concept of<br />
publication planning and to describe the development and tracking of a publication plan .<br />
Workshop content (3:00 hours)<br />
The introductory part of this workshop will describe the differences between message-driven and data-driven publication plans .<br />
Considerations in developing a data-driven plan will be covered in detail including the influence of data availability, journal and<br />
meeting choice and milestone dates . A practical session will demonstrate how to prepare a fundamental, chronological plan, and<br />
finally, the importance of tracking and maintaining the plan will be discussed .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 3:00 hours<br />
Freelance Business Forum<br />
17:45–18:45<br />
Sam Hamilton (Sam Hamilton Medical Writing Services Ltd)<br />
This is an open forum for freelance medical writers . The aim is to share experience of dilemmas and solutions . It is an opportunity<br />
to find out how other freelancers approach the business of medical writing, to pass on any tips you might have for newcomers,<br />
and find out what freelance writers can do for, and expect from, <strong>EMWA</strong> .<br />
| 19 |
| 20 |<br />
Saturday 10 November<br />
Analysis of Variance and Regression Analysis (Professional Techniques — ADVANCED)<br />
PTA9<br />
09:00–12:30<br />
Adam Jacobs (Dianthus Medical Ltd)<br />
Participant profile<br />
Medical writers who wish to understand analysis of variance, linear regression, and other methods for the analysis of normally<br />
distributed continuous data . Participants should be familiar with basic statistical concepts such as P values and confidence<br />
intervals: those who are shaky on such things should take the workshop “Statistical thinking for medical writers” (PTA1) before<br />
this one .<br />
Objective<br />
To understand the methods used for analysing continuous data, to appreciate that analysis of variance and linear regression are<br />
essentially the same analyses but presented in different ways, to understand some of the assumptions underlying the analyses,<br />
and to learn what features of the analyses are the important ones for medical writers to present when describing analyses .<br />
Workshop content (3:30 hours)<br />
The workshop will focus on understanding what the various statistical tests are, why they are done, and how to interpret the<br />
results . This will not be a tutorial in how to do the statistical tests (other than some of the simplest ones), as it is assumed that<br />
participants will generally receive the results of analyses from statisticians and be given the job of interpreting those results .<br />
• Normal distribution<br />
• Dependent and independent variables<br />
• The T-test: the simplest test for analysing normally distributed data<br />
• One-way ANOVA for comparing more than 2 groups<br />
• Simple linear regression<br />
• Multiple linear regression and more complex ANOVA models<br />
• Understanding ANOVA and regression output<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 4:00 hours<br />
Master Class: Editing English Texts Written by Non-native Speakers (Language and Writing — ADVANCED)<br />
LWA5<br />
09:00–12:30<br />
Rosemary Bischoff (ClinWrite)<br />
Alistair Reeves (Ascribe Medical Writing and Translation)<br />
Participant profile<br />
This workshop is intended for all medical writers, both native English speakers and those for whom English is a second language,<br />
who edit the work of authors who are not native speakers of English . The workshop will be of interest to both those who edit<br />
occasionally for colleagues and people who edit extensively .<br />
Objective<br />
Editing the work of others is a common component of medical writing . This activity can be especially challenging if the original<br />
author was not a native speaker of English and problems of poor writing skills are compounded by lack of fluency in the<br />
language . This workshop will give medical writers training and feedback in this sensitive task .<br />
Workshop content (3:30 hours)<br />
This workshop will take the form of a master class, with a maximum of 12 participants . The workshop leaders see themselves<br />
primarily as facilitators and guides in achieving results . That is to say there will be almost no lecture content . Based on examples<br />
provided by the workshop leaders, participants will work together in small groups to improve a text after which feed back will<br />
be provided all together . Depending on availability it is hoped that other experienced editors will join the class as facilitators . At<br />
the end there will be a discussion session on providing feed back to the original author . The emphasis will be on generating texts<br />
that communicate clearly rather than reviewing grammar rules . Due to the nature of a master class, numbers are very restricted,<br />
so please apply early .<br />
Pre-workshop assignment 30 min . It is essential that this is completed .<br />
Post-workshop assignment 2 .5 hours
Orphan Drugs (Drug Development — FOUNDATION)<br />
DDF25<br />
09:00–12:00<br />
Christiane Breithaupt (Premier Research Germany Ltd)<br />
Participant profile<br />
This workshop is intended for medical writers who are interested in drug development or compiling documents for the<br />
application of orphan drug status . This could be medical writers working for pharmaceutical companies which develop drugs<br />
that could qualify for orphan status, medical writers working for consultants, as well as freelancers who might be concerned in<br />
