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Regulatory Science Forum
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
- Division of Pharmacoepidemiology and Clinical Pharmacology
- Utrecht University, Netherlands
Managing product approval and reimbursement requirements from the developer’s side, current challenges and future opportunities
Magdalini Papadaki, PhD, MBA, MSc
- 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
