5th TOPRA Annual Symposium

Why attend the TOPRA Symposia?

Hear the latest regulatory intelligence on key issues in Regulatory Affairs from our international speaker panel.
Collect new ideas to help you and your business meet the challenges and maximise the opportunities offered by the current regulatory environment.
Maintain and develop your network of industry and agency contacts

Speakers include:

• Philippe Auby – Lundbeck SAS, France
• Janos Borvendeg – National Institute of Pharmacy – Hungary
• Gabriele Eibenstein – BfArM, Germany
• Stefan Fuehring – European Commission
• Thomas Heynisch – European Commission
• Peter Karolyi – EMEA
• Mária Kenéz – EGIS Pharmaceuticals PLC, Hungary
• Xavier Luria Oller – EMEA
• Tamas Paal – Professor of Regulatory Affairs, Hungary
• Kristin Raudsepp – Ravimiamet, Estonia
• Agnes Saint Raymond – EMEA
• Norman R. Schmuff – FDA, USA
• Ondrej Slanar – SUKL, Czech Republic
• Ilia Slavov – HURAS, Hungary
• Martin Terberger – European Commission
• Jean-Hugues Trouvin – EMEA BWP, Afssaps, France
• Daniela Vasilescu – National Medicines Agency, Romania
• Martina Weise – BfArM and V Chair EMEA Biosimilars WP, Germany
• Gergely Zajzon – National Institute of Pharmacy, Hungary

Plus other speakers from National Competent Authorities. EMEA, European Commission, Industry and other health care related bodies invited.

Programme includes:

• East and Central European countries: active partners in European regulatory affairs
• Mutual Recognition Procedure/ Decentralised Procedure
• Centralised Procedure
• Chemistry Manufacturing and Controls (CMC) – variations and post approval changes
• Pharmacovigilance – Today’s risks influence our common future
• Three parallel break out sessions covering:
1. Biotechnology – Regulating a moving frontier
2. The eCTD – getting it right first time and every time
3. Regulatory Careers
• Paediatrics
• Hot topics from the European Commission
• Closing Remarks

Please note that the programme could be subject to change.

This conference contributes 14 hours of training to your LLL (sometimes known as Continuing Professional Development) and will enhance your Regulatory Skills relevant in the areas of human and veterinary medicines.