Autumn Introductory Course TARGET THE HEART of ... - TOPRA

The14th 

Autumn Introductory Course 

TOPRA – The Organisation for Professionals in Regulatory Affairs Reference: IC2/08 

TARGET THE HEART 

of European Regulatory Affairs 

Carefully researched and updated each year by 

practising Regulatory Affairs Professionals 

Attend this course and return 

to your office a more confident 

Regulatory Affairs Professional with 

a clear understanding of: 

• 

• 

• 

• 

• 

European Union Regulatory Institutions 

and how Medicines Legislation is developed 

European routes to obtaining Marketing 

Authorisations 

Data Requirements for Marketing 

Authorisation Applications 

Clinical Trial Approval procedures in the 

European Union 

Maintenance of Marketing Authorisations 

and Life Cycle Management 

Speakers: 

Susanne Becker, spm² - safety projects 

& more GmbH 

Isabelle Bertrand, Pfi zer Ltd. 

Jerry Brown, GlaxoSmithKline 

Silvia Chioato, Pfi zer Ltd. 

Belinda Cole, GlaxoSmithKline 

Ronald de Meijer, Astellas Pharma Europe B.V. 

Rui Dos Santos Ivo, Apifarma 

Matthias Finkler, Finkler GmbH 

Katie Harrison, Baxter Healthcare Ltd. 

Steve Harston, Lichtwer Healthcare GmbH & Co. KG 

Feddo Hillen, Remedium Regulatory Affairs 

Stefan Hirsch, Novartis Pharma AG 

Jonathan Hughes, Convatec Ltd 

Vicky Jones, Takeda Global R&D 

Ute Junghanns, EUDRAC GmbH 

Marion Kreitz, Bencard Allergie GmbH 

Sandra Kruger-Peters, Medicines Evaluation Board in 

The Netherlands 

Anne Lenihan, Pfi zer Ltd. 

Carole Murcott, Novartis Pharma AG 

Marie-Helene Pinheiro, EMEA 

Patrick Salmon, Irish Medicines Board 

Alistair Stuart,Takeda Global R&D 

Jason Thwaites, Averion International Ltd 

Lynda Troy, AstraZeneca 

Hans van Bruggen, eCTD Consultancy 

Lynda Wight, TOPRA 

Andrew Willis, Catalent Pharma Solutions 

For more information on this interactive workshop or any other workshop/meeting, or to book, please contact 

the TOPRA office via email or telephone. Further information is also available on the TOPRA website. 

email: meetings@topra.org tel: +44 (0) 20 7538 9502 web: www.topra.org 

Five-Day 

Residential 

Course 

Date: 

Sunday 2nd November 

to Thursday 6th 

November 2008 

Venue: 

Andels Hotel, Prague, 

Czech Republic 

Information: 

Please see back cover 

for important course 

information. 

Lifelong learning 

(LLL): 

This course contributes 29 

hours of training to your LLL 

(sometimes known as Continuing 

Professional Development) and 

will enhance your Regulatory 

Skills relevant in the areas of 

human and veterinary medicines

The14th 


This course offers an excellent 

foundation in Regulatory 

Affairs, reflecting the current 

developments in European 

Legislation and best practice. 

Speakers Overview 

The course is presented by over 30 

speakers and facilitators, all respected 

authorities in their field. 

Speakers are from the different players 

in the Regulatory Affairs business: Health 

Authorities, EMEA and National Regulatory 

Authorities), Pharmaceutical Companies and 

Contract Houses. 

The well balanced set of speakers introduces 

delegates to all aspects of the Regulatory 

Affairs spectrum and provides a unique 

opportunity to interact with these leading 

European professionals. 

Case Studies Overview 

Each programme day includes a case study. 

These accurately tailored case studies enable 

delegates to turn theory into practice. In 

small teams you will be able to focus on 

subjects such as chemical pharmaceutical 

development, clinical development, choice of 

regulatory procedure and variations. 

In addition, facilitators are available to assist. 

The objectives of each part of the course are 

achieved by use of lectures, interaction with 

the lecturers and case studies. 

“Very positive and friendly approach, I enjoyed it immensely.” 