compiling the necessary documentation for sponsors applying for orphan drug status .<br />
Objective<br />
An increasing number of treatments for rare diseases have been developed over the last few years . Companies may apply for<br />
orphan drug status with the EMA and FDA in order to gain access to a number of incentives . Medical writers may be employed<br />
to compile the supporting documentation for the application, including description of the condition and existing treatments and<br />
calculation of prevalence .<br />
Workshop content (3:00 hours)<br />
The workshop will give an overview on the definition of rare diseases and orphan drugs and the history of orphan drug<br />
legislation . The procedure of applying for and maintaining orphan drug status is described . We will discuss the relevant<br />
documentation which needs to be included in the application, sources for obtaining relevant information and where medical<br />
writers may become involved . As protocol assistance and scientific advice are amongst the incentives granted for orphan drugs,<br />
an overview over the procedure will be part of the workshop .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 3:00 hours<br />
Data Presentation I: Tables and Graphs (Professional Techniques — FOUNDATION)<br />
PTF1<br />
09:00–12:00<br />
Barry Drees (Trilogy Writing & Consulting)<br />
Participant profile<br />
Medical writers and editors with 0–4 years of experience<br />
Objective<br />
At the end of the course participants should be able to:<br />
• Compose a table or graph when given data in raw form or in paragraph style<br />
• Recognise the basic parts of a table and a graph and identify the various types of tables and graphs<br />
• Understand the functions of tables and graphs<br />
• Identify the strengths and weaknesses in the design of a given table or graph and be able to modify it accordingly<br />
Workshop content (3:00 hours)<br />
The role of a medical writer is to be able to present data in the clearest and most understandable form possible . The best way<br />
to present and communicate with data, however, is not prose but rather using some form of graphical presentation . This course<br />
will challenge and stimulate the participants’ ability to think clearly about the data they present and write about . Participants will<br />
learn about the basic tools of data presentation, tables and graphs, their types and components, and when and when NOT - to<br />
use them . It will introduce the participants to the fundamental tools of data presentation, tables and graphs in all their myriad<br />
forms and uses . This course is an introduction to data presentation and should be taken before taking “Data Presentation II:<br />
Advanced Data Presentation” .<br />
Pre-workshop assignment 3:00 hours<br />
Post-workshop assignment 3:00 hours<br />
| 21 |
| 22 |<br />
Grant Writing: A Business Opportunity for Medical Writers? (Medical Communication — FOUNDATION)<br />
MCF12<br />
09:00–12:00<br />
Kari Skinningsrud (Limwric as)<br />
Participant profile<br />
Anyone who would like to explore how medical writers can contribute in writing of grant applications and discuss how this<br />
could be an interesting business opportunity .<br />
Objective<br />
The primary objective of the workshop is to gain competence in how to help researchers translate their ideas into strictly defined<br />
quantifiable projects and sell them to different target groups . The largest target audience for grants applications in Europe is the<br />
EU, and a secondary objective is to gain insight into specific EU grant requirements .<br />
Workshop content (3:00 hours)<br />
Requirements for writing of EU applications will be emphasised, and compared with those from other funding providers .<br />
Competition for research funding is increasing, and well-written grant applications can open or close doors for research careers .<br />
Academia could benefit from medical writers’ knowledge of the strict requirements that regulate work in the pharmaceutical<br />
industry, but few know about us and it is not a field we are much involved in . We should be more involved and this workshop<br />
will explain how and why .<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 2:00 hours<br />
Subject Narratives for Clinical Study Reports (Drug Development — FOUNDATION)<br />
DDF11a<br />
09:00–12:30<br />
James Visanji (Accovion GmbH)<br />
Participant profile<br />
This workshop is intended for medical writers who are familiar with the clinical development process but have no or limited<br />
experience in writing subject narratives for clinical study reports .<br />
Objective<br />
Participants will acquire knowledge of the requirements and criteria for writing subject narratives within the framework<br />
of relevant ICH guidelines . They will obtain an understanding of the narrative writing process, including sources of data,<br />
presentation of information, important functional groups contributing to the narratives, and techniques for narrative generation .<br />
This will enable the writer to prepare high-quality narratives and optimise narrative writing activities .<br />
Workshop content (3:30 hours)<br />
The following topics will be discussed during the first part of the workshop:<br />
• Relevant sections of the ICH guidelines, emphasising the purpose of narratives<br />
• Definition of narrative criteria and categories<br />
• Content, including sources of information and data, the role of clinical trial and pharmacovigilance databases, recycling of<br />
