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PATIENT INVOLVEMENT IN THE DEVELOPMENT DIALOGUE WITH REGULATORY AUTHORITIES AND HTAS
Session Chair(s)
Isabelle Stoeckert, PharmD, PMP
VP. Head Regulatory Affairs Europe Middle East Africa PH
Bayer, Germany
Patient involvement in innovative drug development and access considerations is a hot topic, methodological work is rapidly evolving. The session provides insight into latest research of EMA and IMI PROTECT on patient value elicitation methodologies
Learning Objective : Aim of this session is to outline state of the art concepts how patients could be involved in medicinal product development and access to new therapies
Speaker(s)
How Can Regulatory Authorities and HTAs Build on Patient Input - the European Medicines Agency perspective
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
The Patient Perspective in Drug Development
François Houyez
European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
Patient and Public Involvement in Innovative Drug Development and Benefit/Risk Decision Making – what is state of the art after PROTECT WP5
Kimberley Hockley
Imperial College of Public Health, United Kingdom
Research Associate
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