Sunday 2nd November 2008 

15.00pm – 19.30pm 

Welcome and Opening Address 


How does Regulatory Affairs fi t into the picture 

Silvia Chioato, Pfizer Ltd. 

• The importance of Regulatory Affairs 

• Where does Regulatory Affairs fit into the ‘normal’ structure of a 

pharmaceutical company 

• The role of a Regulatory Affairs Professional 

• A future in Regulatory Affairs 

• Future of the Pharmaceutical Industry 

Development of Pharmaceutical Legislation 

Rui Dos Santos Ivo, Apifarma 

• The development of regulations, directives and guidelines 

• Working parties 

• Opportunities to influence legislation 

• New Legislation 

• Brief overview of websites and/or addresses 

• Background to the EU and its Institutions 

Common Technical Document Module 1: 

Administrative Information & Prescribing Information 

Alistair Stuart,Takeda Global R&D 

• Introduction to CTD 

• Overview of Module 1 

• Type of application (including abridged applications) 

• Summary of Product Characteristics (SmPC) 

• EU regional requirements 

Case Study 1 – Ice breaker 

Marion Kreitz, Bencard Allergie GmbH

Monday 3rd November 2008 

09.00am – 17.15pm 

Quality data and Non-clinical data 

Chemical-Pharmaceutical data from a R&D 

perspective 

Stefan Hirsch, Novartis Pharma AG 

• Importance of pharmaceutical development 

• Clinical trial formulation 

• Dosage forms and development 

• Development: pitfalls and solutions 

• Good Manufacturing Practice 


Quality Data from a dossier perspective 


• Build up of Module 3 

• Drug Master File and its implications 

• Drug Product: Excipients and their choice 

• Stability requirements 

• Quality Overall Summary: a dossier entrance 

Non-Clinical (Safety) Data from a R&D perspective 


• Value of pre-clinical work 

• What is necessary for the first trial in man? 

• Further pre-clinical data for the MAA 


Non-Clinical (Safety) Data 


• Pharmacodynamics 

• Pharmacokinetics 

• Environmental risk assessment 

Introduction to Case study 2 

Feddo Hillen, Remedium Reg Affairs 

Case Study 2 – Chemistry and Pharmacy 

Feddo Hillen, Remedium Reg Affairs 


Book 

Early 

Places limited 

Tuesday 4th November 2008 

09.00am to 18.15pm 

Clinical data 

Clinical (Effi cacy) Data from a R&D perspective 


• Overview of clinical development 

• Phase I, II, III trials 

• Paediatric Clinical Trials 

• Setting up a study 

Clinical Trial Authorisations 

Anne Lenihan, Pfizer Ltd. Jason Thwaites, Averion International Ltd 

• Clinical Trial Directive 2001/20/EC 

• Clinical Trial Application Requirements 

• Substantial/Non-substantial Amendments 

• End of Trial Notification 

• Pharmacovigilance for Investigational Medicinal Products 

• Methodology Studies 

• Role of a Regulatory Professional 

Clinical Trial Authorisations, continued 



Clinical (Effi cacy) Data 


• Clinical pharmacology data (PD & PK) 

• Clinical efficacy and safety data 

• Risk benefit analysis 

• The link to the SPC 

Pharmacovigilance and Risk Management 

Susanne Becker, spm² - safety projects & more GmbH 

• Legal requirements 

• Definitions and conventions 

• Good drug safety labelling practice 

• Regulatory action with regards to drug safety 

• Electronic submissions 

• Safety Risk Management and why 

• Risk Management – regulatory status, programmes, examples 

and its value 


Overviews and Overall Summaries 

Patrick Salmon, Irish Medicines Board Alternate delegate CHMP 

• Structure and purpose of Module 2 

• Content and presentation of quality, non-clinical and clinical 

overviews and summaries 

• Consistency and links between documents 

Introduction to Case Study 3 


Case Study 3 – Clinical Trial Case Study 

Anne Lenihan, Pfizer Ltd. Jason Thwaites, Averion International Ltd

Wednesday 5 November 2008 

08.45am to 17.45pm 

European Routes to Obtaining Marketing Authorisations 

The Role and Structure of EMEA 

An introduction to the Centralised Procedure: the Theory 

Marie-Helene Pinheiro, EMEA 

• EMEA, its role, responsibilities and structure 

• EMEA and relationships with national agencies 

• Electronic links between the agencies 

• An overview of the Centralised Procedure 

An Introduction to the Centralised Procedure: 

