Essentials of European Pharmaceutical Regulatory Affairs

Essentials of European Pharmaceutical Regulatory Affairs
This course will provide a basic but comprehensive overview of pharmaceutical regulatory affairs in a relaxed and interactive environment.

Date:
 6 August 2025
Time: 09:30-16:30 CET
Location: Online

Also available as an in-person course, please click here for this registration option.

Course overview

This popular course provides an opportunity that on-the-job learning doesn't: network and learn from a variety of experts, including your fellow delegates. By attending this course, you will:

  • Get a clear understanding of the roles played by regulatory affairs professionals obtaining and maintaining marketing authorisation for medicines
  • Learn the key steps involved in developing new pharmaceuticals
  • Gain an overview of EU legislative framework and regulatory procedures
  • Get insights about the strategies needed to be applied by regulatory affairs professionals to obtain best results for their organisations and stakeholders
  • Understand life-cycle management procedures including variations, the essentials of clinical trials and importance of labelling


Benefits to delegates

  • Get a complete grounding in regulatory affairs in just one day 
  • Be taught by regulatory affairs experts with extensive practical examples 
  • Understand the regulatory affairs sector and find out for yourself how you can maximise your performance, either as a regulatory professional or working alongside regulatory colleagues
  • Build a network to support the rest of your career

CPD: This course provides 6 CPD hours upon successful completion

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

Programme

The draft programme for this course can be downloaded here.

Presenters



Claire McDonald, GSK




 

 

 

Suitable for

This course is designed for those:

  • Who are new to regulatory affairs
  • Who wish to move into the profession
  • From related professions (law, pharmaceutical manufacturing, marketing and sales, healthcare, administration, project management)
  • Who would gain by obtaining better insight about the world of their partners in regulatory affairs
  • Those who work in regulatory authorities and those in the regulatory sector

 

Pricing  

Course *fees:
Type Fee
Standard    £615+VAT

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

Those working for regulatory agencies, government agencies or academic institutions 
 £461.25+VAT
Those working for charities, patient groups or in full-time education
 £307.50+VAT

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



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Next steps

When
06/08/2025
Where
Online
Online registration not available.
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Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

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