Wednesday 16th February 2022
Afternoon Workshop: Early/Expanded Access Programs
About the Workshop
- This interactive workshop will provide you with an ideal learning opportunity on Early/Expanded Access
Programs and how they fit into Development and Commercialisation programs.
- It will give you a global overview of Access Programs and provide you with a practical tool kit for the decision process on whether an EAP is suitable for your therapy and if so how to implement one.
- The workshop will cover the modifications needed for differing therapies such as Cell and Gene Therapies and the differing types of programs form individual to cohort, compassionate, and charged.
- Led by industry experts – this will be a practical session giving real-life examples of best practices.
Who is it for?
- Executives in Pharma / Biotech looking at rapidly accelerating their drug development and commercialization
- Medical Affairs and Market Access professionals who want to understand the role of EAP
EAP Project Managers, charged with initiation or management.
1:30 – 3:00 PM
Global Regulatory review
- A European overview – Spotlight on DE, FR, RO, Nordics, IT
- Middle Eastern programs – Spotlight on UAE & Saudi
- RoW overview – Spotlight on Australia, Brazil, Hong Kong
Case study / Exercise: Implementation of a global EAP
Focus: Cell and Gene Therapies
Focus: Charged or Compassionate (Free of charge supply)
- The pros and cons of each option
- How they can be used together.
Robert Donnell, Executive Vice President, Medicines Access
The link to Market Access
- Implications for reimbursement
3:00 – 3:30 PM – Networking Break
3:30 – 5:00 PM
- Regulatory considerations
- How they fit into the Development and
- Practical guide to data set design
- Best practice guide for the collection
Project planning and risk mitigation
- Overview of project planning and design process
- A practical guide for initiation and implementation
5:00 PM – Closing remarks