Pharmacovigilance and Risk Management

The guideline on GVP was a key deliverable of the 2010 pharmacovigilance legislation.

Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.

The guideline on GVP is divided into chapters that fall into two categories:

modules covering major pharmacovigilance processes;

.product- or population-specific considerations.

.Modules covering major pharmacovigilance processes

 

  • risk management
  • Drug
  • bioequivalence
  • generic drugs

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