2021-12-24 2022-03-25 , Online Online, 1.690,- € zzgl. MwSt. Dr. Thorsten Meyer https://www.forum-institut.de/seminar/22032470-all-about-atmp/referenten/22/22_03/22032470-online-course-pharma-all-about-atmp_meyer-thorsten.jpg All about ATMP

The online seminar on the topics of 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)
Aims and objectives
In 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).
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.

Online course pharma - All about ATMP

All about ATMP

- Online training -

Benefits
  • Excellent speakers
  • The most important in two days
  • Current developments in a compact format
  • Online format: flexible, modern, interactive
  • We follow the IMI quality criteria

Webcode 22032470

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Referenten


Alles auf einen Blick

Termin

24. - 25.03.2022

24. - 25.03.2022

Zeitraum

Day 1: 09:00 am -5:30 pmDay 2: 09:00...

Day 1: 09:00 am -5:30 pm
Day 2: 09:00 am -3:30 pm
Veranstaltungsort

Online

Online

Downloads
Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Konferenzmanagerin Healthcare

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

Details

The online seminar on the topics of 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)
Aims and objectives

In 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).

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.

Detailed programme

Day 1: 09:00 am -5:30 pm
Day 2: 09:00 am -3:30 pm

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 on 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


13:30 Continuation: Requirements on the non-clinical development of ATMPs


15:00 Coffee break


15:15

Dr Ralf Sanzenbacher

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

16:00

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

17:15 Q&As Day 1


17:30 End of Day 1


09:00

Dr Egbert Flory

Classification of ATMPs
  • Reflection paper on classificationof 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
  • Critical quality data from pharma-ceutical 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 in Germany
  • AMNOG process
  • ATMPs and Orphan drugs
  • Application accompanying data collection
  • Results and experiences
  • Upcoming EU HTA

15:15 Concluding discussion


15:30 End of training course


More information

Optional online test/learning success check

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.

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.

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

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. 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!

Dr. Sabine Sembries

Bayer AG