- Understanding the challenges in planning and implementing a global EAP
- Country specific framework and requirements to access investigational drugs
- Scientific elements and regulatory tools available to address the challenges and explore the flexibility within the current regulatory systems
- Significant degree of administrative effort required to initiate the programme for a timely access
- How far are we from establishing a harmonised guidelines across Americas?
Moderator:
Monica L Weldon, President/CEO/Founde, SYNGAP1 Foundation
Panelist:
Rachel Harrison, Associate Director, Early Access Program, Apellis Pharmaceuticals
Eugean Jiwanmall, Sr Research Analyst, Med. Policy & Tech Evaluation, Independence Blue Cross
Amber Bifolck Fisher, Clinical Research Manager, Kura Oncology, Inc.
Wyndi Phillips, Vice President, Project Management, WEP Clinical

Annmarie Galli, Head, Global Medical Affairs Research and Compassionate Use / Managed Access Programs
Oncology, GSK