CEO and Co-Owner QUNIQUE - Germany
Panellist Session: MD3 - General update on MDR and IVDR When: 7 October | 12:30 – 14:00 BST (GMT+1)
Senior Director Regulatory Strategy and Advocacy Abbott Laboratories - Belgium
Topic: Initial experience of post-market surveillance under the MDR from an industry perspective Session: MD2 - Post-market surveillance When: 7 October | 9:00 – 10:30 BST (GMT+1)
Topic: Notified Body expectations for performance evaluation review Session: IVD5 - Clinical evidence for IVDs When: 8 October | 14:15 – 15:45 BST (GMT+1)
Senior Director Regulatory Affairs - Medical Devices & Combination Products AstraZeneca - UK
Session: PS1- Combined products - Drugs, devices, IVDs, software - how to regulate and innovate? When: 6 October | 10:15 – 11:45 BST (GMT+1)
Software Focus Group Chair COCIR & Philips - Belgium Topic: Qualification of medical device software Session: MD5 - Software as a medical device When: 8 October | 12:30 – 14:00 BST (GMT+1)
Head of Clinical Investigations & Unmet Medical Need Unit Federal Agency for Medicines and Health Products (FAMHP) - Belgium
Topic: Post market requirements in the MDR; a Competent Authority perspective Session: MD2 - Post-market surveillance When: 7 October | 9:00 – 10:30
Session: MD4 - Clinical evidence, an evident challenge When: 8 October | 9:00 – 10:30 BST (GMT+1)
Rutger Flink CEO/Founder PulmoTech BV - the Netherlands Session: MD4 - Clinical evidence: an evident challenge When: 8 October | 9:00 – 10:30 BST (GMT+1)
Professor of Pharmaceutics King’s College London - UK
Deputy Head - Health Technology and Cosmetics Unit DG GROW - European Commission
Principal Consultant Commutateur Advocacy Communication - France
Team lead Non-active Devices and Article 117 MDR TÜV SÜD - Germany
Session: PS1: Combined products - Drugs, devices, IVDs, software - how to regulate and innovate? When: 6 October | 10:15 – 11:45 BST (GMT+1)
Medical Devices Quality Assessor Federal Agency for Medicines and Health Products (FAMHP) - Belgium Topic: Perspective of a national CA to support innovation of medical products Session: HM5MD1 - Innovation and regulation at the interface of medicines, devices and companion diagnostics When: 6 October | 15:00 – 16:30 BST (GMT+1)
Technical Specialist and Scheme Manager BSI - UK Topic: Innovative borderline products challenging current regulations Session: HM5MD1 - Innovation at the interface of medicines, devices and companion diagnostics When: 6 October | 15:00 – 16:30 BST (GMT+1)
Clinical Evaluation Lead Dedalus HealthCare - Belgium
Topic: Clinical evaluation of medical device software Session: MD5 - Software as a medical device When: 8 October | 12:30 – 14:00 BST (GMT+1)
Director, Medical Writing Avania Clinical - the Netherlands
Panellist
Session: MD4: Clinical evidence: an evident challenge When: 8 October | 9:00 – 10:30
General Director of DG Post-Authorization Federal Agency for Medicines and Health Products (FAMHP), Belgium
Topic: Implementing the IVDR - a national health authority perspective Session: IVD4 - Preparing for the IVDR When: 8 October | 10:45 –12:15 BST (GMT+1)
Senior Manager Regulatory Affairs, CMC Medical Devices & Combination Products Biogen - United States
Head of Notified Body SGS - Belgium
Topic: Post-market requirements in the MDR; a Notified Bodies perspective Session: MD2 - Post-market surveillance When: 7 October | 9:00 – 10:30 BST (GMT+1)
Senior Supervision Officer Dutch Data Protection Authority - the Netherlands Session: MD4 - Clinical evidence: an evident challenge When: 8 October | 9:00 – 10:30 BST (GMT+1)
