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Defining Unmet Medicinal Need and Implications for Regulatory Strategy
Session Chair(s)
Kristina Larsson, MS
Head of Orphan Medicines, Division for Human Medicines Evidence Generation
European Medicines Agency, Netherlands
Thomas Metcalfe, MBA
Personalised Healthcare Ecosystems
F. Hoffmann-La Roche, Switzerland
Unmet medical need (UMN) is a provision in the pharmaceutical legislation for human medicines, but experience has shown that it can be difficult to apply (Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions - PubMed (nih.gov)). In this session we will present the current perspectives of UMN, discuss any new proposals for a definition that have emerged from the proposal for the revision of the pharmaceutical legislation, and debate options and challenges for their application.
Learning Objective : Participants will get an overview on the current use of “unmet medical need” for decision-making but also gain an understanding of what the future holds in light of the revision of the European pharmaceutical legislation. A debate on definitions between patients, clinicians, developers, HTAs and regulators will elucidate the challenges.
Speaker(s)
Isabelle Huys, PharmD, PhD, MPharm
KU Leuven, Belgium
Professor
Industry Perspective
Tina Taube, MS
EFPIA, Belgium
Director Market Access & Orphan Drug Policy Lead
Patient Perspective
Claudia Louati, MA, MSc
European Patients' Forum, Belgium
Head of Policy
Regulator's perpective
Maria Boulos
European Medicines Agency, Netherlands
Scientific Administrator
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