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.

14-17 November 2023
Where:  Vienna House Diplomat Hotel, Prague, Czech  Republic

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

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:

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. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

  • 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 
  • 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 


You can view and download the current programme  here.


All courses are taught by experts with real-life practical knowledge and experience. Presenters have included experts from Medicines Evaluation Board (MEB), The State Institute for Drug Control (SUKL), Novartis Pharma AG, Sapientia Regulatory Services, GlaxoSmithKline, Gilead, Pfizer Pharmaceuticals, eCTDconsultancy, Teva Pharmaceuticals, Jazz Pharmaceuticals, DLRC and Astellas Pharma Europe.

Hans van Bruggen, Celgence

Andrew Modley, Teva

Kora Doorduyn-van der Stoep, MEB

Vicky Abbott, Sapienta Regulatory Services Ltd



    • 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 local rate of of 21%. 



    We have a special rate arranged with the hotel for delegates - please use the link HERE to book.

    Terms and conditions

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

    14/11/2023 - 17/11/2023
    Sign in or create an account to register Registration ends 13/11/2023 12:00 (GMT Standard Time)
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