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Essentials of European Pharmaceutical Regulatory Affairs




London, United Kingdom


22 Nov 2018

Reference No: T1802226 - TOP

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Key points about this Training Event

  • This course is designed for those who are new to regulatory affairs and require an overview of the profession
  • Particularly those from related disciplines (eg manufacturing, marketing and sales, support staff, etc.) and those wishing to move into the profession
Event Description

Course outline:

This course will provide a basic grounding of the regulatory affairs profession in a relaxed, enjoyable environment

This course will cover

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

CPD: 5 (Continuing Professional Development)

When and Where?

22 November 2018

TOPRA Office
6th Floor 3 Harbour Exchange
South Quay
London, E14 9GE United Kingdom


Course fee for Delegates : £580.00 plus 20% VAT

Applicant Requirements
  • Anyone wishing to move into the regulatory affairs profession
Reference No: T1802226 - TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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