Introductory Courses in Regulatory Affairs

If you want to build a solid and comprehensive foundation in regulatory affairs, our Introductory Courses are for you. Choose from courses focusing on pharmaceutical or medical devices.

The courses are presented by speakers and facilitators from industry and agencies, all respected authorities in their fields.

Each five-day course (or three-day for the Medical Devices Introductory Course) covers all aspects of the product development process and provides a sound overview of EU legislation and regulatory procedures. We look at the central role regulatory affairs plays in modern healthcare companies and the development cycle of new drugs and devices.

Upcoming courses:






Who are these courses for?

  • People new to regulatory affairs
  • Professionals wishing to update and refresh their knowledge
  • Allied professionals wishing to understand the role of regulatory affairs.

We suggest that you have at least six months’ regulatory experience before attending these courses.


Why should I attend?

The TOPRA Introductory Courses are recognised as the most comprehensive of their kind. The content for each course is up to date and researched by practising regulatory professionals.

These intensive courses provide a unique opportunity to exchange knowledge and experiences with your peers and build a personal network. You will also have access to international experts from industry and regulatory authorities.

You can expect to gain in confidence as a regulatory professional. The course proves your commitment to regulatory affairs and demonstrates that you have the foundation knowledge to progress your career.

This course has been supplied to UK delegates seeking employment via Job Centre Plus, part of the Department for Work and Pensions.


What will I learn?

The courses look at the big picture, covering not only EU legislation and regulatory procedures but also the central role regulatory affairs plays from design and development through to marketing authorisation and post-approval maintenance.


How will I learn?

Lectures are given by experts from the regulatory industry, contract houses and EU regulatory agencies. The formal presentations are combined with interactive workshops and breakout sessions.

At the end of each day we turn theory into practice by looking at a tailored case study, tackling realistic regulatory challenges. You will work in a team and develop your communication skills.

With a high facilitator-to-delegate ratio, there is always someone available to answer questions.



Quotes about our previous courses:

"This course has given me a good foundation knowledge in a wide range of regulatory affairs activities, which I hope to build upon during my career."


"After being a consultant for 10 months and having heard of many of the topics, I now finally got a theoretical background. This greatly strengthened my position and confidence when working with various clients."


"The main learning points for me were a better understanding of the legal framework for obtaining MA in the EU. I have already been able to use this during client meetings in being able to provide better advice regarding the clinical development strategy."


"I have the wonderful notes to refer back to, which I will probably keep for the rest of my working career as my other colleagues have."


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