information from CIOMS forms<br />
• The narrative writing process, including formats, templates, use of programmed data, coordination with other functional<br />
groups, quality control, tips for handling narratives in large studies<br />
During the second part of the workshop participants will be divided into groups and asked to write a simple narrative based on<br />
tables and listings .<br />
Pre-workshop assignment 2:00 hours<br />
Post-workshop assignment 2:00 hours
Using Writing Guidelines for Manuscripts (Medical Communication — FOUNDATION)<br />
MCF17<br />
09:00–12:30<br />
Andrea Rossi (Eli Lilly Italy)<br />
Participant profile<br />
This workshop is aimed at any scientific writer writing for scientific journals or for congresses .<br />
Objective<br />
The growing availability of guidelines and checklists makes identification and use of the most appropriate guideline for any<br />
specific disclosure more difficult . This workshop will help the writer to identify what is available and understand how to choose<br />
the most appropriate guideline for their purpose .<br />
Workshop content (3:30 hours)<br />
The Consolidated Standards of Reporting Trials (CONSORT) statement, issued in 2001, was the first example of a comprehensive<br />
and structured guideline on how to communicate the results of randomized clinical trials . In addition, different guidelines<br />
and checklists to use for the results of observational, health outcome, quality of life, mixed-method, and many other types of<br />
studies have been published . To complement all of these, pharmaceutical companies have developed Good Publication Practice,<br />
individual editors have developed their own guidelines, and most journals have their own instructions for authors . In this<br />
workshop we will review the main guidelines to identify when and how they can be used by medical writers .<br />
Pre-workshop assignment 1:00 hour<br />
Post-workshop assignment 2:00 hours<br />
Effective Reporting of Scales, Questionnaires and VAS (Professional Techniques – ADVANCED)<br />
PTA10<br />
09:00 – 12:30<br />
Thomas Wagner, PhD (Trilogy Writing & Consulting)<br />
Participant profile<br />
This workshop addresses writers dealing with or interested in areas of clinical research, such as psychiatry, pain, quality of life, or<br />
health outcomes, where ‘soft’ endpoints are often used to assess treatments . Participants should have at least 1 year of medical<br />
writing experience and should ideally already have written a study report or a manuscript based on the results of clinical studies .<br />
Objective<br />
This workshop explains the use of assessments in treatment outcomes that cannot easily be measured objectively . Typical<br />
examples are patient or physician questionnaires and Visual Analogue Scales (VAS) . These are often used in psychiatry, pain<br />
studies, or quality of life research where objective measurements are not possible or difficult . The reporting of these ‘soft<br />
endpoints’ has some pitfalls, often providing a huge amount of data that is difficult to analyse and interpret . Given the growing<br />
importance of psychiatry and quality of life research, scales and questionnaires are becoming more and more important for<br />
medical writers .<br />
Workshop content (3:30 hours)<br />
Why are ‘soft endpoints’ used in clinical research? What are typical examples of questionnaires? How should the measurements<br />
be selected (validation, generic vs . specific measures, acceptance)? How can results be evaluated and interpreted, including<br />
calculation of scores/subscores and frequently used statistical analyses? How can results be communicated effectively without<br />
overwhelming the reader by the sheer amount of data? What needs to be taken into account when interpreting and discussing<br />
the results of questionnaires?<br />
Pre-workshop assignment 1:30 hours<br />
Post-workshop assignment 2:00 hours<br />
| 23 |
| 24 |<br />
Introduction to Medical Writing<br />
09:30–11:30<br />
Helen Baldwin (Scinopsis)<br />
This seminar is provided free-of-charge and is aimed at those considering a career in medical writing . It is open to conference<br />
delegates and members of the general public . It will also be interesting to those who have recently joined the profession who<br />
would like to know more . In addition to a presentation covering all aspects of medical writing, the seminar leader will act as a<br />
facilitator to optimise exchange of experience between participants, as well as providing insight based on her expertise in this<br />
area .<br />
The aim is to provide information on the following:<br />
• Definition of medical writing and its different categories<br />
• Role of the medical writer throughout the life-cycle of a pharmaceutical product<br />
• Explanation of the different types of documents that we write with detailed information on some of the most common, e.g.<br />
clinical study protocols and reports, investigator brochures, CTDs, manuscripts, posters<br />
• Timelines and project management<br />
• Finding a job as a medical writer (qualities and qualifications required), types of companies that employ medical writers,<br />
recruitment process, working as a freelancer<br />
• Training and networking for medical writers<br />
Members of the public who wish to attend the seminar should approach the <strong>EMWA</strong> Staff at the <strong>Conference</strong> Registration Desk<br />
who will issue them with a temporary badge and direct them to the seminar room .
