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
Time: Prague, Czech Republic

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 last year's programme here.


All courses are taught by experts with real-life practical knowledge and experience. Past presenters have included experts fromMedicines Evaluation Board (MEB), Novartis Pharma AG, Sapientia Regulatory Services, Federal Institute for Drugs and Medical Devices (BfArM). GlaxoSmithKline, Pfizer Pharmaceuticals, eCTDconsultancy, AstraZeneca, Teva Pharmaceuticals, Astellas Pharma Europe and The State Institute for Drug Control. This year's presenters will be announced closer to the start of the course.

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



  • 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
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