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:
 9 November 2022
Time: 9:30-16:30 BST (GMT+1)
Location: TOPRA Office, 6th Floor, 3 Harbour Exchange, London, E14 9GE

This course is also available as an on-demand eLearning course, please click here to access the respective page.

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

I am very very new to regulatory, and lots of this information helped me to connect the dots in some areas that had previously been confusing.”  – 2020 delegate

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

Download a copy of the programme here

Presenters

To be announced

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

Standard

  • Member: £580+VAT*
  • Non-member: £580+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: £435+VAT
  • Those working for charities, patient groups or in full-time education: £290+VAT
*VAT, if applicable, is charged at the rate of 20%

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.

When
09/11/2022 09:30 - 16:30
Where
TOPRA 6th Floor 3 Harbour Exchange London E14 9GE UNITED KINGDOM
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