Workshop for micro, small and medium-sized enterprises (SMEs) - European Medicines Agency regulatory support pre- and post-authorisation

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TitleWorkshop for micro, small and medium-sized enterprises (SMEs) - European Medicines Agency regulatory support pre- and post-authorisation
Date26/04/2013 - 26/04/2013
LocationEuropean Medicines Agency, London, UK
SummaryWorkshops for micro, small and medium-sized enterprises (SMEs) take place at the European Medicines Agency (EMA) annually, and have been organised by the SME Office since 2007.This year's regulatory workshop aims to provide practical information for SMEs working in the human medicines field. Topics to be covered include orphan designation, scientific advice, the centralised application for marketing authorisation and pharmacovigilance.The workshop is open to companies that have been assigned SME status by the EMA and to representatives of stakeholder organisations.

All documents

Name Language First published Last updated
Agenda - Workshop programme - Pre- and post-authorisation regulatory support for micro, small and medium-sized enterprises (English only) 2013-03-08 2013-05-06
Presentation - Key concepts of orphan designation and latest developments (Jordi Llinares) (English only) 2013-05-06  
Presentation - Key concepts of the Paediatric Regulation and latest developments (Paolo Tomasi) (English only) 2013-05-06  
Presentation - Scientific advice (Jane Moseley) (English only) 2013-05-06  
Presentation - Innovation Task Force (Marisa Papaluca) (English only) 2013-05-06  
Presentation - Introducing the Innovation Office at the Swedish Medical Products Agency (Lars Dagerholt) (English only) 2013-05-06  
Presentation - French National Agency for Medicines and Health Products Safety: Innovation Office (Francois Cuenot) (English only) 2013-05-06  
Presentation - Marketing-authorisation application pre-submission issues and European Medicines Agency meeting opportunities (Irene Rager) (English only) 2013-05-06  
Presentation - Data exclusivity, market protection and paediatric rewards (Zaide Frias) (English only) 2013-05-06  
Presentation - A micro-, small- and medium-sized-enterprise perspective on the marketing-authorisation-application process (including e-dossier preparation and submission)(Martine Zimmermann) (English only) 2013-05-06  
Presentation - Implementation of the new pharmacovigilance legislation: Overall update and activities in 2013 (Franck Diafouka) (English only) 2013-05-06  
Presentation - Good pharmacovigilance practices (GVP) and requirements for marketing-authorisation holders (Priya Bahri) (English only) 2013-05-06  
Presentation - Key considerations in risk-management plans (Maarten Lagendijk) (English only) 2013-05-06  

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