Team Lead, Regulatory Convergence and Networks, Unit Head a.i., Regulation and Safety World Health Organisation (WHO)
Session: HM2 - Expansion of regulatory innovation in other markets When: 5 October | 12:30 – 14:00 BST (GMT+1)
Director EU Global Regulatory and Scientific Policy Merck BV - the Netherlands Topic: Capturing the patient voice on benefits and risks of medicinal products Session: HM8 - Patient centricity in regulatory affairs and involvement in evidence generation When: 7 October | 14:15 – 15:45 BST (GMT+1)
Expert Patient Advocate - Board Member Patient Expert Committee - Belgium Topic: The patient experience of patient-centric research Session: HM8 - Patient centricity in regulatory affairs and involvement in evidence generation When: 7 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)
Chief Executive Officer Federal Agency for Medicines and Health Products (FAMHP) - Belgium Session: HM1: Driving the healthcare regulatory system into the future When: 5 October | 9:00 – 10:30 BST (GMT+1)
Policy Officer, Unit B5, DG Sante European Commission
Session: HM3 - Orphan and paediatric policy updates When: 5 October | 16:00 – 17:30 BST (GMT+1)
Director, Regulatory, Drug development and Manufacturing European Federation of Pharmaceutical Industries (EFPIA) - Belgium
Session: HM1: Driving the healthcare regulatory system into the future When: 5 October | 9:00 – 10:30 BST (GMT+1)
Professor of Pharmaceutics King’s College London - UK
Regulatory Affairs European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) - Belgium
Session: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning? When: 7 October | 10:45 – 12:15 BST (GMT+1)
Topic: Review of joint production by EUnetHTA and opportunities for development planning Session: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning? When: 7 October | 10:45 – 12:15 BST (GMT+1)
Clinical Assessor Medical Evaluation Board (MEB) - the Netherlands
Topic: Learnings from the exchange between EMA and HTA bodies at market entry and in view of PLEG planning Session: HM7 - Looking at decision-making by regulators and HTAs: what can we learn for prospective evidence planning? When: 7 October | 10:45 – 12:15 BST (GMT+1)
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)
CTFG co-chair Medical Products Agency (MPA) - Sweden Session: HM6 - Innovation in clinical trials When: 6 October | 16:45 – 18:15 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)
Principal, Strategic Consultant Diane K Jorkasky Consulting - USA Topic: Challenges and opportunities in clinical trials' innovation: a physician voice with an industry perspective Session: HM6 - Innovation in clinical trials When: 6 October | 16:45 – 18:15 BST (GMT+1)
MHLW/PMDA Liaison Official, International Affairs Division European Medicines Agency Session: HM2 - Expansion of regulatory Innovation in other markets When: 5 October | 12:30 – 14:00 BST (GMT+1)
Thomas Kühler Head Global Regulatory Science & Policy EU/AMESA Sanofi - France Session: HM2 - Expansion of regulatory Innovation in other markets When: 5 October | 12:30 – 14:00 BST (GMT+1)
Christophe Lahorte Head of National Innovation Office & Scientific-Technical Advice Unit Federal Agency for Medicines and Health Products (FAMHP) - Belgium Topic: Engaging with patients and patient representatives during scientific advice and early clinical development Session: HM8 - Patient-centricity in regulatory affairs and involvement in evidence generation When: 7 October | 14:15 – 15:45 BST (GMT+1)
Patients and Consumers Liaison European Medicines Agency (EMA)
Panellist Session: HM8 - Patient-centricity in regulatory affairs and involvement in evidence generation When: 7 October | 14:15 – 15:45 BST (GMT+1)
Senior Manager Regulatory Affairs, CMC Medical Devices & Combination Products Biogen - United States
Topic: Global development of IVDs, including companion diagnostics for personalised medicine Session: HM5MD1 - Innovation at the interface of medicines, devices and companion diagnostics When: 6 October | 15:00 – 16:30 BST (GMT+1)
Paediatric Committee (PDCO) chair Universitair Ziekenhuis Antwerpen - Belgium
Scientific Affairs Manager Health Products Regulatory Authority (HPRA) - Ireland
Session: HM4 - Regulatory support to research and development When: 6 October | 10:15 –11:45 BST (GMT+1)
Industry Stakeholder Liaison, European Medicines Agency (EMA) European Medicines Agency (EMA)
Panellist Session: HM2 - Expansion of regulatory innovation in other markets When: 5 October | 12:30 – 14:00 BST (GMT+1)
Executive Director European Medicines Agency (EMA) Session: HM1: Driving the healthcare regulatory system into the future When: 5 October | 9:00 – 10:30 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)
Director General Danish Medicines Agency (DKMA) - Denmark
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 Unit B5, DG Sante European Commission Session: HM1: Driving the healthcare regulatory system into the future When: 5 October | 9:00 – 10:30 BST (GMT+1)
Assessor Clinical Trials and CTFG Co-chair Federal Institute for Drugs and Medicinal Devices (BfArM) - Germany Session: HM6 - Innovation in clinical trials When: 6 October | 16:45 – 18:15 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)
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)
When: 7 October | 10:45 – 12:15 BST (GMT+1)
Director EU Global Regulatory and Scientific Policy Merck BV - the Netherlands Session Leader & Chair: HM8 - Patient-centricity in regulatory affairs and involvement in evidence generation When: 7 October | 14:15 – 15:45 BST (GMT+1)
Global Program Regulatory Manager Novartis - Switzerland Session Leader: HM6 - Innovation in clinical trials When: 6 October | 16:45 – 18:15 BST (GMT+1)
Senior Director, Regulatory Sciences Biogen - United States Session Leader: HM6 - Innovation in clinical trials When: 6 October | 16:45 – 18:15 BST (GMT+1)
Director, Regulatory Science and Chief of Staff, Global Regulatory Affairs Alexion - France Session Leader: HM3 - Orphan and paediatric policy updates When: 5 October | 16:00 – 17:30 BST (GMT+1)
Head of Innovation Task Force European Medicines Agency (EMA)
Session: HM4 - Regulatory support to research and development
When: 6 October | 10:15 – 11:45 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)
Senior Director, Global Regulatory Affairs Bristol-Myers Squibb - United States Session Leader and Chair: HM2 - Expansion of regulatory innovation in other markets When: 5 October | 12:30 – 14:00 BST (GMT+1)
General Director DG PRE authorisation Federal Agency for Medicines and Health Products (FAMHP) - Belgium Session Leader: HM1 - Driving the healthcare regulatory system into the future When: 5 October | 9:00 – 10:30 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)
