Training session on the new pharmaceutical legislation

• Date:
  Thursday, 29 November 2012, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This training session for patient- and consumer-organisation representatives is focusing on the new pharmacovigilance legislation; the Pharmacovigilance Risk Assessment Committee (PRAC); risk-management plans and post-authorisation safety studies; adverse-drug-reaction reporting and signal detection; periodic safety update reports; safety referrals; and the impact of the pharmacovigilance legislation.

Documents

Agenda - Training session on the new pharmaceutical legislation, 29 November 2012

Reference Number: EMA/483816/2012

Presentation - Setting the scene: New European Union pharmacovigilance legislation (P. Arlett)

Presentation - Pharmacovigilance legislation: Our implementation journey... (F. Diafouka)

Presentation - Good pharmacovigilance practices (P. Bahri)

Presentation - Lifecycle of a new medicinal product (N. Bere)

Presentation - The Pharmacovigilance Risk Assessment Committee mandate, composition and tasks (R. De Lisa)

Presentation - How we communicate the outcome of safety reviews (M. Benstetter)

Presentation - Risk management (S. Blackburn)

Presentation - Measuring the effectiveness of risk-minimisation measures (A. Rubino)

Presentation - Non-interventional post-authorisation safety studies: Definition, obligations and requirements (A. Rubino)

Presentation - Reporting side effects of medicines (V. Newbould)

Presentation - Public website of side effects (V. Newbould)

Presentation - Signal detection and management (G. Genov)

Presentation - Medicinal products subject to additional monitoring (M. Arriegas)

Presentation - Periodic-safety-update-report procedure and concept of benefit-risk evaluation (R. Postigo)

Presentation - Referral procedures (A. Marcal, H. Matos and V. Seguin)

Presentation - Additional monitoring of medicines and side-effect reporting: Impact on the product information (C. Espinasse)

Presentation - European-public-assessment-report summaries (D. Glanville)