All about ATMP - Development - Quality - CMC - Authorisation - Market Access

Die Themen

- From blood, tissues & cells to ATMP - GMP and Module 3 requirements for ATMPs - Requirements for clinical and non-clinical development - Classification of ATMPs - Hospital exemption vs. central approval process - Early benefit evaluation, including an update on the EU HTA (focus in general on Germany)

Ziele

During this seminar, you will learn to master the challenges from development to approval to market access of an ATMP. After the seminar, you will know which GMP regulations must be included for ATMPs as part of product development. You will be familiar with the requirements for clinical and non-clinical development too. In addition, you have been brought up to date with regard to the regulatory requirements for marketing authorization (national, EU). You know the individual steps in the central approval procedure and the requirements for hospital exemption. Last but not least, you have acquired the know-how to set the right course for benefit assessment and market access (including an update on the EU HTA, first experiences with ATMPs).

Wer sollte teilnehmen?

This seminar is aimed at specialists and managers in the pharmaceutical and biotechnology industry who work with gene-, cell- and tissue-based products or plan to do so in the future.

- The aim is to impart ‘basic knowledge’ for beginners in the field.