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Session 8: Interface between Authorisation and HTA
Session Chair(s)
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)
Decision-making under uncertainty: comparing regulatory and health technology assessment reviews of medicines in the US and Europe
Rick Vreman
Patient Access Manager, Roche, Netherlands
Managing product approval and reimbursement requirements from the developer’s side, current challenges and future opportunities
Magdalini Papadaki, PhD, MBA, MSc
Executive Director, Regulatory Affairs International, MSD, United Kingdom
ZIN/MEB Pilot collaboration – Lessons learned & Link to Reg Science
Pauline Pasman
Project leader MEB-ZIN, Dutch National Health Care Institute (ZIN), Netherlands
Interface between Authorisation and HTA
Michael Berntgen, PhD
Head of Scientific Evidence Generation, European Medicines Agency, Netherlands
Panel discussion with Q&A
Wim Goettsch, PhD, MSc
Special Advisor HTA, Dutch National Health Care Institute (ZIN), Netherlands
Panel discussion with Q&A
Mihai Rotaru, MA
Senior Manager Market Access, EFPIA, Belgium
Panel discussion with Q&A
Ansgar Hebborn, PhD, MBA
Head - Access Policy Affairs Europe, F. Hoffmann-La Roche AG, Switzerland
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