Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

International Convergence on Regulatory Review and HTA: Getting the “Universal Evidence” We Need for Decisions on Innovation

Session Chair(s)

Michael  Berntgen, PhD

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

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

Michelle  Mujoomdar, PhD

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

Guido  Rasi, MD

Panelist

Guido Rasi, MD

Tor Vergata University of Rome, Italy

Chairman,Clinical Trial Center of Gemelli Polyclinic Inst; Prof of Microbiology

Pierre  Sabourin, MBA

Panelist

Pierre Sabourin, MBA

Health Canada, Canada

Assistant Deputy Minister, Health Products and Food Branch

Peter W. Marks, MD, PhD

Panelist

Peter W. Marks, MD, PhD

FDA, United States

Director, Center for Biologics Evaluation and Research

Niklas  Hedberg, MPharm

Panelist

Niklas Hedberg, MPharm

Dental and Pharmaceutical Benefits Agency, TLV, Sweden

HTACG Co-Chair & Chief Pharmacist

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.