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ACADEMIC RECOGNITION OF 3 OR 6 CREDITS


DESIGNED FOR EXPERTS BY EXPERTS


PHARMACOVIGILANCE REGULATORY PROCESSES


OBJECTIVES



To enable participants (specialists) to develop an understanding of the requirements of the Pharmaceutical Industry’s operational aspects of pharmacovigilance as it relates to the preparation and assessment of documents legally required by regulatory bodies.

Focus will be on the adverse event reporting process within Industry, placed within the context of regulatory requirements and best practice.

Legislation, regulation, processes, procedures, documentation

 

MODULE PARTS



  1. Case reporting
  2. Periodic reporting
  3. Product Labelling and Risk Management Plans
  4. Contractual arrangements.

 

TRAINER TEAM



Coordinator: Dr Sherael Webley (from University of Hertfordshire)

Expert(s): Dr Marika Vousden, Bharat Amlani (from University of Hertfordshire), John Talbot, Dr James Whitehead (from AstraZeneca AB), Dr Justina Orleans-Lindsay (from Acadustri Ltd), Robert Grice, Dr Michael Perrio (from GlaxoSmithKline Research and Development Ltd), Helen Robinson (from Pfizer), Dr David Lewis (from Novartis Pharma AG), Philippa Guy (from Saffron Health), Dr Sarah Hall (from Baxter International Inc.), Dr Susan Duke (from F. Hoffmann-La Roche Ltd).

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 closed on December 09th, 2018.
You will be able to apply to the next training session
from April 08th, 2019 to December 08th, 2019.

Contact the Eu2P Central Office

Next session application will start on April 08th, 2019.
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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