Essentials of European Pharmaceutical Regulatory Affairs

Essentials of European Pharmaceutical Regulatory Affairs
Regulatory affairs can be a complex place, particularly if you have limited experience. Attend this course to get a clear understanding of the roles played by regulatory affairs professionals in obtaining and maintaining marketing authorisation for medicines; learn the key steps involved in developing new pharmaceuticals; and gain an overview of EU regulatory procedures and first insights about the strategies needed to be applied by regulatory affairs professionals to obtain best results for their organisations and stakeholders.

 30 July 2018
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom 

Course information

This course is designed for those who are new to regulatory affairs or wish to move into the profession, either to work for regulating authorities or for companies that develop and sell regulated medicinal products. Attendees may also come from related professions including law, pharmaceutical manufacturing, marketing and sales, healthcare, administration, project management, etc, who would gain by obtaining better insight about the world of their partners in regulatory affairs.

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. All speakers have many years of regulatory affairs experience and are currently working on the frontline in leading companies and consultancies.

This course will cover: 
  • Background to regulatory affairs, both "regulator" and "regulated"
  • The European legislative framework
  • Overview of drug development
  • Overview of clinical trials
  • Marketing authorisation applications
  • Labels and leaflets
  • European procedures
  • Lifecycle management, including variations and pharmacovigilance

CPD: at least 5 hours

Benefits for delegates

This course will benefit you in many ways. Some of the key reasons for you to attend include:

  • Get a complete background in regulatory affairs in just one day
  • Be taught by regulatory affairs experts from leading companies and consultancies
  • Understand the regulatory affairs sector and find out for yourself how you can maximise your own performance, either as a partner or change of career into this surprisingly diverse and varied profession
  • Network and learn from a variety of experts
  • Make valuable professional connections


Ivan FisherDr Ivan Fisher
Ivan has worked as a Regulatory Affairs Consultant for over 15 years, having completed his PhD in Molecular Biology from Imperial College, London. Currently Vice President, Regulatory Affairs at G&L Scientific, Ivan’s experience spans the pharmaceutical, consumer healthcare and generics industries. He received the TOPRA Distinguished Service Award in 2014.


Download the course programme here.


Type Registration fee
Standard    £580+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
Those working for charities, patient groups or in full-time education


Terms and conditions 

By booking a place on this course you are agreeing to the training terms and conditions. Please read them before booking this course.

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Related courses

Course repeat: Essentials of European Pharmaceutical Regulatory Affairs, 22 November, London
Online course: Basics of European Regulatory Affairs
On-demand Webinar: Your Career in Regulatory Affairs - Your First Steps

Next step

Introduction to Pharmaceutical Regulatory Affairs (The Autumn Introductory Course), 6 November, Prague, Czech Republic
30/07/2018 09:30 - 16:00
TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
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