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TOPRA

Healthcare Regulatory Affairs

More info about TOPRA

Course: Basics of Regulatory Affairs

TOPRA

A one-day introductory course for very new recruits, PAs, administrators and support staff in Regulatory Affairs. Suitable for staff in agencies and companies. This course is now in its 14th successful year.

2010 Dates:

  • Wednesday 10 February 2010
  • Wednesday 24 March 2010
  • Wednesday 19 May 2010
  • Wednesday 11 August 2010
  • Wednesday 20 October 2010

Venue: Danubius Hotel, 18 Lodge Road, London, NW8 7JT.

The purpose of the day

The world of Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry background. The purpose of this course is to provide you with a clear and concise understanding of the role played by Regulatory Affairs in obtaining and maintaining Marketing Authorisations for pharmaceutical products.

The course tutors

All of the tutors on this course have many years of Regulatory Affairs experience and are currently working in the industry.

What previous delegates have had to say about this course:
“Speakers very clear, concise and informative”
“Excellent overview in such a short time!”
“Made things a lot clearer and gave me an understanding of how things link together.”
“Well structured set of presentations and very informative.”

What you will learn:

  • Regulatory Affairs: What is it and why is it needed?
  • The role of the Regulatory Affairs professional within a company
  • The role of the Regulatory Affairs professional – working with external Regulatory agencies and other bodies
  • The European legislative framework
  • How pharmaceuticals are controlled
  • The contents of a basic application dossier
  • Basic data requirements
  • Overview of drug development
  • Overview of clinical trials
  • Marketing Authorisation Applications
  • European procedures
  • Post licensing
  • Labels and leaflets
  • Variations
  • And there will be quizzes and prizes too!

Our Promise: We guarantee you will leave the course with a better understanding of the regulatory process and your role within it.

For more information, please visit www.topra.org/basics

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