2026-02-03 2026-02-03 , online online, 1,990 € zzgl. MwSt. All about ATMP

The online training with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA) for advanced therapy medicinal products. Qualifiy now!

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)


Who should attend
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.
Ziel der Veranstaltung
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).
Teilnehmerkreis

After participating in this online seminar you will be equipped with a tool box as well as practical tipps and hints to master

  • your clinical development including GMP-relevant aspects
  • the marketing autorisation process - requirements for the central approval procedure and hospital exemption
  • the market access strategy.

Online training Pharma - All about ATMP

All about ATMP

Development - Quality - CMC - Authorisation - Market Access

Benefits
  • Authority + industry position
  • A wide range of topics on two days
  • Examples for implementation in practice
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 26032470

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Alles auf einen Blick

Termin

23 - 24/03/2026

23 - 24/03/2026

Zeitraum

Day 1: 09:00 am - 05:00 pm CET - Online training
Day 2: 09:00 am - 05:30 pm CET - Online training
You may dial in 30 minutes before the session starts

Day 1: 09:00 am - 05:00 pm CET - Online training
Day 2: 09:00 am - 05:30 pm CET - Online training
You may dial in 30 minutes before the session starts
Veranstaltungsort

online

online

Gebühr
Ihre Kontaktperson

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

+49 6221 500-652
b.wessels@forum-institut.de

Details

The online training with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA) for advanced therapy medicinal products. Qualifiy now!

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)


Who should attend
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.

Ziel der Veranstaltung

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).

Teilnehmerkreis

After participating in this online seminar you will be equipped with a tool box as well as practical tipps and hints to master

  • your clinical development including GMP-relevant aspects
  • the marketing autorisation process - requirements for the central approval procedure and hospital exemption
  • the market access strategy.