European Medicines Agency roundtable with stakeholders on the 10-year anniversary of the Micro-, small- and medium-sized-enterprise (SME) office

• Date:
  Friday, 27 November 2015, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

On 15 December 2015 the Commission Regulation (EC) No 2049/2005 (SME Regulation) reaches a 10-year anniversary milestone. To mark the occasion, the European Medicine Agency's SME Office is hosting this roundtable meeting with stakeholders.The objectives of the meeting will be to provide an update on the 10 years since the implementation of the SME initiative, and to present the results of the most recent EMA SME survey. A tour de table with stakeholders will follow, and all invited speakers and participants will have the opportunity to exchange views on achievements, challenges and opportunities in light of the themes identified in the latest SME Survey.

Documents

Programme - European Medicines Agency roundtable with stakeholders on the 10-year anniversary of the SME office

Reference Number: EMA/719296/2015

Report on the European Medicines Agency roundtable meeting with stakeholders - 10th anniversary of the SME initiative

Reference Number: EMA/821368/2015

Presentation - European strategy for SMEs in the pharmaceutical legislation: Directorate General for Health and Consumers (Andrzej Rys)

Presentation - Directorate General for Research and Innovation perspective (Antoine Mialhe)

Presentation - Micro-, small- and medium-sized-enterprise (SME) Policy : DG Internal market (Krista De Spiegeleer)

Presentation - 10-Year anniversary of the SME Office (Constantinos Ziogas)

Presentation - SME survey 2015 – Taking stock of the experience gained with the Agency’s SME initiative 10 years after its launch (Angela-Christina Schmidt)

Presentation - Cell Therapy Limited (Ajan Reginald)

Presentation - The experience of biotech SMEs with Commission Regulation (EC) No 2049/2005 (SME Regulation) : The Europa Association for Bioindustries (EuropaBio) (Miriam Gargesi)

Presentation - European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) (Alexander Natz)

Presentation - Europharm SMC feedback (Telma Costa)

Presentation - Barriers to growth for the biopharmaceutical sector in Europe: European Federation of Pharmaceutical Industries and Associations (EFPIA) (Marc de Garidel)

Presentation - Stakeholder feedback : Vaccines Europe (Christopher Bailey)

Presentation - European CRO Federation (EUCROF) (Stefano Marini)

Presentation - European Group for Generic Veterinary Products (EGGVP) comments (Elsa Vecino)

Presentation - EU Innovation Network : Paul-Ehrlich-Institut (Bettina Ziegele)