Sixth workshop for micro, small and medium-sized enterprises (SMEs) - Focus on scientific and regulatory advice
Date:
26/05/2011
Location:
London
On 26 May 2011, the EMA hosted its 6th SME Workshop, titled "Focus on Scientific and Regulatory Advice" with more than 160 representatives of SMEs and their stakeholders participating. The various opportunities for early dialogue and advice from the Agency were presented, with recent experience in quality, non-clinical and clinical scientific advice highlighted. The workshop also covered regulatory issues relating to an application for marketing authorisation, and national initiatives to support SMEs in France, Germany and in the USA from CDER's Small Business Assistance Division.
-
List item
Agenda - Workshop for micro, small and medium-sized enterprises (SMEs) organised by the SME office "Focus on Scientific and Regulatory Advice" (PDF/88.84 KB)
First published: 24/03/2011
Last updated: 06/06/2011
EMA/204912/2011 -
List item
Presentation - Update from SME office, Ms Melanie Carr (PDF/441.13 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - SME’s perspective on scientific and regulatory advice, Dr. Lene Rose Arfelt (PDF/402.99 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Scientific advice on quality aspects – key considerations, Prof. Dieter Deforce (PDF/157.53 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Recent experience in non-clinical scientific advice, Dr. Jan-Willem van der Laan (PDF/501.75 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Scientific advice on clinical aspects – key considerations, Dr. Bertil Jonsson (PDF/446.98 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Innovation task force (ITF), Dr. Marisa Papaluca Amati (PDF/388.04 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Orphan designation – key concepts and evaluation criteria, Dr. Jordi Llinares (PDF/555.4 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Paediatrics, Dr. Matthew Thatcher (PDF/214.16 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Advanced therapy medicinal products (ATMPs), Prof. Jean-Hugues Trouvin (PDF/746.11 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Veterinary experience with scientific and regulatory advice, Dr. Karen Quigley (PDF/140.31 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Advice on regulatory strategy, Ms Zaide Frias (PDF/910.41 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Meeting rapporteur/co-rapporteur prior to filing, Dr. Bertil Jonsson (PDF/194.49 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Support available to SMEs nationally and internationally – Afssaps, Dr. Stephane Palies (PDF/465.6 KB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Support available to SMEs nationally and internationally – PEI, Ms Bettina Ziegele (PDF/1.35 MB)
First published: 06/06/2011
Last updated: 06/06/2011 -
List item
Presentation - Support available to SMEs nationally and internationally – FDA, Ms Brenda Stodart (PDF/253.99 KB)
First published: 06/06/2011
Last updated: 06/06/2011