Annual TOPRA Symposium - SME Day

Regulatory challenges and support for SME companies

Organised in conjunction with the Swedish Medical Products Agency and the support of EMEA

TOPRA in Stockholm: Symposium Preview

This special one day meeting for Small and Medium sized Enterprises (SME) starts with a morning devoted to SMEs where you will hear from the EMEA SME office, the experiences of a Swedish SME and the work of Europharm SMC followed by a panel session. In the afternoon you will be able to take part in the main TOPRA Annual Symposium which opens on the Wednesday afternoon.
This special day will provide SMEs with the opportunity to understand regulatory challenges specific to them and some of the wider issues for all sizes of industry.

Programme includes

• SME Office at EMEA
• Experience of a Swedish SME
• Europharm SMC

Speakers-morning

• Melanie Carr – SME Office, EMEA
• Annelie Skagerlind – Medivir, Sweden
• Telma Costa – Tecnifar SA, Portugal

Main TOPRA Annual Symposium (the remainder of the SME Day is common to the main Symposium)

Programme includes

• Best practice on the use of the Centralised Procedure for Marketing Authorisation in the European Union
• Practical experience and best practice – the CHMP rapporteur’s view
• Success and risk factors in the Centralised Procedure – an ex-regulator viewpoint
• A global perspective on marketing authorisation procedures - EMEA/FDA differences and how these affect innovation

• Advanced Therapy Medicinal Products /CAT
• Experience of the implementation/planned activities
• The CAT and challenges with Advanced Therapies
• Industry implications

• Medical Products Agency - Sweden
• An introduction to the activities of the Swedish Medical Products Agency (MPA)

Speakers-afternoon

• Steffen Thirstrup – Lægemiddelstyrelsen (Danish Medicines Agency), Denmark
• Markku Toivonen - NDA Regulatory Science Ltd
• Carrol Markus - PAREXEL Consulting, UK
• Patrick Celis – Pre-Authorisation Unit, EMEA
• Christian Schneider - Federal Agency for Sera and Vaccines, Paul-Ehrlich-Institut, Germany
• Wilfried Dalemans –Tigenix, Belgium