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Monday, June 15 • 11:00am - 12:00pm
#109 L: International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-541-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Michael Berntgen, PhD


Perspectives From a Regulator
Michael Berntgen, PhD

Planning for Evidence for HTA
Michelle Mujoomdar, PhD

Guido Rasi, MD

Pierre Sabourin, MBA

Peter W. Marks, MD, PhD

Niklas Hedberg, MPharm

avatar for Michael Berntgen

Michael Berntgen

Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
The Scientific Evidence Generation Department aims to support the development of medicines to ensure generation of robust and relevant scientific evidence, also in collaboration with other stakeholders. Activities include the provision of scientific advice & methodology qualification... Read More →
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board; Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Niklas Hedberg is the Chief Pharmacist at the Swedish national governmental authority, the Dental and Pharmaceuticals Benefits Agency (TLV). He is the Chair of the EUnetHTA Executive Board and the TLV lead partner in EUnetHTA WP 3 Evaluation. Niklas has been working with pricing and... Read More →
avatar for Michelle Mujoomdar

Michelle Mujoomdar

Director, Scientific Affairs, Evidence Standards, Canadian Agency for Drugs and Technologies in Health (CADTH)
Dr. Michelle Mujoomdar has held several leadership roles since joining CADTH in 2008. In 2013, Michelle joined CADTH’s Evidence Standards team as Director, Scientific Affairs where she has accountability for the quality of CADTH’s work. In this role, she also has oversight for... Read More →
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →
avatar for Pierre Sabourin

Pierre Sabourin

Assistant Deputy Minister, Health Products and Food Branch, Health Canada, Canada
Pierre Sabourin was appointed Assistant Deputy Minister (ADM) of the Health Products and Food Branch (HPFB) at Health Canada in 2016. The branch plays a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory... Read More →

Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Forum |   12: Value-Access, Forum