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

EventCorporateMedicinesSME

Date: Friday, 26 April 2013, All day
Location: European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Workshop programme - Pre- and post-authorisation regulatory support for micro, small and medium-sized enterprises

Reference Number: EMA/214813/2013

English (EN) (270.64 KB - PDF)

First published: 08/03/2013 Last updated: 06/05/2013

Presentation - Key concepts of orphan designation and latest developments (Jordi Llinares)

English (EN) (2.55 MB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Key concepts of the Paediatric Regulation and latest developments (Paolo Tomasi)

English (EN) (1.42 MB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Scientific advice (Jane Moseley)

English (EN) (697.38 KB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Innovation Task Force (Marisa Papaluca)

English (EN) (1.15 MB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Introducing the Innovation Office at the Swedish Medical Products Agency (Lars Dagerholt)

English (EN) (918.81 KB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - French National Agency for Medicines and Health Products Safety: Innovation Office (Francois Cuenot)

English (EN) (182.74 KB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Marketing-authorisation application pre-submission issues and European Medicines Agency meeting opportunities (Irene Rager)

English (EN) (889.73 KB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Data exclusivity, market protection and paediatric rewards (Zaide Frias)

English (EN) (440.91 KB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - A micro-, small- and medium-sized-enterprise perspective on the marketing-authorisation-application process (including e-dossier preparation and submission)(Martine Zimmermann)

English (EN) (1.2 MB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Implementation of the new pharmacovigilance legislation: Overall update and activities in 2013 (Franck Diafouka)

English (EN) (1.49 MB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Good pharmacovigilance practices (GVP) and requirements for marketing-authorisation holders (Priya Bahri)

English (EN) (258.76 KB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

Presentation - Key considerations in risk-management plans (Maarten Lagendijk)

English (EN) (537.7 KB - PDF)

First published: 06/05/2013 Last updated: 06/05/2013

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