Sixth workshop for micro, small and medium-sized enterprises (SMEs) - Focus on scientific and regulatory advice

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TitleSixth workshop for micro, small and medium-sized enterprises (SMEs) - Focus on scientific and regulatory advice
Date26/05/2011 - 26/05/2011
LocationLondon
SummaryOn 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.

All documents

Name Language First published Last updated
Agenda - Workshop for micro, small and medium-sized enterprises (SMEs) organised by the SME office "Focus on Scientific and Regulatory Advice" (English only) 2011-03-24 2011-06-06
Presentation - Update from SME office, Ms Melanie Carr (English only) 2011-06-06  
Presentation - SME’s perspective on scientific and regulatory advice, Dr. Lene Rose Arfelt (English only) 2011-06-06  
Presentation - Scientific advice on quality aspects – key considerations, Prof. Dieter Deforce (English only) 2011-06-06  
Presentation - Recent experience in non-clinical scientific advice, Dr. Jan-Willem van der Laan (English only) 2011-06-06  
Presentation - Scientific advice on clinical aspects – key considerations, Dr. Bertil Jonsson (English only) 2011-06-06  
Presentation - Innovation task force (ITF), Dr. Marisa Papaluca Amati (English only) 2011-06-06  
Presentation - Orphan designation – key concepts and evaluation criteria, Dr. Jordi Llinares (English only) 2011-06-06  
Presentation - Paediatrics, Dr. Matthew Thatcher (English only) 2011-06-06  
Presentation - Advanced therapy medicinal products (ATMPs), Prof. Jean-Hugues Trouvin (English only) 2011-06-06  
Presentation - Veterinary experience with scientific and regulatory advice, Dr. Karen Quigley (English only) 2011-06-06  
Presentation - Advice on regulatory strategy, Ms Zaide Frias (English only) 2011-06-06  
Presentation - Meeting rapporteur/co-rapporteur prior to filing, Dr. Bertil Jonsson (English only) 2011-06-06  
Presentation - Support available to SMEs nationally and internationally – Afssaps, Dr. Stephane Palies (English only) 2011-06-06  
Presentation - Support available to SMEs nationally and internationally – PEI, Ms Bettina Ziegele (English only) 2011-06-06  
Presentation - Support available to SMEs nationally and internationally – FDA, Ms Brenda Stodart (English only) 2011-06-06  

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Contact point:

Cathrin Budnik
smeoffice@ema.europa.eu