| 25 |<br />
Leaders’ Profiles<br />
Helen Baldwin PhD<br />
Scinopsis<br />
Helen is a pharmacologist with over 25 years of experience in the biomedical field . As a research scientist in academia and the<br />
pharmaceutical industry, she authored 30 publications in scientific journals . She then spent 5 years as project leader of European<br />
clinical trials in a CRO . In 1999 she started working as a freelance medical writer in the South of France . Then in 2006 she set<br />
up Scinopsis, a service company with a small team of medical writers . Her expertise includes writing of CSRs, protocols, CTD<br />
clinical summaries and overviews, manuscripts, and biomedical translations . Helen served on the EPDC from 2006 to 2007 and<br />
held the posts of <strong>EMWA</strong> Vice President from 2007 to 2009 and President from May 2009 to May 2010 .<br />
Susan Bhatti PhD<br />
Premier Research Germany Ltd<br />
Susan has spent over 15 years working in Regulatory Affairs, both in the pharmaceutical industry and in her present position<br />
as Executive Director of European Regulatory Affairs, Pharmacovigilance and Medical Writing for an international CRO .<br />
She can therefore share many years of experience of interacting with European regulatory authorities and is an expert in<br />
European regulatory requirements . She has been responsible for the submission of clinical trial applications and marketing<br />
authorisation applications in many countries in Europe as well as participating in scientific advice meetings with the EMA and<br />
national regulatory authorities . Over the years she has had first hand experience of the increasing complexity of the regulatory<br />
environment that has accompanied the growth of the European Union . Susan was elected as Vice President of <strong>EMWA</strong> in May<br />
2011 and took over as President in May 2012 .<br />
Rosemary Bischoff MS<br />
ClinWrite<br />
Rosie has been in the pharmaceutical industry since 1974, most of that time as a clinical project leader at Schering AG in Berlin<br />
where she was responsible for the design, conduct and reporting of numerous studies . However, she began her career there as a<br />
‘ghost-writer’ and ended it as head of clinical operations for the business unit Therapeutics . In 1998 she started her own medical<br />
writing business, ClinWrite . She also served on the <strong>EMWA</strong> Professional Development Committee (EPDC) for many years .<br />
Christiane Breithaupt PhD, DVM<br />
Premier Research Germany Ltd<br />
Christiane began her career as a veterinary surgeon and worked as a practising vet for several years before joining the CRO<br />
industry as a medical writer . In this role she gained experience in writing, reviewing and editing study protocols and study reports .<br />
From medical writing Christiane moved into the area of Regulatory Affairs and has been responsible for conducting scientific<br />
advice with European regulatory authorities as well as for the submission of clinical trial and marketing authorisation applications<br />
within the EU . This includes preparation of applications for orphan drug designation along with the associated documents .<br />
John Carpenter BSc, PhD<br />
Freelance<br />
John, a pharmacologist, was Lecturer in Pharmacology at Manchester University from 1974–1992, where he studied drugs<br />
and the movement of ova through oviducts, anti-asthma drug models, and the pharmacokinetics of alcohol (never a shortage<br />
of volunteers) . He has written or contributed to several pharmacology textbooks, and acted as an expert witness in court<br />
cases involving alcohol . In 1992 he became a full-time medical writer, initially with Gardiner-Caldwell Communications, then<br />
Medical Team Director at Medical Action Communications and briefly as Medical Director at OCC . Since 2001 he has been a<br />
freelance medical writer, medical communications consultant and trainer . John is a regular contributor to the range of training<br />
courses offered by the Infrared Group in Poland and by Kemic Bioresearch in Canada . Satisfied customers include the Canadian<br />
Government’s medicines regulatory department . He has served on the <strong>EMWA</strong> Executive Committee as Universities Liaison Officer<br />
and was a member of the <strong>EMWA</strong> Professional Development Committee (EPDC) 2005−2010 .
