Conference Agenda

Monday, 28 October 2019

08:00-08:45	Registration
08:45-09:00	Welcome and Opening of the Conference Conference Chair: Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK
09:00-09:45	Implementation of the New Regulations: State of the Play Erik Hansson, Deputy Head of Unit, Health Technology and Cosmetics, DG GROW, European Commission, Belgium
09:45-10:30	View of a Notified Body on the MDR Implementation Steps Bassil Akra, Vice-President, TÜV SÜD Product Service, Germany
10:30-11:00	Coffee Break, Networking and Visit the Exhibition
11:00-11:45	Designation of Notified Bodies: State of Play Françoise Schlemmer, Director, Team-NB, Belgium
11:45-12:30	Seven Months to Go: Are Recent and Ongoing Developments Enough? Amanda Maxwell, Medtech Regulatory Affairs Editor, Medtech Insight, Informa Healthcare, UK
12:30-13:30 13:30-14:00	Lunch Break, Networking and Visit the Exhibition One-To-One Meeting with Speakers
14:00-14:45	The Knowns and the Unknowns until May 2020 - What to Expect and What not to Expect, and How to Plan for it from a Legal Perspective Erik Vollebregt, Partner, Axon Lawyers, The Netherlands
14:45-15:30	Post-Market Surveillance - A New Concept OR a Great Misunderstanding / The Importance of Post Market Surveillance Ludger Möller, EAAR Vice-Chairman, President, Medical Device Safety Service, Germany
15:30-16:00	Coffee Break, Networking and Visit the Exhibition
16:00-16:45	Vigilance - Are There New Reporting Requirements? How is the New Market Surveillance Being Applied? Ludger Möller, EAAR Vice-Chairman, President, Medical Device Safety Service, Germany
16:45-17:30	The Role of GS1 as UDI Issuing Agency Geraldine Lissalde-Bonnet, Director, Public Policy-Healthcare, GS1, Belgium
17:30-18:15	Impact of the MD/IVD-Regulations on Quality Management Systems Kirsten Van Garsse, Regulatory Affairs Manager, Qarad, Belgium
18:15	End of Day One

Tuesday, 29 October 2019

08:15-09:00	Registration
09:00-09:45	Challenges Arising from the New Concepts in the Regulations Relating to Scope, Classification and General Safety and Performance Requirements Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK
09:45-10:30	Practical Aspects of Clinical Evaluation: Before and After CE Marking under the MDR Sarah Sorrel, EAAR Member of the Board, President, Medpass International, France
10:30-11:00	Coffee Break, Networking and Visit the Exhibition
11:00-11:45	Eudamed and UDI, a Curse in Disguise Ronald Boumans, EAAR Member of the Board, Senior Global Regulatory Consultant, Emergo, The Netherlands
11:45-12:30	Major Regulatory Compliance Challenges for the Industry Dario Pirovano, Senior Regulatory Adviser, MedTech Europe, Belgium
12:30-13:30 13:00-13:30	Lunch Break, Networking and Visit the Exhibition One-To-One Meeting with Speakers
13:30-14:15	What can we Expect from the MDR Autorised Representative? Sandra Ferretti, EAAR Member of the Board, Chief Compliance Officer, Obelis, Belgium
14:15-15:00	Special IVD Issues Kirsten Van Garsse, Regulatory Affairs Manager, Qarad, Belgium
15:00-15:45	Medical Device Software in the European Union Robert Ginsberg, EAAR Member of the Board, Chairman of the Board, QAdvis, Sweden
15:45-16:15	Coffee Break, Networking and Visit the Exhibition
16:15-17:00	Conflict Between Economic Operators Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK
17:00-17:30	Panel Discussion: Will it be a Hard of Soft Landing? For the Many of the Few? All Speakers
17:30	Conference Closing Mika Reinikainen, EAAR Chairman, Managing Director, Abnovo, UK