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Regulatory Science Forum


Session 8: Interface between Authorisation and HTA

Session Chair(s)

Inka  Heikkinen, MBA, MS, MSc

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)

Rick  Vreman

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
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

  • Director, Regulatory Affairs International
  • MSD, United Kingdom
Pauline  Pasman

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

Pauline Pasman

  • Project leader MEB-ZIN
  • Dutch National Health Care Institute (ZIN), Netherlands
Michael  Berntgen, PhD

Interface between Authorisation and HTA

Michael Berntgen, PhD

  • Head of Scientific Evidence Generation
  • European Medicines Agency, Netherlands
Wim  Goettsch, PhD, MSc

Panel discussion with Q&A

Wim Goettsch, PhD, MSc

  • Special Advisor HTA
  • Dutch National Health Care Institute (ZIN), Netherlands
Mihai  Rotaru, MA

Panel discussion with Q&A

Mihai Rotaru, MA

  • Senior Manager Market Access
  • EFPIA, Belgium
Ansgar  Hebborn, PhD, MBA

Panel discussion with Q&A

Ansgar Hebborn, PhD, MBA

  • Head - Access Policy Affairs Europe
  • F. Hoffmann-La Roche AG, Switzerland

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