Julia Donnelly PhD, BPharm, MRPharmS<br />
Freelance<br />
Julia runs her own medical communication company (Julia Donnelly Solutions Limited) and works predominantly for the<br />
pharmaceutical industry . Previously she has worked as a medical writer, project leader, editorial director, technical director and<br />
global resource, training and development director in international medical communications . Julia also worked within medical<br />
information and in a hospital pharmacy . She is an experienced medical writer and trainer, has developed over 40 publication<br />
plans and frequently develops the outputs from the plans she manages . Julia served on the <strong>EMWA</strong> Professional Development<br />
Committee (EPDC) 2005-2010 .<br />
Barry Drees PhD, Editor in the Life Sciences<br />
Trilogy Writing & Consulting<br />
Barry Drees was a witness to the start of the genetech madness when he got his PhD in molecular genetics at the University of<br />
California at San Francisco at the time of the founding of Genentech . Life’s sense of irony took him to Germany, however, where<br />
he worked as a medical writer in the pharmaceutical industry for 12 years, setting up a Phase I writing group and leading several<br />
regulatory submission teams, among other activities . Barry is a frequent speaker on medical writing, statistics and other scientific<br />
communication topics for Management Forum Ltd, as well as various pharmaceutical associations . He also speaks on nonscientific<br />
topics such as the introductory presentation on the history of Malta at the 20th <strong>EMWA</strong> conference . He has appeared<br />
on an educational television programme in Germany to discuss the ethics of genetic engineering and German radio to discuss<br />
medical writing as a career . He is the former Editor-in-chief of ‘The Write Stuff’, the Journal of <strong>EMWA</strong>, and is currently a Senior<br />
Partner of Trilogy Writing & Consulting . He served on the <strong>EMWA</strong> Professional Development Committee (EPDC) 2006-2009, with<br />
a focus on Train-the-Trainer events .<br />
Tracy Farrow GIBiol<br />
PPD<br />
Tracy Farrow, currently Associate Director, Medical Writing for PPD, has more than 22 years of Biomedical Science experience .<br />
Prior to this she worked for ClinTec International as Manager, Medical Writing Services, Pfizer as Medical Writing Therapeutic<br />
Area Lead managing multiple medical writing clinical study reports and Quality Manager for Data Management where she<br />
was responsible for internal and external audit management, SOP and best practice development . She lectured in Intermediate<br />
Laboratory Data Management for the Association for Clinical Data Management for a number of years as part of their<br />
professional development program . She attained her 2 .1 (Hons) G .I .Biol in Biochemistry in 1993 after gaining two Higher<br />
National Certificates in Haematology and Chemistry .<br />
Douglas Fiebig PhD<br />
Trilogy Writing & Consulting<br />
After 8 years in academic research (much of the time spent wading in rivers), Douglas was fortunate to chance upon a job advert<br />
that would launch his career in medical writing . It soon became clear to him that, in addition to keeping his feet dry, working<br />
as a medical writer is surely the most enjoyable way to earn a living using his scientific and linguistic skills . He has been involved<br />
in regulatory medical writing since 1996 . Together with two partners, he took the plunge in 2002 and established a specialist<br />
medical writing consultancy . Many years of working on pre- and post-submission writing activities provided the inspiration for his<br />
<strong>EMWA</strong> workshops . Douglas currently serves on the <strong>EMWA</strong> Professional Development Committee (EPDC) .<br />
Claudia Frumento PhD<br />
ICiMT International Communication in Medicine and Technology<br />
Claudia has a PhD in medical information technology . She graduated at the University of Buenos Aires and received a German<br />
scholarship to do her PhD thesis in the University of Heidelberg . She has more than 16 years experience in the field of medical<br />
technology acquired as Product Manager and European Training and Education Manager for international medical technology<br />
corporations: Guidant and Medtronic and has been a lecturer at the University for Applied Sciences Gießen–Friedberg<br />
(International B2B Marketing and Business English for Mechanical and Industrial Engineers) . She speaks three languages fluently<br />
(English, German and Spanish) and has vast experience in international project management such as: product launches, pan–<br />
European training and programs for physicians, multicentre clinical trials and writing for the medical device and pharmaceutical<br />
