Head of Global Regulatory Affairs, Medical and Pharmacovigilance
Accino, Switzerland
Leader, chair and speaker
Tomáš Boráň
Director of the Marketing Authorisation Section
SÚKL, Czech Republic
Speaker
Nataliya Burlakina
GMP Inspector
State Institute of Drugs and Good Practices, Russian Federation
Executive Director
Czech Association of Pharmaceutical Companies, Czech Republic
Chief Regulatory Officer
Aurion Biotech, USA
Executive Director
European Medicines Agency (EMA)
HM3: The evolution of the EMA-EUnetHTA collaboration - bridging of decision makers | 22 September 2021
Senior Director, Global Regulatory Affairs
BMS, USA
Head of Product Development Scientific Support Department
European Medicines Agency (EMA)
Chief Pharmacist
EUnetHTA / TLV, Sweden
Speaker
Flora Giorgio
Deputy Head of Unit B6, DG Sante
European Commission
HM4: Real world evidence in regulatory decision-making | 22 September 2021
Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland
Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research
U.S. Food and Drug Administration, USA
Regulatory Innovation Lead for RWE & Data Science, Global Regulatory Strategy & Policy
BMS, USA
Speaker
Xavier Kurz
Head of Data Analytics
European Medicines Agency (EMA)
HM5: Reliance, worksharing and recognition as 21st century regulatory tools | 22 September 2021
Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland
Deputy Director Integrated Development (Lead for Global Regulatory Systems Initiatives)
Bill & Melinda Gates Foundation
Principal International Affairs Officer
European Medicines Agency
Vice President, Head of Oncology, Global Regulatory Strategy & Policy
BMS, US
TOPRA Annual Lecture: From ‘knocking on the door’ to co-creation: 25 years of patient engagement in R&D | 23 September 2021
Therapeutic Development Director
EURORDIS France
HM6: Clinical trials of the future – patient oriented and digitally connected | 23 September 2021
Director EU Global Regulatory and Scientific Policy
Merck BV, the Netherlands
Senior Director, Global Regulatory Affairs
BMS, USA
Director Clinical Trial Execution, Clinical Delivery Unit
Merck Healthcare, Germany
Senior Vice President, Scientific & Clinical Affairs Head
Icon, USA
Speaker
Fergus Sweeney
Head, Clinical Studies and Manufacturing Taskforce
European Medicines Agency (EMA)
Panellist
Ann-Marie Janson Lang
CTFG co-chair
MPA, Sweden
HM7: Regulatory progress in delivering on the promise of ATMPs | 23 September 2021
Leader, chair and panellist
Tomáš Boráň
Director of the Marketing Authorisation Section
SUKL, Czech Republic
Chief Regulatory Officer
Aurion Biotech, USA
Speaker
Wilson W. Bryan
Director of the Office of Tissues and Advanced Therapies
Center for Biologics Evaluation and Research (FDA), USA
Head of Advanced Therapies
European Medicines Agency (EMA)
VP Regulatory Science
Orchard Therapeutics
Speaker
Angelo Loris Brunetta
Board member of Thalassaemia International Federation and former member of the Committee for Orphan Medicinal Products (COMP), Italy
HM8: Enhancing dialogue to foster innovation | 24 September 2021
Director EU Global Regulatory and Scientific Policy
Merck BV, the Netherlands
Senior Director, Global Regulatory Affairs
BMS, USA
Speaker
Iordanis Gravanis
Head of Scientific Advice
European Medicines Agency (EMA)
Senior Director Global Regualtory and Scientific Policy Europe
Merck Healthcare, Germany
HM9MD5: Innovation in drug-device combinations – how to navigate a complex regulatory environment? | 24 September 2021
Department Manager, Regulatory Affairs NextGen Drug-device
Novo Nordisk, Denmark
Speaker
Christelle Bouygues
Regulatory Affairs Officer
European Medicines Agency (EMA)
Associate Director for Policy and Product Classification Officer
FDA, USA
Global Head Device Development & Commercialization
Novartis, Switzerland
Panellist
Nada Alkhayat
Policy Officer – Medical Devices, Unit B6, DG Sante
European Commission