Valérie Nys Program Manager Federal Agency for Medicines and Health Products (FAMHP) -Belgium Topic: Competent Authority perspective Session: MD3 - General update on MDR and IVDR When: 7 October | 12:30 – 14:00 BST (GMT+1)
Scientific Administrator, Regulatory Affairs Office European Medicines Agency (EMA) Topic: Update from EMA on regulatory strategy initiatives Session: HM5MD1 - Innovation and regulation at the interface of medicines, devices and companion diagnostics When: 6 October | 15:00 – 16:30 BST (GMT+1)
European Lead Digital Therapeutics Alliance
Panellist Session: PS1- Combined products - Drugs, devices, IVDs, software - how to regulate and innovate? When: 6 October | 10:15 – 11:45 BST (GMT+1)
Head of In Vitro Diagnostics & Principal Consultant Qserve Group UK
Topic: Go with the flow for performance evaluation Session: IVD5 - Clinical evidence for IVDs When: 8 October | 14:15 – 15:45 BST (GMT+1)
Vice President MHS Global IVD TÜV SÜD - Japan
Topic: The IVD-R challenges from a Notified Body point of view Session: IVD4 - Preparing for the IVDR When: 8 October | 10:45 – 12:15 BST (GMT+1)
Senior Consultant / Medical Writer Biophoenix Ltd - UK Topic: Applying lessons from clinical evaluations of medical devices to IVDs Session: IVD5 - Clinical evidence for IVDs When: 8 October | 14:15 – 15:45 BST (GMT+1)
Chair Global Medical Device Nomenclature Agency - UK
Session: PS - Combined products - Drugs, devices, IVDs, software - how to regulate and innovate? When: 6 October | 10:15 – 11:45 BST (GMT+1)
Martin Witte Global Director Focus Team, Active Implantable & Cardiovascular Devices TÜV SÜD Product Service - Germany Topic: Notified Body perspective on MDR and IVDR Session: MD3 - General update on MDR and IVDR When: 7 October | 12:30 – 14:00 BST (GMT+1)
Head of Regulatory Affairs, North America Coalition for Epidemic Preparedness Innovations (CEPI) - USA
Topic: Epidemic preparedness Session: Annual Lecture When: 29 September | 14:30 – 15:30 BST (GMT+1)
Senior Manager Regulations & Industrial Policy MedTech Europe - Belgium Topic: Industry challenges and learnings so far Session: MD3 - General update on MDR and IVDR When: 7 October | 12:30 - 14:00 BST (GMT+1)
Head of Global Regulatory Affairs and Pharmacovigilance Kora Healthcare - Ireland
Session Leader and Chair: MD2 - Post-market surveillance When: 7 October | 9:00 – 10:30 BST (GMT+1)
Project Manager and Data Protection Officer Avania Clinical - the Netherlands Session Leader and Chair: MD4 - Clinical evidence: an evident challenge When: 8 October | 9:00 – 10:30 BST (GMT+1)
Software Focus Group Chair COCIR & Philips - Belgium Session Leader and Chair: MD5 - Software as a medical device When: 8 October | 12:30 – 14:00 BST (GMT+1)
EU Editor International Pharmaceutical Quality Publications - Sweden
Session Leader and Chair: HM5MD1 - Innovation at the interface of medicines, devices and companion diagnostics When: 6 October | 15:00 – 16:30 BST (GMT+1)
CEO, Regulatory Affairs & Quality Assurance Methra Uppsala - Sweden
Session Leader and Chair: MD3 - General update on MDR and IVDR When: 7 October | 12:30 – 14:00 BST (GMT+1)
Scientific Administrator, Regulatory Affairs Office European Medicines Agency (EMA) Session Leader: PS1 - Combined products - Drugs, devices, tissues, IVDs, software - how to regulate and innovate? When: 6 October | 15:00 – 16:30 BST (GMT+1)
Co-owner & Principal Consultant QUARAD - Belgium
Session Leader and Chair: IVD4 - Preparing for the IVDR When: 8 October | 9:00 – 10:30 BST (GMT+1)
Managing Director Biophoenix Ltd - UK Session Leader and Chair: IVD5 - Clinical evidence for IVDs When: 8 October | 14:15 – 15:45 BST (GMT+1)