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ACADEMIC RECOGNITION OF 3 OR 6 CREDITS


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, Sue Rees (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.

Applications currently closed

Application to this training will be available
from January 27th, 2025 to September 07th, 2025.
Thanks for applying during this period.

Contact the Eu2P Central Office

Applications will open on January 27th, 2025. Please contact the Eu2P Central Office for information.

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

Master Year 2 PhD



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