2023-02-02 2023-02-02 , online online, 1,690 € zzgl. MwSt. Dr. Thorsten Meyer https://www.forum-institut.de/seminar/23032470-all-about-atmp/referenten/23/23_03/23032470-online-course-pharma-all-about-atmp_meyer-thorsten.jpg All about ATMP

The online seminar with details on development, quality, CMC, approval and market access for advanced therapy medicinal products. Secure your place in our virtual seminar via Zoom.

Topics
  • From blood, tissues & cells to ATMP
  • GMP and Module 3 requirements for ATMPs
  • Requirements for non-clinical development
  • Classification of ATMPs
  • Hospital exemption vs. central approval process
  • Early benefit evaluation (focus 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.
Aims and objectives
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 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 (focus on Germany).
Your benefit

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 course pharma - All about ATMP

All about ATMP

- Online training -

Benefits
  • Meet the experts
  • Authoritie's + industrie's point of view
  • Provide your individual cases and discuss practical examples
  • We follow the IMI quality criteria

Webcode 23032470

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

22-23/03/2023

22-23/03/2023

Zeitraum

Day I: 09:00 am - 5:00 pm - seminarD...

Day I: 09:00 am - 5:00 pm - seminar
Day II: 09:00 am - 3:30 pm - seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Gebühr
Ihre Kontaktperson

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

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

Details

The online seminar with details on development, quality, CMC, approval and market access for advanced therapy medicinal products. Secure your place in our virtual seminar via Zoom.

Topics
  • From blood, tissues & cells to ATMP
  • GMP and Module 3 requirements for ATMPs
  • Requirements for non-clinical development
  • Classification of ATMPs
  • Hospital exemption vs. central approval process
  • Early benefit evaluation (focus 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.
Aims and objectives

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 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 (focus on Germany).

Your benefit

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.

Detailed programme

Day I: 09:00 am - 5:00 pm - seminar
Day II: 09:00 am - 3:30 pm - seminar
You may dial in 30 minutes before the training starts

09:00 Opening and introduction


09:15

Dr Ralf Sanzenbacher

From blood, tissues & cells to ATMP
  • Overview on product classes, new developments, procedures, responsible authorities, and contact points

10:30 Coffee break


10:45

Dr Ralf Sanzenbacher

Product development and quality aspects
  • How to define the quality of an ATMP
  • GMP for ATMP

11:30

Dr Thorsten Meyer

Requirements for the non-clinical developement of ATMPs
  • Animal models for efficacy and toxicity testings
  • Determination of a secure starting dose and therapeutic dose

12:30 Lunch break


13:15 Continuation: Requirements for the non-clinical development of ATMPs


14:45 Coffee break


15:00

Dr Ralf Sanzenbacher

German national aspects for development and authorisation
  • National procedures
  • Update on regulatory setting for clinical trials and on hospital exemption

15:30

Dr Ralf Sanzenbacher and Dr Thorsten Meyer

Interaction between companies and authorities
  • Do's and don't's from stakeholder and authority point of view

16:45 Q&As


17:00 End of seminar day 1


09:00

Dr Egbert Flory

Classification of ATMPs
  • Reflection paper on classification of ATMPs
  • Scientific recommendations
  • Experiences of the CAT; product examples

09:45

Dr Egbert Flory

Centralised authorisation procedure
  • Role of the CAT
  • The centralised authorization procedure of the EMA
  • The risk based approach for ATMPs
  • Special authorisation procedures

10:45 Coffee break


11:00

Dr Michael Jandke

CMC requirements: Essential module 3 data for ATMPs
  • Quality data from pharmaceutical development, characterisation, production, control strategy

12:00 Lunch break


13:00 Continuation: CMC requirements - essential module 3 data for ATMPs


14:00 Coffee break


14:15

Dr Willi Schnorpfeil

Early benefit evaluation for ATMPs (focus Germany)
  • AMNOG process
  • ATMPs and Orphan drugs
  • Application accompanying data collection
  • Results and experiences
  • Upcoming EU HTA
  • National/european examples

15:15 Summary and outstanding questions


15:30 End of training course


More information

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

  • You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
  • Use a headset, loudspeakers or the telephone for audio.
  • Listen to the speaker and follow the presentation.
  • Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

Optional online test/learning success control

After taking part in the seminar, you can take our online multiple-choice test.
This can be completed online up to 14 days after the event in order to document the acquired knowledge with a special certificate.
Taking the online test is optional. You will receive a certificate of participation regardless.

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Overall score of all evaluations in 2022

Five stars on Trustpilot = Excellent

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Quality guaranteed!

Your feedback produced as result of 1.8 in 2022. Thank you!

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More on our quality criteria

Testimonials

Teilnehmerstimmen aus Mai 2016
sehr informativ, gibt einen Überblick über ATMPS/Klassifizierung zu bekommen


Gut aufgearbeitet, keine Redundanz, sehr kompetente Referenten


Die Veranstaltung bietet einen guten Überblick.

Teilnehmerstimme aus Mai 2020
Ein sehr empfehlenswertes, hervorragendes Seminar, das einen exzellenten Gesamtüberblick zum Thema ATMPs gibt!