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A Practical Guide to Pharmacovigilance

10 Module eBook

Study in your own time

Online Learning

Pharmacovigilance is a crucial business component for any pharmaceutical company - just like the manufacturing of a F1 car or a fighter jet, safety is an imperative consideration for the manufacturers. Good benefit-risk management and communication is crucial to business success. A core part of good benefit-risk management is ensuring that there is optimal awareness through collection, collation, assessment, and appropriate response to all available safety information.

This 10 module online course will enable you to understand key regulations and guidelines relating to Pharmacovigilance and give you guidance on how to achieve compliance with these standards.


This course provides:

  • End of module quizzes
  • Final exam once you have completed the course
  • Access to a discussion forum
  • Option to email the author with questions
  • Certificate - CPD Certified

This 10 module course will provide you with information about the key aspects of Pharmacovigilance:

  • Ensure your drug safety activities are performed in compliance with regulatory requirements
  • Keep abreast of safety reporting requirements so that you can run an efficient and compliant safety department
  • Plan an effective surveillance system to monitor potential safety signals and manage risk/benefit for your products
  • Prepare for pharmacovigilance inspections conducted by regulatory agencies
  • Protect your company and your products

Arthur Meiners

Arthur P. Meiners studied medicine in Rotterdam and then trained and worked as an internist-nefrologist. He joined the Dutch Agency for the Medicines Evaluation Board in 1991 where he set up and headed the pharmacovigilance department. In 2001 he became QPPV for J&J, advisory board member to the Pharmacovigilance Platform Netherlands, joined the (PhRMA) EU Pharmacovigilance working group, and from 2002 to 2008 was a board member of Janssen Cilag International.

Since early 2010 he is available as a pharmacovigilance consultant for PV projects, including issue management, system review & improvement and training.


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