Overview of EU Pharmaceutical Regulatory Affairs

Overview of EU Pharmaceutical Regulatory Affairs
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.

12-15 November 2024
Where: Ramada, Avenida  Engenheiro, Arantes e Oliveria 9, Lisbon, Portugal

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. They are the most comprehensive of their kind and are presented by speakers and facilitators from industry and agencies, all respected authorities in their field.  Our four-day Overview of EU Pharmaceutical Regulatory Affairs course (formerly known as the The Spring 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. 

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 

  • Programme

    You can view and download an example programme based on previous courses here.


    Module Leaders


    Sacha  Lynch, Principal Consultant, DLRC

    Grzegorz Kojro, CDM Manager, Pfizer


    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




    • Member: £2,775 + VAT* 
    • Non-member: £3,165 + VAT*

    Discounted Places

    A limited number of discounted places are available at the rates below for those:

    Please email meetings@topra.org for a discount code before making your booking.

    Discount prices:

    • Those working for regulatory agencies, government agencies or academic institutions:
      • Members: £2,081.25 + VAT*
      • Non-members: £2,373.75 + VAT*
    • Those working for charities, patient groups or in full-time education:
      • Members: £1,387.50 + VAT*
      • Non-members: £1,582.50 + VAT*

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



    If you wish to book accommodation at the hotel please email kay@topra.org for a booking form.

Terms and conditions

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

12/11/2024 - 15/11/2024
Ramada Avenida Engenheiro Arantes E Oliveira Numero 9 LISBON PORTUGAL
Sign in or create an account to register Registration ends 08/11/2024 12:00 (GMT Standard Time)
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