GLG welcomes Professor Jean-Jacques Zambrowski to discuss:
- The criteria and application process required to achieve orphan designation from the European Medicines Agency (EMA)
- The role of the Committee for Orphan Medicinal Products (COMP) and best practices for engaging the COMP
- How country-specific Health Technology Assessment (HTA) organisations review and evaluate orphan medical products for relative effectiveness, using France as a case study
- Commonalities and differences between country HTAs for orphan medical products, role of the European Network for Health Technology Assessment in managing this
- Recent and potential changes to orphan drug assessments, and significance within the wider European market
- Implications for how pharmaceutical companies approach development and commercialisation for orphan indications
Jean-Jacques Zambrowski, MD, PhD
Professor of Health Policies, Health Law and Health-Economics at University of Paris-Saclay
Prof. Zambrowski is frequently appointed as an Expert and a Consultant for several public and institutional organisations (WHO, European Commission, French Ministry of Health, French Federation of Hospitals) and for private companies in the pharmaceutical industry, including medical devices. Additionally, he is a Senior Consultant for Decision Sante, a leading group in healthcare-related services in edition, consulting and education. Prof. Zambrowski is often invited as an outside expert advisor by both the evaluation authority [Transparency Committee (CT)] and Economic Evaluation Committee (CEESP), within the French High Authority for Health (HAS), as well as by the pricing authority (CEPS).
Please note, Prof. Zambrowski will not discuss Société Française De Santé Digitale, and any of his advisory, employment, contractual roles. He may have limitations on what he is permitted to discuss and will decline to answer questions which are related to confidential matters.
Additionally, this Teleconference will be recorded. Attendees who ask questions or make comments will not be identified (either by name or affiliation.)