Monday - 28th November 2022
Free of Charge Workshop - Limited Spaces Available - Register Now!
Complete The Form Below To Confirm Registration
Afternoon Workshop: Early Access Programs
This interactive presentation will provide you with an opportunity to learn more about how EAP’s provide pre -launch access for drugs in advance of their Marketing Authorization (MA) for patients with life-threatening conditions and no approved treatment options. Best practices in EAP planning, Set-Up and management, and provide information on current regulatory changes
WHO IS IT FOR?
This workshop will be extremely beneficial to those individuals considering an EAP as part of their drug development strategy. Project Managers and Executives in Pharma/Biotech/Advocacy interested in knowing how to set-up an Early Access Program.
13.30 – 3:00
- Motivations for Companies to Allow Expanded Access
- Nomenclature for Early Access
- Global Regulatory Pathways
– US – Expanded Access (deep dive)
– Canada – Special Access
– Europe – Key Markets
– Asia/Latin America/MENA
- How companies can plan for Early Access Operational Considerations for Implementation of an Early Access Program Case Studies
3:00 – 3:30 – Networking Break
3:30 – 5:00
- Ways to mitigate risk in an Early Access Program
- Implications of charging and who pays
- Data capture during Early Access
Compliant awareness building for Early Access
- Early Access as Part of a Global Market Access Strategy
- Challenges of Early Access for Cell and Gene Therapies
Complete The Form Below To Confirm Registration – Free Access – Subject to Availability.