- Online training -
Webcode 23032470
Dr. Thorsten Meyer
Granzer Regulatory Consulting & Services GmbH, Munich
Principal Consultant
Dr. Ralf Sanzenbacher
Paul-Ehrlich-Institut (PEI), Langen
Dr. Egbert Flory
Paul-Ehrlich-Institut (PEI), Langen
Dr. Michael Jandke
Miltenyi Biomedicine, Bergisch Gladbach
EU Head Regulatory Affairs
Dr. Willi Schnorpfeil
WS Value & Dossier GmbH, Eschborn
Owner
More information please click here.
22-23/03/2023
22-23/03/2023
Day I: 09:00 am - 5:30 pm - seminarD...
Day I: 09:00 am - 5:30 pm - seminar
Day II: 09:00 am - 3:30 pm - seminar
You may dial in 30 minutes before the training starts
online
online
Event - 1,690 € plus tax
The fee includes course documentation for download and a certificate.
SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
Event - 1,690 € plus tax
The fee includes course documentation for download and a certificate.
SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
Dr. Birgit Wessels
Konferenzmanagerin Healthcare
+49 6221 500-652
b.wessels@forum-institut.de
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.
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).
After participating in this online seminar you will be equipped with a tool box as well as practical tipps and hints to master
09:00 Opening and introduction
09:15
Dr Ralf Sanzenbacher
10:30 Coffee break
10:45
Dr Ralf Sanzenbacher
11:30
Dr Thorsten Meyer
12:30 Lunch break
13:15 Continuation: Requirements for the non-clinical development of ATMPs
14:45 Coffee break
15:00
Dr Ralf Sanzenbacher
15:30
Dr Ralf Sanzenbacher and Dr Thorsten Meyer
16:45 Q&As
17:00 End of seminar day 1
09:00
Dr Egbert Flory
09:45
Dr Egbert Flory
10:45 Coffee break
11:00
Dr Michael Jandke
12:00 Lunch break
13:00 Continuation: CMC requirements - essential module 3 data for ATMPs
14:00 Coffee break
14:15
Dr Willi Schnorpfeil
15:15 Summary and outstanding questions
15:30 End of training course
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.
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
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
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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!
