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HTA AND OFF-LABEL USE
Session Chair(s)
Lidia Retkowska-Mika, LLM
Director Legal DPT
Office For Registration of Med. Products, Medical Devices and Biocides, Poland
Legal Constraints on Off-Label use and HTA and Reimbursement Decisions
Learning Objective : 1. Understand the legal constraints on off-label use. 2. Explore the limitations set by the marketing authorisation regime for off-label based HTA and reimbursement policies
Speaker(s)
Legal Constraints on Off-Label use and HTA and Reimbursement Decisions
Peter W.L. Bogaert, MA
Covington & Burling LLP, Belgium
Partner
Off-Label Use of Medicinal Products- a solution for the healthcare system or escape from cost for Marketing Authorisation Holder?
Anna Maria Cieslik, DrMed, MPharm
Office For Registration of Medicinal Products, Poland
The “Incurable” Patients’ Perspective
David Head, MBA
RP Fighting Blindness, United Kingdom
Chief Executive
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