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Regulatory Access Pathways to Facilitate Early Access and HTA Synergies
Session Chair(s)
Indranil Bagchi, PHD, MSC
Global Head, Pricing & Market Access, GSK, United States
Jordi Llinares Garcia, MS
Head of Research and Innovation, European Medicines Agency, Netherlands
In this session we will discuss the experience of early access pathways from a regulatory point of view and how these instruments are experienced by industry stakeholders. In addition, the point of view of HTA agencies, in particular HTA uptake of the outcomes of these instruments and how the remaining uncertainties impact HTA decisions will also be discussed. The influence/opportunity of current initiatives such as parallel advice and late dialogues with regulators can be explored in this context.
Speaker(s)
François Meyer, MD
Advisor to the President, International Affairs, French National Authority for Health (HAS), France
HTA Body View on Early Access Experiences
Sabine Haubenreisser, PHD, MSC
Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
EMA View
Simon Bennett, MS
Director, EU Regulatory Policy, Biogen, United Kingdom
Faster Regulatory Approvals and Better Access for Patients – Progress towards Squaring the Circle
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