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Progress made in the operation of EU pharmacovigilance legislation

The European Medicines Agency is organising the tenth stakeholder forum on the operation of the pharmacovigilance legislation on 21 September 2016.  

Stakeholders discuss achievements and future priorities

The European Medicines Agency (EMA) is organising the tenth stakeholder forum on the operation of the pharmacovigilance legislation on 21 September 2016. This is the latest in a series of events organised by EMA to review the progress made and to consult stakeholders on what needs to be the focus over the coming years.

The agenda of the forum is available. The event will be broadcast live on the EMA website.

Stakeholders’ input is essential for optimising the work of the pharmacovigilance system and ensuring its efficiency in promoting and protecting public health. Representatives of the pharmaceutical industry, regulatory authorities and patients and healthcare professionals will review the operation of EU pharmacovigilance and discuss achievements and future priorities.

Discussions will highlight:

  • current achievements and future priorities in the operation of Europeanpharmacovigilance;
  • regulatory science driving pharmacovigilance process improvement;
  • lifecycle pharmacovigilance planning for public health.

The European pharmacovigilance legislation has been instrumental to proactively plan the safety monitoring of medicines throughout their life cycle, starting from the product development stage, for the benefit of patients. It was enacted in 2012 to increase the effectiveness of this key public health function through better defined roles and responsibilities for the many stakeholders involved in safety monitoring of medicines, simplifying tasks, empowering patients, and allow for targeted administrative simplification.

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