When: 6-9 November 2018
Where: Vienna House Andel’s Prague, Stroupeznickeho 21, 15000 Prague, Czech Republic
Start time (First day): 08:00
End time (Last day): 15:15
TOPRA's Introductory Courses have been designed to provide a firm foundation to your career in regulatory affairs. It is the most comprehensive of its kind and is presented by speakers and facilitators from industry and agencies, all respected authorities in their field.
Our four-day Autumn Introductory Course covers all aspects of the product development process and provides a sound overview of EU legislation and regulatory procedures, plus explores the central role regulatory affairs plays in modern healthcare companies and the development cycle of new drugs. This course is essential for:
- People new to regulatory affairs who want to acquire a strong foundation
- Regulatory professionals wishing to update their knowledge
- Allied professionals wishing to understand the role of regulatory affairs
Note: This course is also Module 0 of the MSc Regulatory Affairs.
Benefits for delegates
CPD: This course provides 30 CPD hours upon successful completion
- Four interactive days with comprehensive range of topics and case studies
- Develop a network to support the rest of your career
- Meet and learn from an international speaker panel from agencies, industry and contract houses
- High quality course materials
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Hans van Bruggen, Senior Regulatory Affairs Scientist at Qdossier/eCTDconsultancy
- Kora Doorduyn-van der Stoep, Senior Policy Adviser, Medicines Evaluation Board (Netherlands)
- Matthias Finkler, Regulatory Affairs Expert, Finkler GmbH
- Steve Harston, Principal at Steve Harston Regulatory Affairs
- Stefan Hirsch, Novartis Pharma AG
- Vicky Jones, Director at Sapientia Regulatory Services
- Birka Lehman, former Head of Executive Department, EU and International Affairs, at Federal Institute for Drugs and Medical Devices (BfArM) – Germany
- Sandrine Lemaire, GlaxoSmithKline
- Ann Lenihan, Director of Regulatory Affairs at Pfizer Pharmaceuticals
- Marjolign van Lier, Regulatory Affairs Scientist at eCTDconsultancy
- Ian Martin, European Regulatory Affairs Director, AstraZeneca
- Arthur Merlin d'Estreux, Associate Director, GRA Respiratory and Oncology, Teva Pharmaceuticals
- Ronald de Meijer, Director of Regulatory Affairs at Astellas Pharma Europe
- Claire Onody, Global Regulatory Lead, UCB
- Bimal Patel, Freelance Regulatory Consultant
- Azzurra Ravizza, Director of Worldwide Regulatory Strategy at Pfizer
- Ann Scott, Director at OA Regulatory
- Elizabeth Soames, Nonclinical Regulatory Project Manager at GlaxoSmithKline
- Lynda Troy, independent regulatory affairs director and former Global Regulatory Lead at AstraZeneca
- Andrew Willis, Principal at A. Willis Consulting and forma Regulatory Affairs Specialist at Extab Corporation
- Tomas Radimersky, Head of Preclinical and Clinical Documentation Assessment Dpt., State Institute for Drug Control
Download the course programme
A limited number of discounted places are available at the rates below.
Please email us at firstname.lastname@example.org for a discount code before making your booking.
|Those working for regulatory agencies, government agencies or academic institutions
|Those working for charities, patient groups or are in full-time education
- VAT, if applicable, is charged at Prague VAT rate of 21%
- The registration fee does not include accommodation
- Refreshments, lunch for four days and three evening meals are included in the registration fee
Course: Essentials of European Pharmaceutical Regulatory Affairs, 22 November, London
Online course: Basics of European Regulatory Affairs
On-demand webinar: Your Career in Regulatory Affairs - Your First Steps
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