- Online training -
Webcode 24112453
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI), Langen
Steffen Gross has extensive experience in molecular and cell biology. Mr. Gross joined the Paul-Ehrlich Institute in 2005 and became Head of the Section monoclonal and polyclonal antibodies in 2012. Due to re-structure of the section he became Head of Section Quality and Non-clinical Evaluation of Antibody therapeutics" in 2022. He is involved in the assessment of the quality and preclinical issues for marketing authorization applications, scientific advices and clinical trial applications. Until 2012 Mr. Gross was laboratory head of the section monoclonal and polyclonal antibodies and involved in testing of immunoglobulins, immunsera and monoclonal antibodies. Before joining the Paul-Ehrlich Institute he worked in the Netherland for three years as a postdoc. During this time he had been working several months at the National Institute of Health in Bethesda. After his return to Germany in 2001 he became a research group leader at the University of Frankfurt.
Dr. Michael Jandke
Miltenyi Biomedicine, Bergisch Gladbach, GERMANY
EU Head RA
Dr. René Thürmer
Expert for Pharmaceutical Quality, Bonn, Germany
04/11/2024
04/11/2024
9:00 am - 5:30 pm - Online training
You may dial in 30 min in advance
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
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
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 €
Veranstaltung - 1,190 € zzgl. MwSt.
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
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
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.
The requirements for Module 3 of the CTD differ fundamentally for biotech products from those for non-biologics.
During 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.
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 Q&As and outstanding questions
17:30 End of online training
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.
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
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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
