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
Course information
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
- 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
CPD: This course provides 30 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Presenters
-
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
Programme
Download the course programme
Pricing
Course fees:
| Type |
Member |
Non-member |
| Standard |
£2,690+VAT |
£3,010+VAT |
Discounted places
A limited number of discounted places are available at the rates below.
Please email us at meetings@topra.org for a discount code before making your booking.
|
Those working for regulatory agencies, government agencies or academic institutions
|
£2,017.50+VAT
|
£2,257.50+VAT
|
Those working for charities, patient groups or are in full-time education
|
£1,345+VAT |
£1,505+VAT |
|
- 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
Related courses
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
Next steps
Click here for other upcoming CRED-level courses.
Click here for upcoming webinars
7-29 March 2017, UK
Establishing a firm foundation to your career in regulatory affairs is essential from the outset, and TOPRA is dedicated in playing its part in enabling you to become a regulatory professional with our introductory courses.
The spring edition of our popular three-day course will help you to become a more confident and proactive regulatory affairs professional.
Why should you attend?
- Three interactive days with a comprehensive range of topics and case studies
- Networking opportunities with peers and industry professionals
- An international speaker panel from agencies, industry and contract houses
- High quality course materials
- All inclusive meals
Speakers will include highly respected regulatory professionals from across the industry.
Our introductory course is chosen by regulatory affairs managers for their staff as the most comprehensive course of its kind, reflecting the latest developments in European legislation and best practices.
The course has been completely updated in a three-day format that recognises the time and budgetary restraints of the modern regulatory affairs professional.
Past delegates have gone on to become:
What is included?
- 3 interactive days with a comprehensive range of topics and case studies
- Over 8 hours of networking opportunities
Before booking this course, please read the
training terms and conditions.
By booking a place on this course you are agreeing to the
training terms and conditions.
Registration fees:
Member: £2,295 + VAT
Non Member: £2,675 + VAT
- All fees are shown in Pounds Sterling and include VAT (where applicable) Terms and conditions
- Please note the registration fee excludes accommodation. Further details on how to book accommodation will be sent with the detailed confirmation letter.
- Refreshment breaks, lunch for three days and two evening meals are included in the registration fee.
- Personnel in full-time education, working in academia (full-time) or working for a statutory regulatory body may be entitled to a discount on the above fees. Please contact the TOPRA office for details.
27-29 March 2017, UK
Establishing a firm foundation to your career in regulatory affairs is essential from the outset, and TOPRA is dedicated in playing its part in enabling you to become a regulatory professional with our introductory courses.
The spring edition of our popular three-day course will help you to become a more confident and proactive regulatory affairs professional.
Why should you attend?
- Three interactive days with a comprehensive range of topics and case studies
- Networking opportunities with peers and industry professionals
- An international speaker panel from agencies, industry and contract houses
- High quality course materials
- All inclusive meals
Speakers will include highly respected regulatory professionals from across the industry.
Our introductory course is chosen by regulatory affairs managers for their staff as the most comprehensive course of its kind, reflecting the latest developments in European legislation and best practices.
The course has been completely updated in a three-day format that recognises the time and budgetary restraints of the modern regulatory affairs professional.
Past delegates have gone on to become:
What is included?
- 3 interactive days with a comprehensive range of topics and case studies
- Over 8 hours of networking opportunities
Before booking this course, please read the
training terms and conditions.
By booking a place on this course you are agreeing to the
training terms and conditions.
Registration fees:
Member: £2,295 + VAT
Non Member: £2,675 + VAT
- All fees are shown in Pounds Sterling and include VAT (where applicable) Terms and conditions
- Please note the registration fee excludes accommodation. Further details on how to book accommodation will be sent with the detailed confirmation letter.
- Refreshment breaks, lunch for three days and two evening meals are included in the registration fee.
- Personnel in full-time education, working in academia (full-time) or working for a statutory regulatory body may be entitled to a discount on the above fees. Please contact the TOPRA office for details.
Book now
Simply log in or create an account and register below.