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Essentials of European Regulatory Affairs, United States

Essentials of European Regulatory Affairs, United States
This course will provide you with the opportunity to learn about European Regulatory Affairs direct from the source.

: 18 March 2019
Where: Celgene, 86 Morris Avenue, Summit, NJ 07901, USA
Time: 08:30 - 16:00

Course overview

This course provides an opportunity that on-the-job learning doesn't: network and learn from 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
  • Get insights about the strategies needed to be applied by regulatory affairs professionals to obtain best results for their organisations and stakeholders
  • Gain an overview of EU legislative framework
  • Understand the essentials of clinical trials, EU marketing authorisation procedures, labeling, advertising, post-authorisation activities, including variations, and EU specific challenges.

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 7 CPD hours upon successful completion

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


8:30 - 9:00  Registration
9:00 - 16:00  Course

Breaks at various times during the course programme.


Carlos Langezaal - Senior Director, Regulatory Affairs, Celgene

Suitable for

This course is designed for those who are new to, or need a refresher of European Regulatory Affairs.


Course fees:

Type Fee
Standard    £399
(approx equivalent cost US$500)
  • The registration fee does not include accommodation
  • Refreshments and lunch are included in the registration fee

Related courses

Next steps

18/03/2019 08:30 - 16:00
Essentials of European Regulatory Affairs Celgene 86 Morris Avenue Summit, NJ NJ 07901 UNITED STATES
Online registration not available.
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