Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation

• Date:
  Friday, 25 May 2012, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The objectives of the meeting are to present an update to the implementation process, key feedback from recent consultations, questions and answers on the transitional period, specific considerations for biological medicines and feedback on other topics. Registration by invitation only.

Documents

Agenda – Fifth stakeholders forum on the implementation of the new pharmacovigilance legislation

Reference Number: EMA/284201/2012

List of participants - Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation, 25 May 2012

Reference Number: EMA/289380/2012

Presentation - Pharmacovigilance in European Union: where have we come from?

Presentation - Implementation of the new pharmacovigilance legislation: planning and processes

Presentation - Implementation of the pharmacovigilance legislation

Presentation - Good pharmacovigilance practices: Key themes from the public consultation and next steps

Presentation - Session on identification and traceability of biological products

Presentation - Traceability of biopharmaceuticals in spontaneous reporting systems

Presentation - Identification and traceability of biological products: European Generic Medicines Association views

Presentation - Identification and traceability of biological products

Presentation - New pharmacovigilance legislation: Questions and answers on practical transitional measures

Presentation - Summaries of risk management plan

Presentation - The PRAC in PRACtice

Presentation - Current status and update of the Article 57(2) implementation

Presentation - Impact on the product information of the additional monitoring of medicines

Multimedia