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HTA Body View on Early Access Experiences

Can Regulators and HTA Bodies Create Synergies for Patient Access?

Day & Time:
April 18, 2:00PM - 3:15PM (Central Europe Standard Time)

Session Number:

Room Number:


Regulatory Access Pathways to Facilitate Early Access and HTA Synergies

Indranil Bagchi, PhD, MS
SVP and Head, Global Value and Access
Novartis Oncology, United States

Jordi Llinares Garcia, MS
Head of Scientific and Regulatory Management
European Medicines Agency (EMA), United Kingdom

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.

Presentation(s) & Speaker(s):
HTA Body View on Early Access Experiences
François Meyer, MD
Advisor to the President, International Affairs
French National Authority for Health (HAS), France

EMA View
Sabine Haubenreisser, PhD, MSc
Principal Scientific Administrator, International Affairs
European Medicines Agency (EMA), United Kingdom

Faster Regulatory Approvals and Better Access for Patients – Progress towards Squaring the Circle
Simon Bennett, MSc
Director, EU Regulatory Policy
Biogen, United Kingdom