Conference Agenda

Pre-Conference Workshop

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
  • USA
  • 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.

Led By:

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

Real-World Data

  • Regulatory considerations
  • How they fit into the Development and
    commercialization plan
  • 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

Interested in leading a workshop or master class?

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