HM1: A Decade of Innovative Clinical Trials – What Have We Learned and Where Are We Going? | 17 October 2022
Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland
Director EU Global Regulatory and Scientific Policy
Merck BV, the Netherlands
Speaker
Theodor Framke
Seconded National Expert
European Medicines Agency (EMA)
Regulatory Policy Executive Director
Novartis, Switzerland
Alternate Member, Scientific Advice Working Party at European Medicines Agency
Norwegian Medicines Agency, Norway
Clinical Assessor
Federal Agency for Medicines and Health Products (FAMHP), Belgium
PV and CT Safety Assessor
Austrian Medicines and Medical Devices Agency (AGES), Austria
HM2: Are Expedited Programs Delivering on the Promise to Accelerate Drug Development and Patient Access? | 17 October 2022
Director, International Regulatory Policy & Intelligence
United Kingdom
Senior Director, Global Regulatory Affairs
BMS, USA
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 (FDA), USA
Deputy Director, Innovation Accelerator and Regulatory Science
MHRA, United Kingdom
Vice President – International Regulatory Strategy
Vertex, United Kingdom
PS1: Implementation of the CTR | 17 October 2022
Chair
Christopher Price
Senior Manager, Global Regulatory Oncology
Merck, Germany
CTIS Business Expert
European Medicines Agency (EMA)
PV und CT Safety Assessor
Austrian Medicines and Medical Devices Agency (AGES), Austria
Executive Director
Transperfect, France
HM3: Lessons Learned and Strategic Priorities | 17 October 2022
Expert Consultant,
NDA Partners, USA
Leader and chair
Sabine Haubenreisser
Principal Scientific Administrator, Stakeholders and Communication
European Medicines Agency (EMA)
Commissioner of Food and Drugs
U.S. Food and Drug Administration (FDA), USA
Executive Director
European Medicines Agency (EMA)
Head of Austrian Medicines and Medical Devices Agency (AGES)
Austria
HM4: Assessing the Value of Innovative Therapies: Trends, Challenges, and Learnings | 18 October 2022
Senior Director, Global Regulatory Affairs
BMS, USA
Director
Austrian Institute for Health Technology Assessment (AIHTA), Austria
Head of Scientific Evidence Generation
European Medicines Agency (EMA)
Senior Manager, HTA programme and Strategic Partnership
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
TOPRA Annual Lecture: Access to Medicines Beyond Europe – The Potential of Reliance | 18 October 2022
Assistant Director General
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
HM5: Digital Health Opportunities and Advancements in Healthcare | 18 October 2022
Department Affairs Director, Regulatory Affairs Digital Health
Novo Nordisk, Denmark
Head Digital Health and Devices
Merck, Switzerland
Vice President Digital Health
Novo Nordisk, Denmark
Scientific Administrator
European Medicines Agency (EMA)
Head of IT
Austrian Medicines and Medical Devices Agency (AGES), Austria
HM6: Innovation in Regulatory Science – The Path from Data to Evidence and the Promise to Streamline the Regulatory Lifecycle | 18 October 2022
Nonclinical and Biological Assessor
Austrian Agency for Health and Food Safety (AGES), Austria
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 (FDA), USA
Director Global Regulatory Policy and Intelligence
Abbvie, Ireland
VP of Regulatory Innovation
Accumulus Synergy, USA
Biostatistician, Senior Expert
Austrian Medicines and Medical Devices Agency (AGES), Austria
Head of Digital Change
European Medicines Agency (EMA)
HM7: Are Patients Still the Missing Piece in the Global Drug Development Puzzle? | 19 October 2022
Director EU Global Regulatory and Scientific Policy
Merck BV, the Netherlands
Director, International Regulatory Affairs
Blueprint Medicines, Switzerland
Patient representative, NF Patients United
EUPATI, Austria
Director, Therapeutic Expertise
ICON plc, United Kingdom
Patient Relations
European Medicines Agency (EMA)
Head of Scientific Office
Austrian Medicines and Medical Devices Agency (AGES), Austria
Associate Director Regulatory Affairs
PTC Therapeutics, Switzerland
Speaker
Martina Schuessler-Lenz
Paul-Ehrlich-Institut, Germany
and Chair of the Committee for Advanced Therapies (CAT)
European Medicines Agency (EMA)
Senior Director, Regulatory Affairs
PTC Therapeutics, France
Speaker
Frank-Ulrich Fricke
Health Economist
University of Nurnberg, Germany
Scientific Administrator, Committee for Advanced Therapies (CAT)
European Medicines Agency (EMA)
Panellist
Silke Dorner
Assessor
Austrian Medicines and Medical Devices Agency (AGES), Austria
HM9: Strategy Under Uncertainty – Improving the Odds of Regulatory Success | 19 October 2022
Expert Consultant
NDA Partners, USA
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
Senior Director, Global Regulatory Affairs
BMS, USA