the Practice 

Belinda Cole, GlaxoSmithKline 

• An overview 

• Interactions with the rapporteur and co-rapporteur 

• How to manage the procedure: internally and externally 

• Practical experience to date 

• Implications of using the procedure – public assessment 

reports & binding decisions 

The Mutual Recognition Procedure & the 

Decentralised Procedure: the Theory 

Sandra Kruger-Peters, Medicines Evaluation Board in The Netherlands Dutch 

member of the Co-ordination Group for MRP and DP 

• A short overview 

• Choice of first country 

• How to manage the procedures including arbitration 

• The new Decentralised procedure 

• Experience with enlarged EU 

The Mutual Recognition Procedure & the 

Decentralised Procedure: the Practice 

Vicky Jones, Takeda Global R&D 

• Choice of Reference Member State (RMS)/Concerned Member 

States (CMSs) 

• Pre-MRP: national procedure in RMS 

• Critical timepoints during MRP 

• CMS objections and company response 

• Roles of headquarter and affiliates during MRP 

• Outcome and follow-up 

• View on Decentralised Procedure 

e-Submissions 

Hans van Bruggen, eCTD Consultancy 

• Regulatory guidenance leading to eCTD 

• Prerequisites for proper eCTD usage 

• Other e-submission initiatives including PIM 

• E-submission readiness 

Choice of Procedure 


• Options available 

• Points to consider when choosing procedure 

Case Study 4 – Choice of Procedure 


Thursday 6 November 2008 

09.00am to 15.00pm 

Maintenance of Marketing Authorisations 

Variations 


• Procedural aspects 

• Regulation 

• Type IA and Type IB variations 

• Type II variations 

• New application vs variation 

Life cycle management 

Andrew Willis, Catalent Pharma Solutions 

• Life cycle management 

• Life of your product 

• Extending the life of your product 

• Regulatory strategies 

Renewals in the European System: the Practice 

Isabelle Bertrand, Pfizer Ltd. 

• Legal basis, MRP, DP and Centralised 

• Requirements and documents to be provided 

• Timelines for submission and assessment 

• New legislation on renewals 

The Registration of Medical Devices 

Jonathan Hughes, Convatec Ltd. 

• Key differences with Pharmaceuticals 

• What is Europe (EU, EC & EEA)? 

• Directives 

• Key Players: Roles & Responsibilities 

• Availability of devices 

• National issues 

• The future 

Case Study 5 – Variations 

Ronald de Meijer, Astellas Pharma, Europe B.V. 

An Introduction to TOPRA 


• What is TOPRA? 

• Who is involved, areas covered 

• What can TOPRA do for me? 

• Information/regulatory resources, training, coaching etc 

• What can you do for TOPRA? 

Chairperson’s Closing Remarks 


“Great course and very good case studies.”

The14th 


INFORMATION Reference: IC2/08 

TARGET THE HEART of European Regulatory Affairs 

Who should attend? 

This residential course is essential for anyone starting a career in 

Regulatory Affairs whether they are new to the pharmaceutical industry 

or moving from other areas within the pharmaceutical field. This course is 

also suitable for more experienced regulatory professionals who wish to 

update their knowledge of European Regulatory Affairs. 

Key features of the course 

• A winning combination of lectures and interactive case studies that 

afford you the opportunity to put theory into practice 

• An international speaker panel with representatives from industry, 

contract houses and regulatory agencies 

• Residential course providing plenty of time for exchanging knowledge 

and sharing experiences with fellow students and speakers 

• Course folder for you to keep including copies of speaker slides, 

a helpful abbreviations list and details of useful websites 

What is TOPRA? 

Our vision... 

