Pre-Conference Workshop Day
Tuesday, 18th October 2022
Agile Operational Planning for a Successful Pre-Approval Access Programme
10:00am - 12:00pm
A successful Pre-Approval Programme (PAA) takes foresight and planning.
There are often multiple logistical considerations when planning a PAA, especially when there are multiple countries involved and fast changing regulations.
PAAs do not have a universal way of working, and there is a lack of guidance across the industry for establishing and running these programmes.
Gain an understanding of how to be best prepared for your PAA with the aim of:
- Ensuring equity of access for patients
- Responding quickly to physician requests and patient needs
- Factoring operational challenges into the planning stage to reduce downstream delays
Natasja van Roy
Global Program Leader, Director - Managed Access
Global Program Leader, Managed Access
Distinguishing an Exit Strategy to End an Early Access Programme & Move to Commercialisation
1:00 - 3:00pm
When running an early access programme, there should be a plan to manage and implement an exit strategy on a country-by-country basis.
This strategy depends on the marketing authorisation status and local regulations in each country. This is imperative, as products in the EU are licensed through a complex procedure with product approval and launch often many months apart.
Join this workshop to learn how to:
- Establish a programme-by-programme and country-by-country exit strategy
- Identify when a drug is no longer considered investigational, and is commercially viable
- Ensure post-trial access to treatment to continue benefits for the patient