Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
Pre-Conference Tutorials, Monday, March 8, 2010, 09:00
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Other Sessions<br />
44<br />
This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.<br />
<strong>Monday</strong>, <strong>March</strong> 08, <strong>2010</strong><br />
<strong>09</strong>:<strong>00</strong> - 10:30 Session 15<strong>00</strong><br />
STUDENT AND YOUNG PROFESSIONAL SESSION 1<br />
TRAINING AND JOB OPPORTUNITIES IN THE WORLD OF THE<br />
PHARMACEUTICAL INDUSTRY<br />
Session Co-Chairs:<br />
Sonja Pumplün, Vice <strong>Pre</strong>sident, Head Global Drug Regulatory Affairs, Actelion<br />
Pharmaceuticals Ltd., Switzerland<br />
Annette Mollet, Head, Training and Education, ECPM European Center of<br />
Pharmaceutical Medicine, University Hospital Basel, Switzerland<br />
Meet and exchange views with different key players in the healthcare system.<br />
Learn about different job profiles, continuing education and training<br />
possibilities to find a job in the pharmaceutical industry. Please join us and take<br />
the opportunity to discuss with experts who are involved in the process.<br />
Finding the Right Job in the Pharmaceutical Industry<br />
Detlef Niese, Head of External Affairs, Novartis Pharma AG, Switzerland<br />
Job Opportunities at the Health Authority<br />
Speaker invited<br />
European Postgraduate Training Platform<br />
Annette Mollet, Head, Training and Education, ECPM European Center of<br />
Pharmaceutical Medicine, University Hospital Basel, Switzerland<br />
11:<strong>00</strong>-12:30 Session 16<strong>00</strong><br />
STUDENT AND YOUNG PROFESSIONAL SESSION 2<br />
HOW TO PRESENT AND SELL YOUR SKILLS<br />
Session Co-Chairs:<br />
Annette Mollet, Head, Training and Education, ECPM European Center of<br />
Pharmaceutical Medicine, University Hospital Basel, Switzerland<br />
Sonja Pumplün, Vice <strong>Pre</strong>sident, Head Global Drug Regulatory Affairs, Actelion<br />
Pharmaceuticals Ltd., Switzerland<br />
Please join us to hear from top specialists on how to brand yourself and best sell<br />
your skills by careful preparation for a job interview. How to improve your style<br />
and language skills to adapt to an international environment. You will have the<br />
opportunity to interact with experts from the healthcare industry.<br />
Brand Yourself<br />
Alex Khatuntsev, Human Resources Director, Actelion Pharmaceuticals Ltd.,<br />
Switzerland<br />
<strong>Pre</strong>sentation Skills in English for Job Interview<br />
Judy Churchill, Director, Language Consulting Services, Ltd., UK<br />
How to Sell Yourself in an Interview<br />
Stephanie Zechner, Clinical Research Scientist, CTC Clinical Trial Consulting AG,<br />
Switzerland<br />
Tuesday, <strong>March</strong> <strong>09</strong>, <strong>2010</strong><br />
Hot Topics/Stand-Alone Sessions<br />
18:<strong>00</strong> Session 17<strong>00</strong><br />
AGENCY SATELLITE SESSION<br />
FOCUS ON SMALL AGENCIES AND SMALL MARKETS<br />
Session Chair<br />
Sif Ormarsdóttir, CHMP, European Medicines Agency, Clinical Assessor,<br />
Medicines Control Agency, Iceland<br />
The particular position and the challenges of small agencies are highlighted in<br />
presentations that address the pros and cons of being small in the current<br />
European regulatory environment. In what ways has the legislation of the<br />
European regulatory system benefited small agencies and how can small<br />
agencies cope with challenges in balancing between constantly growing<br />
national and EU needs? On the other hand, the mandate to contribute to the<br />
network, in particular to the European Medicines Agency activities is another<br />
source of set of challenges. Different solutions to fulfill the functions of an EU<br />
regulatory agency in <strong>2010</strong> are presented. The pharmaceutical industries<br />
experience with small agencies is presented. Drug availability in small markets<br />
is an issue and the role of small agencies and the responsibility of industry to<br />
