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

• Date:
  Thursday, 26 May 2011, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

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.

Documents

Agenda - Workshop for micro, small and medium-sized enterprises (SMEs) organised by the SME office "Focus on Scientific and Regulatory Advice"

Reference Number: EMA/204912/2011

Presentation - Update from SME office, Ms Melanie Carr

Presentation - SME’s perspective on scientific and regulatory advice, Dr. Lene Rose Arfelt

Presentation - Scientific advice on quality aspects – key considerations, Prof. Dieter Deforce

Presentation - Recent experience in non-clinical scientific advice, Dr. Jan-Willem van der Laan

Presentation - Scientific advice on clinical aspects – key considerations, Dr. Bertil Jonsson

Presentation - Innovation task force (ITF), Dr. Marisa Papaluca Amati

Presentation - Orphan designation – key concepts and evaluation criteria, Dr. Jordi Llinares

Presentation - Paediatrics, Dr. Matthew Thatcher

Presentation - Advanced therapy medicinal products (ATMPs), Prof. Jean-Hugues Trouvin

Presentation - Veterinary experience with scientific and regulatory advice, Dr. Karen Quigley

Presentation - Advice on regulatory strategy, Ms Zaide Frias

Presentation - Meeting rapporteur/co-rapporteur prior to filing, Dr. Bertil Jonsson

Presentation - Support available to SMEs nationally and internationally – Afssaps, Dr. Stephane Palies

Presentation - Support available to SMEs nationally and internationally – PEI, Ms Bettina Ziegele

Presentation - Support available to SMEs nationally and internationally – FDA, Ms Brenda Stodart