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Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA) (PDF/165.3 KB) (new)

First published: 29/01/2020
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Minutes of the COMP meeting 8-10 October 2019 (PDF/378.61 KB) (new)

Adopted
First published: 29/01/2020
EMA/COMP/550965/2019
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European Medicines Agency EORTC workshop on novel PRO and QoL approaches in cancer clinical research

European Medicines Agency, Amsterdam, the Netherlands, from 12/03/2020 to 13/03/2020, Last updated: 29/01/2020
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Agenda - EMA EORTC workshop on novel PRO and QoL approaches in cancer clinical research (PDF/146.53 KB) (new)

Draft
First published: 29/01/2020
EMA/668786/2019
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Munich

Munich, Germany, from 29/06/2020 to 01/07/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam

Amsterdam, Netherlands, from 15/06/2020 to 17/06/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Paris

Paris, France, from 08/06/2020 to 10/06/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Vienna

Vienna, Austria, from 11/05/2020 to 13/05/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam

Amsterdam, Netherlands, from 06/05/2020 to 08/05/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Lisbon

Lisbon, Portugal, from 11/05/2020 to 13/05/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Prague

Prague, Czechia, from 22/04/2020 to 24/04/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Bucharest

Bucharest, Romania, from 01/04/2020 to 03/04/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Madrid

Madrid, Spain, from 25/03/2020 to 27/03/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam

Amsterdam, The Netherlands, from 04/03/2020 to 06/03/2020, Last updated: 29/01/2020
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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Dublin

Dublin, Ireland, from 09/03/2020 to 11/03/2020, Last updated: 29/01/2020
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Electronic product information for human medicines in the European Union - key principles (PDF/1.78 MB) (new)

Adopted
First published: 29/01/2020
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Electronic product information for human medicines in the European Union - Contributions received following public consultation (partially anonymised) (PDF/2.32 MB) (new)

First published: 29/01/2020
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Electronic product information for human medicines in the European Union - Categorised comments received following public consultation (partially anonymised) (XLS/638 KB) (new)

First published: 29/01/2020
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Key principles for the use of electronic product information for EU medicines (PDF/112.56 KB) (new)

First published: 29/01/2020
EMA/26061/2020
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News: Key principles for the use of electronic product information for EU medicines

Last updated: 29/01/2020
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Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles' (PDF/379.85 KB) (new)

First published: 29/01/2020
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Minutes of the HMPC 13-15 May 2019 meeting (PDF/250.88 KB) (new)

Adopted
First published: 29/01/2020
EMA/HMPC/403891/2019
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2020 European Union Good Clinical Practice Inspectors Working Group workshop

Seeheim-Jugenheim (close to Frankfurt am Main), Germany, from 30/09/2020 to 02/10/2020, Last updated: 29/01/2020
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Lemtrada Article 20 referral - Scientific conclusions (PDF/123.54 KB) (new)

First published: 29/01/2020
Bulgarian
(PDF/182.46 KB)

Croatian
(PDF/175.73 KB)

Czech
(PDF/178.27 KB)

Danish
(PDF/148.38 KB)

Dutch
(PDF/149.4 KB)

Estonian
(PDF/140.96 KB)

Finnish
(PDF/145.67 KB)

French
(PDF/150.55 KB)

German
(PDF/153.75 KB)

Greek
(PDF/188.13 KB)

Hungarian
(PDF/178.01 KB)

Italian
(PDF/146.1 KB)

Latvian
(PDF/187.99 KB)

Lithuanian
(PDF/187.75 KB)

Maltese
(PDF/186.34 KB)

Polish
(PDF/172.97 KB)

Portuguese
(PDF/148.58 KB)

Romanian
(PDF/178.09 KB)

Slovak
(PDF/166.7 KB)

Slovenian
(PDF/182.44 KB)

Spanish
(PDF/147.82 KB)

Swedish
(PDF/149.25 KB)
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COMP meeting report on the review of applications for orphan designation: January 2020 (PDF/255.63 KB) (new)

Adopted
First published: 29/01/2020
EMA/COMP/426032/2020

62098 results

Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA) (PDF/165.3 KB) (new)

Minutes of the COMP meeting 8-10 October 2019 (PDF/378.61 KB) (new)

European Medicines Agency EORTC workshop on novel PRO and QoL approaches in cancer clinical research

Agenda - EMA EORTC workshop on novel PRO and QoL approaches in cancer clinical research (PDF/146.53 KB) (new)

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Munich

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Paris

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Vienna

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Lisbon

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Prague

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Bucharest

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Madrid

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Amsterdam

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on training course using the EudraVigilance System - Dublin

Electronic product information for human medicines in the European Union - key principles (PDF/1.78 MB) (new)

Electronic product information for human medicines in the European Union - Contributions received following public consultation (partially anonymised) (PDF/2.32 MB) (new)

Electronic product information for human medicines in the European Union - Categorised comments received following public consultation (partially anonymised) (XLS/638 KB) (new)

Key principles for the use of electronic product information for EU medicines (PDF/112.56 KB) (new)

News: Key principles for the use of electronic product information for EU medicines

Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles' (PDF/379.85 KB) (new)

Minutes of the HMPC 13-15 May 2019 meeting (PDF/250.88 KB) (new)

2020 European Union Good Clinical Practice Inspectors Working Group workshop

Lemtrada Article 20 referral - Scientific conclusions (PDF/123.54 KB) (new)

COMP meeting report on the review of applications for orphan designation: January 2020 (PDF/255.63 KB) (new)