Pre-Conference Workshop Day
Tuesday, 18th October 2022

WORKSHOP A

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

 

Workshop Leaders

Natasja van Roy (002)

Natasja van Roy
Global Program Leader, Director - Managed Access
Janssen

Veronique Ollivier-Guillon

Veronique Ollivier-Guillon
Global Program Leader, Managed Access
Janssen

WORKSHOP B

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

Workshop Leaders

Soetkin Vlassak

Soetkin Vlassak
Senior Medical Director Global Medical Affairs Oncology
Merck Kgaa

Kirti Joshi

Kirti Joshi
Global Operational Lead for Tepotnib Early Access
Merk Kgaa