To be the organisation for professionals involved in all aspects of 

international healthcare Regulatory Affairs, which is a leading provider 

of high-quality education, training, information and support services, 

and networking opportunities. 

Our objectives... 

• To educate regulatory professionals to the highest standards of 

professional competence 

• To inform all members in a rapid, accurate and accessible manner, 

of the latest developments in global Regulatory Affairs 

• To provide a forum for networking at local, regional and international 

levels for all professionals, whether they be in companies, agencies, 

or working independently, so that they may share experiences and 

knowledge to the benefit of the whole profession 

• To support members in their professional careers 

• To raise the status of healthcare Regulatory Affairs and its 

contribution to public health throughout industry and the wider 

community including universities and government 

“Empowering and motivating course.” 

General information 

Venue 

Andels Hotel, Prague 

CZ-150 00 Prague 5 

Stroupeþnického 21 

Prague, Czech Republic 

Tel: + 420 296 889 688 

Fax: + 420 296 889 999 

E-mail: info@andelshotel.com 

Accommodation and travel 

The course fee includes all course documentation, 

meals and light refreshments (meals requiring special 

preparation, such as Kosher, may incur additional charges), social events 

and accommodation. Accommodation is booked for arrival on Sunday 

the 2nd through to departure on Thursday the 6th November inclusive 

(this will be booked for you by the course organiser). The fee does not 

include travel to and from the venue, hotel services, telephone calls etc 

or refreshments/beverages not offered as part of a meal or social event. 

For additional accommodation please contact the hotel reservation 

desk directly on +420 296 882 201. 

Directions to the venue will be provided in your confirmation paperwork. 

Course social events 

In order to promote networking, the course includes welcome cocktails 

on the Sunday evening and two further enjoyable social events. 

The social events are included in the course fee and includes 

transport where applicable. 

Enquiries 

Enquiries and changes to delegate information should be made to: 

TOPRA, 7 Heron Quays, Marsh Wall, London E14 4JB, UK 

Tel: +44 (0) 20 7538 9502 

Fax: +44 (0) 20 7515 7836 

E-mail: meetings@topra.org

BOOKING FORM 2008 

The14th Autumn Introductory Course 

Date: Sun 2nd Nov – Thurs 6th Nov 2008 Venue: Andels Hotel, Prague, Czech Republic Reference: IC2/08 

TARGET THE HEART of European Regulatory Affairs 

Ways to book 

Please complete in block capital letters and return this form with payment 

to TOPRA using one of the following methods: 

Post: TOPRA, 7 Heron Quays, Marsh Wall, London E14 4JB, UK 

Fax: +44 (0) 20 7515 7836 

On receipt of your booking form we will confirm your provisional place in 

writing and provide directions to the venue. An invoice will be sent separately. 

To ensure admission, payment must be received prior to the meeting. 

If you have any queries, contact us on: +44 (0) 20 7538 9502 

or meetings@topra.org 

Dr Mr Mrs Ms Other 

Family name 

First name Male Female 

Company name 

Job title 

Telephone 

Fax 

E-mail 

Work Address 

City Postcode 

Country 

Invoice Address 

(If different from 

above address) 

City Postcode 

Country 

Special dietary 

requirements 

Experience in the Subject Area 

Negligible Average Considerable 

Your current role 

Generics CRO European role Global role Local affiliate 

Other 

Experience in Regulatory Affairs Years Months 

Please indicate if in your regulatory experience you have worked in one or more 

of the following areas: 

1) CMC 2) EU clinical trials 3) Variations 4) Medical Technologies 

Terms and conditions (Please note: new TOPRA bank details) 

Payment: Payment may be made in Euro or Sterling by cheque, credit/debit card or 

bank transfer. 

• 

• 

Cheques: must be made payable to TOPRA and drawn on a UK bank. 

Credit/debit card: for payment by credit/debit card please complete the relevant 

details above. Cards accepted: AMEX, Debit MasterCard, Delta, Electron, Maestro, 

MasterCard, Solo, Visa. Cards will be charged in Sterling. 

Bank Transfers: may be made to Lloyds TSB Bank PLC. Please quote the delegate’s 

name and the course reference in the transmission details. The delegate must pay all 

bank charges. 

