All Timing Below in EST - for CET See Full Event Guide

8:30 am

Morning Registration and Virtual Networking

8:45 am Chair’s Opening Remarks

  • Paul Aliu Head of Global Governance, Chief Medical Office (CMO), Novartis

Initial Considerations: Pharmacovigilance, Regulatory & Operational

9:00 am Changing Hats: Adapting to an Expanded Access Program When Your Mind is in Clinical Trial Management

  • Donna Cowan Expanded Access and Clinical Program Manager, Stealth BioTherapeutics

9:25 am Operational Planning for a Successful Global EAP

  • Paula Singer Global Medical Affairs, Senior Manager Early Access Programs, Alnylam Pharmaceuticals

9:50 am Expanded Access – When Marketing Authorisation is Withdrawn

  • Kieron Lewis Director of Strategic Consulting, Clinigen Group

10:15 am Morning Q&A – Ask the Speakers Your Questions

  • Donna Cowan Expanded Access and Clinical Program Manager, Stealth BioTherapeutics
  • Kieron Lewis Director of Strategic Consulting, Clinigen Group
  • Paula Singer Global Medical Affairs, Senior Manager Early Access Programs, Alnylam Pharmaceuticals

10:30 am Solid Foundations – Operationalizing the Set Up for an Expanded Access Program

  • Dawn Sullivan Sr. Program Manager, Department Lead, UltraPrograms, Ultragenyx Pharmaceutical
  • Philipp Schlatter Community of Practice Leader Post Trial Access & Drug Supply, Roche
  • Ramona Reichenbach Head of Managed Access Center of Excellence (MACoE), Novartis
  • Erin Lambert Expanded Access Lead, Argenx
  • Pat Furlong Founding President & CEO, Parent Project Muscular Dystrophy (PPMD)

11:10 am

Virtual Speed Networking

11:40 am Morning Break

11:50 am Overcoming Regulatory Barriers to Running Early Access Programs in Europe

  • Geoff Fatzinger Managing Director, CCPS UK, Global Vice President, Regulatory Affairs, Quality and Strategic Services, Caligor Coghlan Pharma Services

12:15 pm Navigating the Diverse Regulatory Differences Between EU Countries

12:40 pm Regulations: Exploring the Differences Between Trial Protocol and EAP Treatment Procedures

  • Richard Klein Director, Expanded Access Programs & Policy, GE2P2 Global Foundation

1:05 pm Midday Q&A – Ask the Speakers Your Questions

  • Georges van Baelen Founder & CEO, Arctiryon
  • Richard Klein Director, Expanded Access Programs & Policy, GE2P2 Global Foundation
  • Geoff Fatzinger Managing Director, CCPS UK, Global Vice President, Regulatory Affairs, Quality and Strategic Services, Caligor Coghlan Pharma Services

1:20 pm Lunch Break & Vitual Networking

Set Up, Supply & Strategy

2:20 pm Going Remote With Pre-Approval Access – Lessons Learnt From the COVID-19 Pandemic

3:00 pm Operationalizing EAPs: Lessons Learnt and Best Practice Sharing

3:20 pm Overcoming Logistical Challenges with Supply Chain Maintenance

3:45 pm Afternoon Q&A – Ask the Speakers Your Questions

3:55 pm Chair’s Closing Remarks

  • Paul Aliu Head of Global Governance, Chief Medical Office (CMO), Novartis

4:05 pm Day 1 Debrief- your chance to join the conversation

4:35 pm

End of Conference Day One