improve the access of drugs are discussed.<br />
The Pros of Small Agencies<br />
John-Joseph Borg, PDCO, CHMP, European Medicines Agency, Post-Licensing<br />
Director, Medicines Authority, Malta<br />
The Cons of Being Small<br />
Romaldas Maciulaitis, CHMP, European Medicines Agency, State Medicines<br />
Control Agency, Lithuania<br />
The Industry Perspective on Small Agencies and Small Markets<br />
Gudrun Dóra Gísladóttir, Director Regulatory Affairs, Actavis, Iceland<br />
DIA Upcoming Training Courses<br />
Clinical Research<br />
Essentials of Clinical Study Management<br />
May 5-7, <strong>2010</strong> | Vienna, AUSTRIA<br />
November 10-12, <strong>2010</strong> | Lisbon,<br />
PORTUGAL<br />
Clinical Project Management in Europe –<br />
Part I<br />
February 10-12, <strong>2010</strong> | Paris, FRANCE<br />
Clinical Project Management in Europe –<br />
Part II<br />
September 22-24, <strong>2010</strong> | Basel,<br />
SWITZERLAND<br />
Practical GCP Compliance Auditing of<br />
Trials & Systems<br />
October 6-8, <strong>2010</strong> | London,<br />
UNITED KINGDOM<br />
Clinical Statistics for Non-Statisticians<br />
September 13-14, <strong>2010</strong> | Paris, FRANCE<br />
Regulatory Affairs<br />
Comprehensive Training on European<br />
Regulatory Affairs: Expert Overview<br />
January 24-26, <strong>2010</strong> | Dubai,<br />
UNITED ARAB EMIRATES<br />
CTD Dossier Requirements: Focus on EU<br />
Module 1 and Quality Module 3<br />
April 26-28, <strong>2010</strong> | Vienna, AUSTRIA<br />
December 5-7, <strong>2010</strong> | Dubai,<br />
UNITED ARAB EMIRATES<br />
European Regulatory Affairs: Review of<br />
Current Registration Procedures in the EU<br />
February 15-16, <strong>2010</strong> | Lisbon, PORTUGAL<br />
June 3-4, <strong>2010</strong> | Prague, CZECH REPUBLIC<br />
November 18-19, <strong>2010</strong> | Paris, FRANCE<br />
US Regulatory Affairs<br />
October 18-21, <strong>2010</strong> | Prague,<br />
CZECH REPUBLIC<br />
Good Management of Medical Devices<br />
April 26-28, <strong>2010</strong> | Paris, FRANCE<br />
October 27-29, <strong>2010</strong> | Geneva,<br />
SWITZERLAND<br />
Building the eCTD<br />
February 11-12, <strong>2010</strong> | Paris, FRANCE<br />
September 23-24, <strong>2010</strong> | Basel,<br />
SWITZERLAND<br />
An Introduction to Product Information<br />
Management (PIM)<br />
April 26-27, <strong>2010</strong> | Vienna, AUSTRIA<br />
October 28-29, <strong>2010</strong> | Geneva,<br />
SWITZERLAND<br />
Safety and Pharmacovigilance<br />
Excellence in Pharmacovigilance: Clinical<br />
Trials and Post Marketing<br />
February 8-12, <strong>2010</strong> | Paris, FRANCE<br />
October 25-29, <strong>2010</strong> | Vienna, AUSTRIA<br />
Practical Guide for Pharmacovigilance:<br />
Clinical Trials and Post Marketing<br />
June 2-4, <strong>2010</strong> | Prague,<br />
CZECH REPUBLIC<br />
December 1-3, <strong>2010</strong> | Paris, FRANCE<br />
Medical Approach in Diagnosis and<br />
Management of ADRs<br />
September 13-14, <strong>2010</strong> | Paris, FRANCE<br />
Introduction to Signal Detection and<br />
Data Mining in Pharmacovigilance<br />
April 26, <strong>2010</strong> | Paris, FRANCE<br />
October 7, <strong>2010</strong> | London,<br />
UNITED KINGDOM<br />
How to prepare for Pharmacovigilance<br />
Audits and Inspections<br />
April 27, <strong>2010</strong> | Paris, FRANCE<br />
October 8, <strong>2010</strong> | London,<br />
UNITED KINGDOM<br />
EudraVigilance Information Day<br />
June 22, <strong>2010</strong> | European Medicines<br />
Agency, London,<br />
UNITED KINGDOM<br />
October 19, <strong>2010</strong> | European Medicines<br />
Agency, London, UNITED KINGDOM<br />
Non-Clinical Sciences<br />
Non-Clinical Safety Sciences and Their<br />
Regulatory Aspects<br />
June 7-10, <strong>2010</strong> | Location to be confirmed<br />
November 22-25, <strong>2010</strong> | Location to be<br />
confirmed<br />
For more information and a complete listing of all training courses, please visit www.diahome.org<br />
and click on <strong>Conference</strong>s/Meetings or Training.