Expanded Access Programmes

Seminarziel:

Are you about to decide whether an expanded access programme should be developed or are you already about to plan and execute one? Then, this seminar supports you with legal and medical know-how. After having attended the seminar you know what to bear in mind in the planning phase, have received practical tipps on how to do the medical oversight and how to determine a potential programme end.

Themen:

- Matching the programme and the company strategy
- Programme design: CUP and NPP
- Medical governance and programme integrity
- From early access to regular launch: transitional plan, pricing, supply chain
- Including exercises on pros and cons of a programme

Teilnehmerkreis:

This seminar will provide in-depth information on CUPs and NPPs to all involved in clinical affairs, medical affairs, health technology assessment (HTA) and healthcare management, particularly those who develop, plan and conduct expanded access programmes.