industries . She is the coordinator of the ICiMT expert team . Claudia is a member of the <strong>EMWA</strong> Professional Development<br />
Committee .<br />
| 26 |
| 27 |<br />
Barbara Grossman BSc<br />
Hawkeye Medical Ltd<br />
As well as a passion for proofreading and quality control, Barbara has more than 20 years’ experience of medical writing and<br />
editing in the pharmaceutical industry . Before starting her own medical writing and consultancy business (Hawkeye Medical<br />
Limited), she built up and managed the medical writing group at Covance, the CRO, working in a wide range of therapeutic<br />
areas . Barbara has hands-on experience preparing a variety of clinical documents, and has managed several large writing<br />
programmes . She has presented or run workshops at educational institutions and organisations such as BARQA, DIA (Europe and<br />
USA), Management Forum and NICE, and led many company-internal training courses . Barbara has been an <strong>EMWA</strong> workshop<br />
leader since 2001, and was a member of the ICR ‘Study Start-up Expert Working Group’ . She is a Fellow of <strong>EMWA</strong>, having been<br />
its Treasurer from 1998 to 2005 . She currently serves on the <strong>EMWA</strong> Professional Development Committee (EPDC) .<br />
Sam Hamilton PhD<br />
Sam Hamilton Medical Writing Services Ltd<br />
Sam is a postdoctoral virologist with a multidisciplinary clinical research background since 1994 . Sam specialised in medical<br />
writing from 1998, writing extensively for regulatory authorities, and most recently managing the UK Medical Writing group for<br />
the 5th largest CRO globally before going freelance in 2006 . In October 2007, Sam co-founded the regular freelance feature<br />
section “Out on Our Own” in Medical Writing, is a regular contributor to the publication and guest-edited the March 2009<br />
edition of TWS on the theme of regulatory writing . Together with her team she runs the Freelance Business Forums at <strong>EMWA</strong><br />
conferences . Sam has been involved in content development for the past four <strong>EMWA</strong> spring conferences and currently sits on<br />
the President’s Sub Committee .<br />
Marian Hodges BSc<br />
National Institute for Health and Clinical Excellence<br />
Marian has more than 20 years’ experience of medical writing and editing . Currently, she is Associate Director (Publishing) in the<br />
Communications team at the National Institute for Health and Clinical Excellence (NICE) . At NICE, she is responsible for a team<br />
who edit and publish documents from all of the NICE work programmes . Marian is enthusiastic about developing members<br />
of the team through training and mentoring, and runs workshops on effective writing for colleagues across the organisation .<br />
Before joining NICE, Marian was a freelance medical writer and editor, working on a wide range of materials for pharmaceutical,<br />
medical communication and publishing companies . Marian set up the <strong>EMWA</strong> website and was the web editor until 2006 . She<br />
has been a workshop leader since 2001 and is a Fellow of <strong>EMWA</strong> . She currently serves on the <strong>EMWA</strong> Professional Development<br />
Committee (EPDC) .<br />
Adam Jacobs MSc, PhD, FICR, CSci, Dip IoD<br />
Dianthus Medical Ltd<br />
After getting bored with his first two careers (organic chemistry research and medical translating), Adam worked as a medical<br />
writer first at a small contract research organisation and then at a large medical communications agency . He set up his own<br />
business (www .dianthus .co .uk) in 1999, and has subsequently taken a part-time MSc course in medical statistics, which he<br />
completed in 2002 . Adam was <strong>EMWA</strong> president in 2004–05, was co-author of <strong>EMWA</strong>’s guidelines on the role of professional<br />
medical writers in publications, and currently holds the role of <strong>EMWA</strong>’s press officer . He is still not bored with medical writing .<br />
Wendy Kingdom PhD, MRPharmS<br />
Freelance<br />
Wendy has 25 years’ experience of clinical research and medical writing in the pharmaceutical industry . She started her career as<br />
a clinical research associate; writing protocols, preparing related study documents, managing studies, and writing clinical study<br />
reports . She has been working as a freelance medical writer since 2002 and focuses on clinical and regulatory documents . She<br />
provides commercial training on medical writing and also gives academic lectures on this subject . Wendy was <strong>EMWA</strong> Education<br />
Officer 2003-2005, served on the <strong>EMWA</strong> Professional Development Committee (EPDC) for 5 years, and was Treasurer of <strong>EMWA</strong><br />
from 2005-2009 .
