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
English (EN) (113.75 KB - PDF)
List of participants - Fifth stakeholder forum on the implementation of the new pharmacovigilance legislation, 25 May 2012
English (EN) (121.09 KB - PDF)
Presentation - Pharmacovigilance in European Union: where have we come from?
English (EN) (3.86 MB - PDF)
Presentation - Implementation of the new pharmacovigilance legislation: planning and processes
English (EN) (1.49 MB - PDF)
Presentation - Implementation of the pharmacovigilance legislation
English (EN) (98.92 KB - PDF)
Presentation - Good pharmacovigilance practices: Key themes from the public consultation and next steps
English (EN) (1.19 MB - PDF)
Presentation - Session on identification and traceability of biological products
English (EN) (906.26 KB - PDF)
Presentation - Traceability of biopharmaceuticals in spontaneous reporting systems
English (EN) (3.95 MB - PDF)
Presentation - Identification and traceability of biological products: European Generic Medicines Association views
English (EN) (852.79 KB - PDF)
Presentation - Identification and traceability of biological products
English (EN) (606.45 KB - PDF)
Presentation - New pharmacovigilance legislation: Questions and answers on practical transitional measures
English (EN) (490.36 KB - PDF)
Presentation - Summaries of risk management plan
English (EN) (327.02 KB - PDF)
Presentation - The PRAC in PRACtice
English (EN) (225.59 KB - PDF)
Presentation - Current status and update of the Article 57(2) implementation
English (EN) (447.14 KB - PDF)
Presentation - Impact on the product information of the additional monitoring of medicines
English (EN) (905.13 KB - PDF)
Multimedia
Contact point
Jolanta Palepsaitiene
jolanta.palepsaitiene@ema.europa.eu