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Expanded Access and Compassionate Use
Session Chair(s)
Ramana Sonty, MD, PHD
Director, Global Medical Organization, Johnson & Johnson, United States
Early access to medicines is increasingly sought by patients, physicians and legislators. Regulators and industry must work together to optimize patient access ethically and in a medically appropriate way while remaining focused on registration efforts. How to find the right balance? What are some case examples?
Learning Objective : Discuss case studies of patient need and access approaches prior to regulatory approval.
Speaker(s)
Kevin Bugin, MS, RAC
Head of Global Regulatory Policy and Intelligence, Amgen, United States
CDER Experience: Expanded Access in Drug Development and Review
Elena Gerasimov, MA, MPH
Director, Compassionate Use Navigator Program, Kids V Cancer, United States
Making Compassion Work: Challenges and Next Steps
Ramana Sonty, MD, PHD
Director, Global Medical Organization, Johnson & Johnson, United States
Independent Evaluation of Compassionate Use Requests to Benefit Patients: The NYU J&J CompAC
Grant Strachan, LLM
Senior Associate, Regulatory , Brodies LLP Solicitors Capital House, United Kingdom
Navigating the Regulatory Pathways of Early Access to Medicines in the EU
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