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Session 8: Interface between Authorisation and HTA
Session Chair(s)
Inka Heikkinen, MBA, MS, MSc
Director, Global Regulatory Policy
MSD, 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)
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
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
ZIN/MEB Pilot collaboration – Lessons learned & Link to Reg Science
Pauline Pasman
Dutch National Health Care Institute (ZIN), Netherlands
Project leader MEB-ZIN
Interface between Authorisation and HTA
Michael Berntgen, PhD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
Panel discussion with Q&A
Wim Goettsch, PhD, MSc
Dutch National Health Care Institute (ZIN), Netherlands
Special Advisor HTA
Panel discussion with Q&A
Mihai Rotaru, MA
EFPIA, Belgium
Senior Manager Market Access
Panel discussion with Q&A
Ansgar Hebborn, PhD, MBA
F. Hoffmann-La Roche AG, Switzerland
Head - Access Policy Affairs Europe
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