- Online training -
Webcode 24032471
Dr. Thorsten Meyer
Granzer Regulatory Consulting & Services GmbH, Munich, GERMANY
Principal Consultant
Dr. Ralf Sanzenbacher
Paul-Ehrlich-Institut (PEI), Langen, GERMANY
Jessica Cordes
Senior Consultant and Trainer
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
Miltenyi Biomedicine, Bergisch Gladbach, GERMANY
EU Head RA
Dr. Willi Schnorpfeil
WS Value & Dossier GmbH, Eschborn, GERMANY
Owner
More information please click here.
Dr. Sabrina Schmeckebier
Paul-Ehrlich-Institut, Langen, GERMANY
Keine ausführliche englische Beschreibung vorhanden
More information please click here.
14-15/03/2024
14-15/03/2024
Both days: 09:00 am - 5:30 pm - semi...
Both days: 09:00 am - 5:30 pm - seminar
You may dial in 30 minutes before the training starts
online
online
Event - 1,890 € plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
e-Learning: CTD Module 3
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
Event - 1,890 € plus tax
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
340,00 €
e-Learning: CTD Module 3
, online
Ihr Buchungsvorteil: Sie buchen das Seminar regulär und das e-Learning dazu. Der Preis des e-Learnings reduziert sich um € 50,00 (€ 340,00 statt € 390,00 zzgl. MwSt.)
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 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).
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
09:30
Dr Ralf Sanzenbacher
10:45
Dr Ralf Sanzenbacher
11:30 Coffee break
11:45
Dr Thorsten Meyer
12:30 Lunch break
13:30 Continuation: Requirements for the non-clinical development of ATMPs
15:00
Dr Ralf Sanzenbacher
15:15 Coffee break
16:30
Dr Ralf Sanzenbacher, Dr Thorsten Meyer
17:30 End of seminar day 1
09:00
Jessica Cordes
11:00 Coffee break
11:15
Dr Sabrina Schmeckebier
12:00 Lunch break
13:00
Dr Sabrina Schmeckebier
14:00
Dr Michael Jandke
15:45 Coffee break
16:00
Dr Willi Schnorpfeil
17:00 Concluding discussion
17:30 End of training course
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
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.
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.
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!