• Sterling Transfers: Account No: 00340310, Sort Code: 30-00-09, 

IBAN: GB45 LOYD 3000 0900 3403 10, BIC LOYDGB21013 

• Euro Transfers: Account No: 86330987, Sort Code: 30-00-09, 

IBAN: GB19 LOYD 3000 0986 3309 87, BIC LOYDGB21013 

• Your place is secured only upon receipt of full payment. 

Please note: Fee includes accommodation but not travel. Unless stated otherwise the 

official language of all our meetings is English. It may be necessary for reasons beyond the 

control of the organisers to alter the dates, venue, timing and content of the programme 

(including speakers) without prior notice; TOPRA regrets that it cannot accept liability for 

losses incurred by delegates in these circumstances. Meals requiring special preparation 

(such as Kosher) may incur additional costs. 

Discounted fees 

Personnel in full-time education, working in academia (full-time) or working 

for a regulatory body may be entitled to a discount on the below fees. Please 

contact the TOPRA office for details. 

Fees and Payment method 

(incl. accommodation Sun 2nd to Thurs 6th November) 

Members �3,700.00 +CZ VAT(19%) �703.00 = �4,403.00 

Non-Members 

Cheque enclosed Cheque No 

�4,060.00 +CZ VAT(19%) �771.40 = �4,831.40 

Bank transfer Date of transfer / 

Please charge my credit/debit card 

Purchase Order No. 

Credit/Debit card details 

(For cards accepted, see payment section below) 

Visa MasterCard American Express Debit card 

Card No 

Expiry date / 

Security code Visa, MasterCard, Debit cards: the last 3 digits AFTER 

the card number in the signature area of the card. 

Card holder name (as given on card) 

Billing address for card (must be provided if different from the Work Address) 

City Postcode 

Country 

TOPRA will seek authorisation from the card-issuing company before confirming 

any reservation (VAT Registration No.: CZ 681 853 486). 

SIGNATURE 

email: meetings@topra.org tel: +44 (0) 20 7538 9502 fax: +44 (0) 20 7515 7836 web: www.topra.org 

DATE 

Cancellations: All cancellations must be received in writing 21 calendar days before the 

start of the course and will be subject to an administration fee of �200. Payment can be 

in Euro or Sterling. For cancellations after this time, or if the delegate fails to attend the course, 

no refund of fees will be given. Substitutions may be made at any time. TOPRA reserves the 

right to cancel the course at any time without liability. In these circumstances, delegates 

will be offered an alternative date, a credit note or a full refund. 

Data protection: TOPRA is registered under the Data Protection Act 1998. 

Your details will not be passed to other companies. If you would like us to change any 

details or if you do not wish to be sent mailings about our meetings please 

write to TOPRA e-mail address: membership@topra.org 

HAdditional support: Please advise TOPRA, at least one month before the meeting, 

if you have any disability that may require additional support. TOPRA makes no distinction 

in its admission policy with regards to disability. TOPRA will make every reasonable effort 

to supply delegates with services that meet their needs. 

Liability: TOPRA regrets that it cannot accept liability for losses incurred by delegates in the 

event of postponement or other alterations to the meeting, i.e. timing, venue, etc. Normal 

TOPRA terms and conditions apply; please contact the TOPRA office for further details. 

We may occasionally send you promotional or other information about TOPRA’s products and 

services. If you do not wish to receive this information, you can opt out of future 

communications by ticking this box 

We may occasionally send you promotional or product information from organisations and 

companies other than TOPRA. If you do not wish to receive this information, you can opt out 

of future communications by ticking this box 

TOPRA – The Organisation for Professionals in Regulatory Affairs Ltd. Registered in England number 1400379. A Company Limited by Guarantee. TOPRA is the registered trademark of The Organisation for Professionals in Regulatory Affairs Ltd, Registered 

Community Trademark number 003182961. The TOPRA logo is covered by The Community Design registration numbers EU Des Reg number 000055553-0001 and 0002. 

/

Autumn Introductory Course TARGET THE HEART of ... - TOPRA

Create successful ePaper yourself

Delete template?

Save as template?