GVP Module VI - online training course

PIPA Online Training: GVP Module VI

Cost:  £40.00 + VAT (please note there is an additional £15.00 + VAT admin fee to request an invoice)

To book: http://www.pipaonline.org/Events/ModuleV1---Management-Reporting-of-Adverse-Reactions-to-Medicinal-Products/16657

If you’re looking to get to grips with the regulations and guidelines for the collection and reporting of adverse events, this course will provide you with a good introduction and equip you with the fundamental principles of Pharmacovigilance.

The course is written by Pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module VI (Management and reporting of adverse reactions to medicinal products) of the Guideline on Good Pharmacovigilance Practices released by the European Medicines Agency in June 2012.

The course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with drug safety e.g. all Medical Information professionals. It is also an ideal course for those providing medical review and for  PV professionals with a number of years of experience, but who would like a refresher and/or require evidence  of their training on, and understanding of, the GVP Modules.

Accessing this course will enable delegates to: 

  • Learn the key definitions and industry terms
  • Find out more about the European regulations and guidelines
  • Understand what adverse events are and how they are collected
  • Learn how to identify an adverse event
  • Know what information to collect for an adverse event report
  • Learn the reporting timeframes

Links are provided to other important sources of information.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience:

New PV professionals.
Individuals in departments that work closely with PV
Those providing medical review
PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module VI

 

Time: 1 -2 hours

 

 
Level of difficulty: Introductory / intermediate