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Virtual Event

Sep 28, 2020 2:00 PM - Sep 30, 2020 6:00 PM

(Central Europe Standard Time)

4051 Basel, Switzerland

Regulatory Science Forum

Session 8: Interface between Authorisation and HTA

Session Chair(s)

Inka  Heikkinen, MBA, MSc

Inka Heikkinen, MBA, MSc

Regulatory Policy Lead

Lundbeck, Denmark

Regulatory and HTA/payers underpin their respective assessment and decision-making on increasing novel evidence sources. This session will discuss the interface and gaps between authorisation and reimbursement and the consequences for the predictability of decision making. So that patients can gain more timely access to beneficial treatments

Speaker(s)

Rick  Vreman

Decision-making under uncertainty: comparing regulatory and health technology assessment reviews of medicines in the US and Europe

Rick Vreman

Roche, Netherlands

Patient Access Manager

Magdalini  Papadaki, PhD, MBA, MSc

Managing product approval and reimbursement requirements from the developer’s side, current challenges and future opportunities

Magdalini Papadaki, PhD, MBA, MSc

MSD, United Kingdom

Director, Regulatory Affairs International

Pauline  Pasman

ZIN/MEB Pilot collaboration – Lessons learned & Link to Reg Science

Pauline Pasman

Dutch National Health Care Institute (ZIN), Netherlands

Project leader MEB-ZIN

Michael  Berntgen, PhD

Interface between Authorisation and HTA

Michael Berntgen, PhD

European Medicines Agency, Netherlands

Head of Scientific Evidence Generation

Wim  Goettsch, PhD, MSc

Panel discussion with Q&A

Wim Goettsch, PhD, MSc

Dutch National Health Care Institute (ZIN), Netherlands

Special Advisor HTA

Mihai  Rotaru, MA

Panel discussion with Q&A

Mihai Rotaru, MA

EFPIA, Belgium

Senior Manager Market Access

Ansgar  Hebborn, PhD, MBA

Panel discussion with Q&A

Ansgar Hebborn, PhD, MBA

F. Hoffmann-La Roche AG, Switzerland

Head - Access Policy Affairs Europe

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