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Basics of EU Pharmaceutical Regulatory Affairs Course

18 May, Bangalore, India

Regulatory Affairs can be a confusing and complex place particularly if you have no formal industry background.

Our highly-acclaimed one-day Basics course is coming to Bangalore and will provide you with an awareness of the regulatory environment in Europe and an appreciation of some of the main regulatory processes and issues.

This course is ideal for:

  • Those new to regulatory affairs or those wishing to move into the profession
  • Experienced staff from related disciplines, eg manufacturing, marketing and sales
  • Support staff
  • Anyone requiring an overview of regulatory affairs

What you will learn

  • Background to regulatory affairs
  • The European legislative framework
  • Overview of drug development
  • Overview of clinical trials
  • Marketing Authorisation Applications
  • Labels and leaflets
  • European Procedures
  • Lifecycle management, including variations
  • This course will give a basic grounding in a relaxed, enjoyable environment

What previous delegates said about this course…

"Speakers very clear, concise and informative"

"Excellent overview in such a short time!"

"Well structured set of presentations and very informative."

"Made things a lot clearer and gave me an understanding of how things link together."

Basics Course programme

Time Presentation
9:30 Introduction to TOPRA
9:50 Introductions
10:00 Setting the Scene
10:25 Overview of Drug Development
11:00 Coffee
11:10 Regulatory Control of Clinical Trials
11:30 Marketing Authorisation Applications
12:00 Product Information (Labelling)
12:10 SmPC game
12.40 Lunch
13.40 European Marketing Authorisation Procedures
14.40 Marketing Authorisation Strategy
14:50 Post- Authorisation Activities
15:10 Review
15:50 Wrap up (Close 16:00)

Programme subject to change