戻る Agenda
International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation
Session Chair(s)
Michael Berntgen, PHD
Head of Scientific Evidence Generation
European Medicines Agency, Netherlands
The introduction of innovation into healthcare systems requires decision making based on an increasingly complex and diverse evidence. This international panel of regulators and HTAs will discuss perspectives for “universal clinical evidence”.
Learning Objective : Contrast principles for different types of decision making to facilitate introduction of innovative medicines;Translate evidence requirements for different types of decision making(regulatory, HTA, payers and reimbursement); Apply the understanding of multi-dimensional decisions on universal evidence generation plan value versus.
Speaker(s)
Getting the Universal Evidence We Need for Decisions on Innoivation: Perspectives From a Regulator
Michael Berntgen, PHD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
Getting the Universal Evidence We Need for Decisions on Innovations: Perspective From an HTA Agency
Michelle Mujoomdar, PHD
Canadian Agency for Drugs and Technologies in Health (CADTH) , Canada
Director, Scientific Affairs, Evidence Standards
Panelist
Guido Rasi, MD
Tor Vergata University of Rome, Italy
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology
Panelist
Pierre Sabourin, MBA
Health Canada, Canada
Assistant Deputy Minister, Health Products and Food Branch
Panelist
Peter W. Marks, MD, PHD
DIA Fellow, United States
Panelist
Niklas Hedberg, MPHARM
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
HTACG Co-Chair & Chief Pharmacist