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Regulatory Access Pathways to Facilitate Early Access and HTA Synergies

Track:
Can Regulators and HTA Bodies Create Synergies for Patient Access?

Day & Time:
April 17, 2:00PM - 3:15PM (Central Europe Standard Time)

Session Number:
S0102

Type:
Session

Title:
Regulatory Access Pathways to Facilitate Early Access and HTA Synergies

Chair(s):
Indranil Bagchi, PhD, MS
Vice President and Franchise Head, Global Value and Access
Novartis Oncology, United States

Jordi Llinares Garcia
Head of Scientific and Regulatory Management
European Medicines Agency, European Union, United Kingdom

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

Panel Discussion
Simon Bennett, MSc
Director, EU Regulatory Policy
Biogen Limited, United Kingdom