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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)
Michael Berntgen, PhD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
Getting the Universal Evidence We Need for Decisions on Innoivation: Perspectives From a Regulator
Michelle Mujoomdar, PhD
Director, Scientific Affairs, Evidence Standards, Canadian Agency for Drugs and Technologies in Health (CADTH) , Canada
Getting the Universal Evidence We Need for Decisions on Innovations: Perspective From an HTA Agency
Guido Rasi, MD
Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology, Tor Vergata University of Rome, Italy
Panelist
Pierre Sabourin, MBA
Assistant Deputy Minister, Health Products and Food Branch, Health Canada, Canada
Panelist
Peter Marks, MD, PhD
Senior Vice President, Molecule Discovery and Head of Infectious Disease, Eli Lilly and Company, United States
Panelist
Niklas Hedberg, MPharm
HTACG Co-Chair & Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Panelist
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