- Online training -
Webcode 23112451
Dr. Steffen Groß
Paul-Ehrlich-Institut (PEI), Langen
Dr. Michael Jandke
Miltenyi Biomedicine, Bergisch Gladbach
Direktor Regulatory Affairs EU
Dr. René Thürmer
- requested - Expert for Pharmaceutical Quality, Bonn, Germany
16/11/2023
16/11/2023
9:00 am - 5:30 pm - Online trainingY...
9:00 am - 5:30 pm - Online training
You may dial in 30 min in advance
online
online
Event - 1,150 € 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 - 1,150 € 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
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.
Benefit especially from shared know-how, experiences and tipps & tricks from both - authorities and industries perspective!
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
Get to know our Learning Space and gain confidence: You can attend one of our one of our PreMeetings free of charge, registration is not required. Dates and access data for our PreMeetings can be found in your customer account. A PreMeeting offers the opportunity to get to know our Learning Space better. It is a non-binding offer for all customers and is not a prerequisite for your participation. If no date of a PreMeeting does not suit you, but you would like a technical check in advance, please contact us. please do not hesitate to contact us.
Overall score of all evaluations in 2022
Five stars on Trustpilot = Excellent
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chan...
To make the most of ICH Q12 opportunities you as a lifecycle manager have to be aware of the relation between ICH guidel...
Four live webcasts à 2 hours every week in November 2023: CMC requirements in Levant (Morocco, Tunisia, Jordan, Lebanon,...
Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more abo...
This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.
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
