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CHALLENGES FOR DEVELOPMENT OF RARE DISEASES
Session Chair(s)
Peter W.L. Bogaert, MA
Partner
Covington & Burling LLP, Belgium
Registries for Rare Diseases
Learning Objective : • Understand the challenges of establishing a patient registry in an ultra-orphan disease area • Understand how incremental organizational steps can be taken to create the foundation for larger and richer registries
Speaker(s)
Strategic View of a Regulator on Effective Development of Therapies for Rare Diseases
Diederick Slijkerman, PHD, LLM
Medicines Evaluation Board, Netherlands
Head of Policy, Governance & Regulatory Affairs
Registries for Rare Diseases
Badri Rengarajan, MD
Jazz Pharmaceuticals, United States
Life Sciences
Experiences from Orphan Exclusivity in the EU
Peter W.L. Bogaert, MA
Covington & Burling LLP, Belgium
Partner