- Online training -
Webcode 25032470
Dr. Ralf Sanzenbacher
Paul-Ehrlich-Institut (PEI), Langen, GERMANY
Dr. Thorsten Meyer
Granzer Regulatory Consulting & Services GmbH, Munich, GERMANY
Senior Consultant
Jessica Cordes
Senior Consultant and Trainer, Munich, GERMANY
Senior Consultant and Trainer
Jessica Cordes started her Clinical Operations career in 2009, working at various companies including big pharma and several small-midsized biotech companies. She gained extensive experience on different levels from country study management, global study management and since 2018 global leadership.
During her time at Medigene and Immatics, she had structured the Clinical Operations department, built cohesive global teams and implemented GCP and ATMP compliant processes.
Since 2013 she is working for oncology clinical trials (including hemato-oncology as well as solid tumors), since 2018 also including clinical trials with Advanced Therapy Medicinal Products (ATMPs).
More information please click here.
Dr. Michael Jandke
Independent consultant
Since August 2024, Dr Jandke has been serving as an independent consultant. Prior to that, he worked at Miltenyi from 2019, where he held responsibility for Regulatory Affairs across the European Union. Before his tenure at Miltenyi Biomedicine, Michael held various leadership roles within innovative healthcare companies, focusing on areas such as somatic cell-based medicinal products (sCBMP), tissue-engineered products (TEP), and gene therapeutics, as well as in the generic pharmaceutical sector. Dr Jandke studied Pharmacy at Humboldt University in Berlin and earned a Doctorate in Molecular Medicine from the same institution.
Dr. Willi Schnorpfeil
WS Value & Dossier GmbH, Eschborn, GERMANY
Owner
More information please click here.
Dr. Sabrina Schmeckebier
Paul-Ehrlich-Institut, Langen, GERMANY
12-13/03/2025
12-13/03/2025
Day 1: 09:00 am - 5:00 pm
Day 2: 09:00 am - 5:30 pm
You may dial in 30 min before the training starts
online
online
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
The online seminar 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!
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 upcoming EU HTA; focus in general 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
Dr Thorsten Meyer
14:45 Coffee break
15:00
Dr Ralf Sanzenbacher
16:00
Dr Ralf Sanzenbacher, Dr Thorsten Meyer
16:45 Q&As
17:00 End of seminar day 1
09:00
Jessica Cordes
11:00 Coffee break
11:15
Dr Sabrina Schmeckebier
12:00 Lunch break
12:45
Dr Sabrina Schmeckebier
13:45
Dr Michael Jandke
15:30 Coffee break
15:45
Dr Willi Schnorpfeil
17:00 Concluding discussion
17:30 End of training course
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.
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.
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This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
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Hochwertiges e-Learning für Ihren fundierten und flexiblen Einstieg in das deutsche Gesundheitssystem.
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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!