Iain Patten PhD<br />
Iain Patten is an independent scientific writing and translation consultant based in Valencia, Spain . He trained as a biomedical<br />
scientist in the UK and undertook research in neuroscience and embryology before shifting his attention to scientific<br />
communication . He worked for a number of years in Spain as an editor and translator of biomedical science and later in the UK<br />
in the medical communications industry . He currently offers an integrated writing-support service for scientists and clinicians,<br />
with services ranging from training and scientific consultancy, through translation and editing, to medical and scientific writing .<br />
Tatjana Poplazarova<br />
GlaxoSmithKline Biologicals<br />
Tatjana is currently Head of Medical Governance and Bioethics at GSK Biologicals and leads a team of experts promoting<br />
industry-leading medical governance and bioethical excellence for GSK . Previously, as Director of Scientific and Public Disclosure<br />
at GSKBiologicals, Tatjana headed an international team with representatives in the Asia-Pacific region, Europe and the USA<br />
which was involved in both regulatory submissions (writing of protocols, study reports, clinical study summaries) and disclosure<br />
activities (both web based disclosure and publications) . Tatjana is one of the founders of the disclosure team at GSK Biologicals<br />
and spearheads both strategic and operational aspects related to disclosure of human subject research . Tatjana is also the<br />
Biologicals representative at the GSK decision making body on disclosure activities .<br />
Gillian Pritchard MSc, MRCP, MFPM, MBA<br />
Sylexis Ltd<br />
Gillian is a pharmaceutical physician and medical writer with many years experience of designing, conducting and reporting<br />
clinical trials, from the perspective of an investigator in academia, as a research physician in phase I and II clinical trials and as a<br />
clinical project manager of phase III trials with a global pharmaceutical company . Gillian developed and delivered a GCP training<br />
course for investigators during her time with a pharmaceutical and medical devices consultancy . She established Sylexis Ltd . in<br />
2006 and is involved mainly with regulatory writing and some market assessment projects . In 2009 Gillian was elected as <strong>EMWA</strong><br />
Treasurer .<br />
Alistair Reeves BA (Hons), Editor in the Life Sciences<br />
Ascribe Medical Writing and Translation<br />
Alistair became a freelance writer, editor and trainer in 2002 after 25 years in the pharmaceutical industry in different roles<br />
in market research, clinical research, drug regulatory affairs, medical translation, medical writing, case report form design,<br />
and document management and publishing . He has extensive writing and editing experience in a wide range of clinical areas<br />
including endocrinology, oncology, infectious diseases, cardiovascular medicine, transplant surgery, traumatology and veterinary<br />
and laboratory medicine . Over the past 15 years, he has presented courses on many aspects of medical writing for commercial<br />
training organizations and regularly holds in-house courses for small and large pharmaceutical companies throughout Europe . He<br />
has given workshops at almost all <strong>EMWA</strong> events since 1997, and is an Honorary Fellow of <strong>EMWA</strong> . Alistair is currently serving as<br />
<strong>EMWA</strong> <strong>Conference</strong> Director .<br />
Andrea Rossi<br />
Eli Lilly Italy<br />
Andrea Rossi has a degree in Biology from Florence University . After a brief spell at the University, he started working in the<br />
Italian affiliate of Eli Lilly as a Clinical Research Associate . In the years that followed he was responsible for Statistics, Health<br />
Outcomes and Medical Information . Andrea has been working as Medical Writer since 2003 . He is author of more than 300<br />
disclosures and acknowledged for his contribution in several others . From 2007 to 2009 he was on the coordination board<br />
of BIAS (BiometristiItalianiAssociati) and has been an <strong>EMWA</strong> member since 2004 . Andrea acts as trainer for statistics and<br />
medical writing in some Italian schools with a specialisation in oncology, and has been a speaker at national and international<br />
conferences . Andrea was elected Vice President of <strong>EMWA</strong> in May 2012 .<br />
Thomas Schindler PhD<br />
Boehringer Ingelheim<br />
Thomas has been a medical writer for some 15 years, and has worked in a CRO, as well as in ‘small pharma’ and ‘big(ger)<br />
pharma’ . He always had a liking for language and loved science at the same time . He therefore studied both and added a PhD<br />
in biology to it . After doing postdoctoral research, he went into publishing as a popular science editor and eventually switched<br />
over to medical writing . He has extensive experience in both the marketing and the regulatory side of medical writing including<br />
clinical trial reports and submission documents . Currently he is head of the European medical writing group of Boehringer<br />
Ingelheim, Germany .<br />
| 28 |
| 29 |<br />
Kari Skinningsrud MS (Chem)<br />
Limwric as<br />
Kari became a freelance writer and translator in 2002 after more than 15 years in the pharmaceutical industry in different roles<br />
in product management, clinical research and medical writing . She has extensive writing and editing experience in a wide rage<br />
of clinical areas including oncology, cardiovascular and respiratory medicine, endocrinology, imaging, migraine, ophthalmology,<br />
neurology, transplant surgery and laboratory medicine . Kari has been an English consultant for the Journal of the Norwegian<br />
