Workshop for micro, small and medium-sized enterprises (SMEs) - European Medicines Agency regulatory support pre- and post-authorisation
Date:
26/04/2013
Location:
European Medicines Agency, London, UK
Workshops 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.
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Agenda - Workshop programme - Pre- and post-authorisation regulatory support for micro, small and medium-sized enterprises (PDF/270.64 KB)
First published: 08/03/2013
Last updated: 06/05/2013
EMA/214813/2013 -
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Presentation - Key concepts of orphan designation and latest developments (Jordi Llinares) (PDF/2.55 MB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Key concepts of the Paediatric Regulation and latest developments (Paolo Tomasi) (PDF/1.42 MB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Scientific advice (Jane Moseley) (PDF/697.38 KB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Innovation Task Force (Marisa Papaluca) (PDF/1.15 MB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Introducing the Innovation Office at the Swedish Medical Products Agency (Lars Dagerholt) (PDF/918.81 KB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - French National Agency for Medicines and Health Products Safety: Innovation Office (Francois Cuenot) (PDF/182.74 KB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Marketing-authorisation application pre-submission issues and European Medicines Agency meeting opportunities (Irene Rager) (PDF/889.73 KB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Data exclusivity, market protection and paediatric rewards (Zaide Frias) (PDF/440.91 KB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - A micro-, small- and medium-sized-enterprise perspective on the marketing-authorisation-application process (including e-dossier preparation and submission)(Martine Zimmermann) (PDF/1.2 MB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Implementation of the new pharmacovigilance legislation: Overall update and activities in 2013 (Franck Diafouka) (PDF/1.49 MB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Good pharmacovigilance practices (GVP) and requirements for marketing-authorisation holders (Priya Bahri) (PDF/258.76 KB)
First published: 06/05/2013
Last updated: 06/05/2013 -
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Presentation - Key considerations in risk-management plans (Maarten Lagendijk) (PDF/537.7 KB)
First published: 06/05/2013
Last updated: 06/05/2013