programme
09.30 Registration and welcome coffee ◼ Zaide Frias, Head of Human Medicines Evalua-
tion Division, European Medicines Agency (EMA)
10.15 Opening of the conference ◼ Françoise Schlemmer, Director, The European
Association of Medical Devices Notified Bodies
10.30 - 12.20 Session 1 (TEAM-NB)
◼ Oliver Bisazza, Director, Regulations & Industrial
Digital transformation of regulatory science and Policy, MedTech Europe
healthcare ◼ Maud Perrudin, Deputy Director General, AESGP
Keywords: digital single market, eHealth, eProduct 15.00 - 15.30 Coffee/Tea Break
information, pharmacovigilance, real world evidence
15.30 - 17.00 Session 3
◼ Guido Rasi, Executive Director, European Medi-
cines Agency (EMA) 10 years since the first centralised switch. What
◼ Andrzej Rys, Director, Health Systems, Medical have we learnt?
Products and Innovation, Directorate-General
Health and Food Safety, European Commission Keywords: centralised procedure, non-prescription
◼ Karl Broich, Chair, EU Telematics Management medicines, self-care, access, innovation, switch
Board; Director General, Federal Institute for
Drugs and Medical Devices (BfArM), Germany ◼ Prof. Claudio Jommi, Affiliate Professor of
◼ César Hernández, Head of the Department of Government, Health and Not for Profit at SDA
Medicines for Human Use, National Agency for Bocconi School of Management
Medicines and Medical Devices (AEMPS), Spain ◼ Ilaria Passarani, Secretary General, PGEU
◼ Sabine Straus, Chair of the EMA Pharmacovigi- ◼ Gabriella Grippaudo, Senior Director Regulatory
lance Risk Assessment Committee (PRAC); Head & Medical Affairs EMEA, Pfizer Consumer
of Pharmacovigilance, Medicines Evaluation Healthcare
Board, the Netherlands ◼ Helene Guillard, Global Rx-to-OTC Switch Direc-
◼ Giovanna Ferrari, Regional Labeling Lead, Inter- tor, HRA Pharma
national Labeling Group ◼ Zaide Frias, Head of Human Medicines Evalua-
◼ Jurate Svarcaite, Director General, AESGP tion Division, European Medicines Agency (EMA)
◼ Christelle Anquez-Traxler, Regulatory and
12.00 - 13.30 Lunch Scientific Affairs Manager, AESGP
Implementation of the Medical Devices Regula- Conclusions by Hugo Hurts, Executive Director,
tion Dutch Medicines Evaluation Board (MEB), and Birgit
Schuhbauer, AESGP President and Global Vice-
Keywords: substance-based medical devices, MDR President strategic marketing OTC, Johnson & John-
implementation, Notified Bodies son