Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI), Langen
Dr. Michael Jandke
Miltenyi Biomedicine, Bergisch Gladbach
VP Global Regulatory Affairs
Dr. René Thürmer
Experte für Arzneimittelzulassung, Bonn
Experte für pharmazeutische Biotechnologie, Schwerpunkt Inspektionen
22.11.2022
22.11.2022
9:00 am - 5:30 pm Online trainingYou...
9:00 am - 5:30 pm Online training
You may dial in 30 min in advance
online
online
Event - 1.090,- € plus tax
The fee includes course documentation for download and a certificate.
Event - 1.090,- € plus tax
The fee includes course documentation for download and a certificate.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Get your know-how on creating and maintaining quality data for biotech products in our online training via Zoom.
The requirements for Module 3 of the CTD differ fundamentally for biotech products from those for non-biologics.
In this online training, you will gain knowledge with regard to CMC management specifically for biologicals.
After participating in the seminar, you will be familiar with the ICH guidelines, which form the regulatory framework. You will know which data are required for Module 3 and which significant differences exist to non-biologics. You will know the specifics of the documentation for antibodies, immunoglobulins and recombinant proteins and have been provided with practical solutions. Our experts will discuss the comparability requirements in the event of a change by means of a case study.
Finally, you will work out in the workshop which data is mapped in the dossier and how, and learn how to skilfully avoid common mistakes.
This online training is aimed at specialists and managers in the biopharmaceutical industry who are responsible for creating and maintaining the quality module in the CTD or who make a significant contribution to this.
Especially addressed are the departments of regulatory affairs, medical science, quality assurance and quality control.
09:00
Dr Michael Jandke
10:30 Coffee break
10:45
Dr Steffen Groß
12:15
Dr. Steffen Groß
13:00 Lunch break
14:00
Dr René Thürmer
15:15 Coffee break
15:30
Dr Michael Jandke
17:15 Summary and outstanding questions
17:30 End of online training
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.
Overall score of all evaluations in 2021
Five stars on Trustpilot = Excellent
The course provides practical, hands-on experience in eCTD specifications, eSubmission requirements and data integrity f...
Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...
Our global and local experts will update you every two months with the latest regulatory and legislative developments. T...
Our biotech experts will provide you with the latest information on issues related to development, quality and regulator...
Our biotech experts will provide you with the latest information on issues related to development, quality and regulator...
Teilnehmerstimmen aus November 2015
Qualifizierte Referenten, praxisorientiert, Fragen werden beantwortet
Ruth Bemelsmann
acora Pharma GmbH
Guter Überblick, Eingehen auf persönliche Fragen - auch spontan während des Vortrags; ich weiß, wo ich nachschauen muss und was ich vermeiden sollte.
Dr. Thomas Stibora
Merz Pharma GmbH & Co. KGaA
Sehr interessant & aktuell, empfehlenswert, sehr hilfreich, um Kenntnisse wieder aufzufrischen und neues zu lernen, aktuelle Informationen aus den Behörden, sehr gut betreutes Seminar, sehr fachspezifische und auch tiefergehende Themen behandelt, sehr anschaulich gestaltet
Teilnehmerstimmen aus Oktober 2016
Kompakter Überblick, gut dargestellt; präzise Beantwortung der Fragen, Dozenten alle sehr freundlich & bemüht alle Fragen zu beantworten
Veranstaltung aus meiner Sicht sehr empfehlenswert!; hervorragende fachliche Kompetenz der Referenten; sehr umfangreiche Dokumentation
Gute Übersicht, viele Informationen, freundliche Atmosphäre, sehr informativ