2024-02-26 2024-02-26 , online online, 1,890 € zzgl. MwSt. Dr. Thorsten Meyer https://forum-institut.de/seminar/24032471-all-about-atmp/referenten/24/24_03/24032471-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 clinical and 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 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 (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-Weiterbildung -

Benefits
  • Authority's + industry's position
  • NEW: Detailed talk on clinical aspects during ATMP development
  • Examples for implementation in practice
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 24032471

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Referenten


Alles auf einen Blick

Termin

14-15/03/2024

14-15/03/2024

Zeitraum

Both days: 09:00 am - 5:30 pm - seminar
You may dial in 30 minutes before the training starts

Both days: 09:00 am - 5:30 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 clinical and 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 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 (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

Both days: 09:00 am - 5:30 pm - seminar
You may dial in 30 minutes before the training starts

09:00 Opening and introduction


09:30

Dr Ralf Sanzenbacher

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

10:45

Dr Ralf Sanzenbacher

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

11:30 Coffee break


11:45

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


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


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

15:15 Coffee break


16:30

Dr Ralf Sanzenbacher, Dr Thorsten Meyer

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

17:30 End of seminar day 1


09:00

Jessica Cordes

Clinical aspects to be considered during ATMP development
  • Ethical and regulatory aspects
  • Clinical trial planning
  • Specifics for clinical trial implementation

11:00 Coffee break


11:15

Dr Sabrina Schmeckebier

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

12:00 Lunch break


13:00

Dr Sabrina Schmeckebier

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

14:00

Dr Michael Jandke

Essential module 3 data for ATMPs
  • Critical quality data from pharmacutical development, characterisation, pro-duction, control strategy

15:45 Coffee break


16:00

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

17:00 Concluding discussion


17:30 End of training course


More information

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

Benefits of a FORUM Institut training course

FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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.

This distinguishes our events

Overall score of all evaluations in 2023

Five stars on Trustpilot = Excellent

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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!