The Autumn Introductory Course (Pharmaceuticals)

The Autumn Introductory Course (Pharmaceuticals)
Module 0 of the MSc: This course covers all aspects of the product development process, and provides a sound overview of EU legislation and regulatory procedures, including the central role regulatory affairs plays in modern healthcare companies.

15-18 November 2022
Location: Vienna House Diplomat Prague, Evropská 15, Prague, 16041, Czech Republic 

Please contact if you are interested in booking this course

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 broaden or update their knowledge 
  • Allied professionals moving into 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 
  • Gain the practical skills to be a highly effective regulatory professional 
  • Industry-wide recognised programme will be an excellent start to your career 
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.  


Download a copy of the course programme here.


Andrew Modley, TEVA
Ann Scott, OA Regulatory Limited
Arthur Merlin d’Estreux, Jazz Pharmaceuticals 
Azzurra Ravizza, Pfizer
Elizabeth Soames, DLRC Ltd.
Hans van Bruggen, Qdossier
Iva Gottsteinová, State Institute for Drug Control
Jan Ohotski, Medpace
Karina Griffiths, Pfizer
Kora Doorduyn-van der Stoep, Medicines Evaluation Board 
Marion Kreitz, Bencard Allergie GmbH
Marloes van der Geer, Qdossier
Natalie Schmidt, Pfizer 
Nicholas Sweeney, Jazz Pharmaceuticals
Pauline Gerritsen, Gerritsen Pharmacovigilance Consulting
Ronald de Meijer, Astellas Pharma B.V.
Sandrine Lemaire, GlaxoSmithKline
Stefan Hirsch, Novartis Pharma AG
Vicky Abbott, Sapientia Regulatory Services Ltd

Suitable for

This course is essential for:

  • People new to Regulatory Affairs who want to acquire a comprehensive foundation
  • Regulatory professionals wishing to update their knowledge
  • Allied professionals wanting to understand the role of Regulatory Affairs


A limited number of rooms have been secured at a preferential rate at the Vienna House Diplomat Prague, where the course will be taking place. This offer expires on 27 September 2022. For more information, please email



  • Member: £2,690+VAT*
  • Non-member: £3,010+VAT*

Discounted places

A limited number of discounted places are available at the rates below. Please email us at for a discount code before making your booking.

  • Those working for regulatory agencies, government agencies or academic institutions:
    • Members: £2,017.50+VAT
    • Non-members:  £2,257.50+VAT
  • Those working for charities, patient groups or in full-time education:
    • Members: £1,345+VAT
    • Non-members: £1,505+VAT

*VAT, if applicable, is charged at the rate of 21%. 

Terms and conditions

Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.

15/11/2022 - 18/11/2022
Vienna House Diplomat Prague Evropská 15 PRAGUE CZECH REPUBLIC
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