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
Location: TOPRA Office, 3rd Floor City Reach, 5-6 Greenwich View Place, London E14 9NN, UK

Also available as a virtual course, please click here for the virtual 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

Alexis Cockroft

Alexis Cockroft
Director and Regulatory Consultant
Lex Regulatory Ltd
 
Andrew Thornley, UCB

Sheetal Vaidya, G&L
  

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
Member: £620+VAT
Non Member: £720+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 receive 25% discount. 
Those working for charities, patient groups or in full-time education receive 50% discount.
  

*VAT, if applicable, is charged at the rate of 20%

Related courses

Next steps
When
06/08/2025
Where
TOPRA 3rd Floor City Reach 5-6 Greenwich View Place London UNITED KINGDOM
Online registration not available.
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NOTE
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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