Training session on the new pharmaceutical legislation

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TitleTraining session on the new pharmaceutical legislation
Date29/11/2012 - 29/11/2012
LocationEuropean Medicines Agency, London, UK
SummaryThis 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.

All documents

Name Language First published Last updated
Agenda - Training session on the new pharmaceutical legislation, 29 November 2012 (English only) 23/11/2012 28/01/2013
Presentation - Setting the scene: New European Union pharmacovigilance legislation (P. Arlett) (English only) 28/01/2013  
Presentation - Pharmacovigilance legislation: Our implementation journey... (F. Diafouka) (English only) 28/01/2013  
Presentation - Good pharmacovigilance practices (P. Bahri) (English only) 28/01/2013  
Presentation - Lifecycle of a new medicinal product (N. Bere) (English only) 28/01/2013  
Presentation - The Pharmacovigilance Risk Assessment Committee mandate, composition and tasks (R. De Lisa) (English only) 28/01/2013  
Presentation - How we communicate the outcome of safety reviews (M. Benstetter) (English only) 28/01/2013  
Presentation - Risk management (S. Blackburn) (English only) 28/01/2013  
Presentation - Measuring the effectiveness of risk-minimisation measures (A. Rubino) (English only) 28/01/2013  
Presentation - Non-interventional post-authorisation safety studies: Definition, obligations and requirements (A. Rubino) (English only) 28/01/2013  
Presentation - Reporting side effects of medicines (V. Newbould) (English only) 28/01/2013  
Presentation - Public website of side effects (V. Newbould) (English only) 28/01/2013  
Presentation - Signal detection and management (G. Genov) (English only) 28/01/2013  
Presentation - Medicinal products subject to additional monitoring (M. Arriegas) (English only) 28/01/2013  
Presentation - Periodic-safety-update-report procedure and concept of benefit-risk evaluation (R. Postigo) (English only) 28/01/2013  
Presentation - Referral procedures (A. Marcal, H. Matos and V. Seguin) (English only) 28/01/2013  
Presentation - Additional monitoring of medicines and side-effect reporting: Impact on the product information (C. Espinasse) (English only) 28/01/2013  
Presentation - European-public-assessment-report summaries (D. Glanville) (English only) 28/01/2013  

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