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DESIGNED FOR EXPERTS BY EXPERTS


PHARMACOVIGILANCE REGULATIONS


Eu2P Certificate: Pharmacovigilance regulations

OBJECTIVES

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.

Regulations, legislation, directives, guidelines, databases, coding

 

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: Ms Marika Vousden (from University of Hertfordshire)

Expert(s): Dr Sherael Webley, Bharat Amlani, Sue Rees (from University of Hertfordshire), Tara Ferguson, Elisabeth Swain, Dr Jens-Ulrich Stegmann, Subhash Mistry (from GlaxoSmithKline Research and Development Ltd), Panos Tsintis (from NDA Regulatory Science), John Talbot (from AstraZeneca AB), Leigh Gear (from Amgen NV), Edward Stewart Geary (from Eisai), William Gregory (from Pfizer), Vicki Page-Clark (Independent), Dr John Poustie (from Norgine), Caroline Rainsford (from Cosmetic, Toiletry and Perfumery Association), Kristina Black (from Gilead Sciences).

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 08th, 2024

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

Master Year 2 PhD



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