Medical Association for 5 years and provides training in life science writing to Norwegian researchers and PhD students . She was<br />
<strong>EMWA</strong>’s Public Relations Officer from 2005 to 2009 .<br />
Uma Swaminathan MSc, MBA<br />
GlaxoSmithKline Biologicals<br />
Uma’s passion for medical writing brought her all the way from Bangalore (India) to Belgium . During her Scientific Writing<br />
career of over 7 years at GSK, Uma has worked on a wide range of regulatory and disclosure documents across different vaccine<br />
projects . Her current role as Manager for Clinical Trial Register and Protocol Posting within GSK has allowed her to further<br />
develop her skills in the field of project management and scientific communication . These included such diverse activities as<br />
understanding and complying with the complex and ever-changing legal and regulatory requirements for disclosure; planning,<br />
tracking and delivery of protocol and results summaries; cross-functional training; and increasing the public disclosure awareness<br />
within the company .<br />
James Visanji<br />
Accovion GmbH<br />
Following a PhD in medical sciences at Manchester University, postdoctoral work in oncology in Italy, and a brief stint as a<br />
freelance translator, James joined Accovion in 2006, where he is now senior medical writer and deputy group head of medical<br />
writing . His focus is on clinical and regulatory documentation, in particular study protocols and reports and CTD clinical<br />
summaries and overviews . James has been a member of <strong>EMWA</strong> since 2007, and of the Chartered Institute of Linguists since<br />
2004 .<br />
Thomas Wagner, PhD<br />
Trilogy Writing & Consulting<br />
Thomas is a biologist by training and worked hard to unravel the mysteries of the brain using his own brain and such obscure<br />
things as glass needles, fluorescent dyes and white powders called neurotransmitters . However, in order to avoid going mad<br />
himself, he quit university and started his medical writing career in 1999 with the CRO Kendle in Munich . In 2002 he changed<br />
to big pharma and worked for Lilly Deutschland GmbH, mainly writing on Phase III-IV projects, including observational studies .<br />
Still working in the area of madness, he mostly tackled psychiatry, quality of life, and red tape in the position of Group Leader<br />
Scientific Communications Europe for Neurosciences at Eli Lilly & Co . To avoid getting entangled too much, he then changed<br />
back in 2009 to the other side of the fence as a service provider and consultant now working for Trilogy Writing & Consulting as<br />
a Medical Writing Manager .<br />
Rita Wellens MSc, PhD<br />
Wellens Clinical Research Consulting<br />
Rita has extensive experience with project management, training, and medical writing for pharmaceutical companies and CROs .<br />
She managed epidemiology projects worldwide for GlaxoSmithKline Biologicals for about 8 years . In a previous life, she held<br />
university faculty positions in the USA that included teaching epidemiology and research methods . She authored numerous<br />
publications and received several NIH and AHA grants for research in cardiovascular epidemiology . Rita strongly feels that<br />
medical writers have a key role in the critical appraisal and sound reporting of medical findings . Rita served as <strong>EMWA</strong> Vice-<br />
President and President from 2010 to 2012 .
Jo Whelan BSc<br />
Textpharm Ltd<br />
Jo Whelan is a freelance medical writer with a broad range of experience in medical communications . She is also an occasional<br />
science and health journalist . Her working life is nothing if not varied: she often finds herself writing a scientific paper one week,<br />
text for a website the next, and working on health economics documents the week after . She has also written numerous news<br />
and feature articles for the scientific press, and is author of four health-related books for teenagers . After a degree in biology<br />
Jo worked as an editor in scientific publishing, then as a writer at a medical communications agency, before going freelance<br />
in 1996 . She has a particular interest in oncology and is studying part time for an MSc in Cancer Therapeutics at Barts Cancer<br />
Institute, London . Jo is currently serving as <strong>EMWA</strong>’s Education Officer .<br />
Sunethra Wimalasundera PhD<br />
Roche Products Limited<br />
Sunethra started her career in medical science in pharmacology but soon moved on to immunology and her PhD . at University<br />
College London . Following several years of chopping up human tonsils, she entered the pharmaceutical industry as a Clinical<br />
Research Associate at AstraZeneca . After 18 months of lugging around CRFs and chasing investigators for signatures, she<br />
discovered (to her amazement), the world of medical writing where all she had to do was read and write about science . She<br />
now works at Roche as a clinical scientist in immunology . Sunethra was inspired to give these workshops from her interest in<br />
immunology and oncology .<br />
| 30 |
FUTURE EVENTS<br />
<strong>EMWA</strong> Spring <strong>Conference</strong> 2013<br />
7 – 11 May<br />
Manchester Central Convention Complex,<br />
Manchester, England<br />
<strong>EMWA</strong> Autumn <strong>Conference</strong> 2013<br />
7 – 9 November<br />
Hotel Fira Palace, Barcelona, Spain<br />
Keep in touch with developments on the <strong>EMWA</strong> website,<br />
www .emwa .org<br />
| 31 |
| 32 |<br />
36 <strong>EMWA</strong><br />
th<br />
<strong>Conference</strong><br />
7 – 11 May 2013<br />
Manchester Central Convention Complex, Manchester<br />
England
Change language