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EU AND GLOBAL PHARMACOVIGILANCE REGULATORY FRAMEWORKS


Eu2P Certificate: EU and Global Pharmacovigilance Regulatory Frameworks

LEARNING OUTCOMES

To enable you to develop an understanding of European, USA and major local and worldwide regulations and guidelines concerning pharmacovigilance.

Emphasis will be placed on the problems of interpretation of pharmacovigilance regulations both pre- and post-authorisation.

GVP compliance, Good pharmacovigilance practices, pharmacovigilance regulations, EMA, regulatory compliance, PV Compliance Manager, Regulatory Affairs Manager

 

CAREER PROSPECTS

Primary target jobs are:

  • PV Compliance Manager
  • Regulatory Affairs Manager

Secondary or adjacent roles are:

  • Quality Assurance Specialist
  • Audit Manager

 

MODULE PARTS

  1. Pharmacovigilance regulations: concept
  2. The working Pharmacovigilance regulations.
  3. Other related Pharmacovigilance regulations and guidelines.
  4. Non-European pharmacovigilance regulations

 

TRAINER TEAM

Coordinator: Sue Rees (from University of Hertfordshire)

Expert(s): Dr Sherael Webley (from University of Hertfordshire), Dr Jens-Ulrich Stegmann, Subhash Mistry (from GlaxoSmithKline Research and Development Ltd), Edward Stewart Geary (from Eisai), Dr John Poustie (from Norgine), Dr James Whitehead (from AstraZeneca AB), Caroline Rainsford (from Cosmetic, Toiletry and Perfumery Association), Mark Baczkowski (from Sutro Biopharma, Inc.).

Intermediate level
75 h workload over 3 months (3 ECTS credits)
Key dates
Course calendar
Certificate award
or included in Master Year 2 or PhD programme
English language
Online based learning
Student : 1,500 €
Professional : 3,000 €
  Savings could be offered under eligibility conditions.

APPLY NOW

Applications open until September 06th, 2026

Or include this module in your training curriculum choices...

Master Year 2 PhD



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