2023-06-04 2023-06-04 , online online, 1,150 € zzgl. MwSt. Dr. Steffen Groß https://forum-institut.de/seminar/23112451-cmc-for-biologicals/referenten/23/23_11/23112451-online-seminar-pharma-cmc-for-biologicals_gross-steffen.jpg CMC for Biologicals

Get your know-how on creating and maintaining quality data for biotech products in our online training.

Topics

Regulatory framework: ICH guidelines
Essential data for biologics for Module 3
Challenges in Module 3: Focus on antibodies, immunoglobulins and recombinant proteins
Comparability requirements for changes
Critical data: Which data must be included in the dossier, which not?

Who should attend

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.

Aims and objectives

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.

Your benefit

Benefit especially from shared know-how, experiences and tipps & tricks from both - authorities and industries perspective!

Online-Seminar Pharma - CMC for Biologicals

CMC for Biologicals

- Online training -

Benefits

First-hand information
In-depth know-how from different prespectives
Submit your questions prior to the course
Online format without travel expenses
We are following the IMI quality criteria

Webcode 23112451

Jetzt buchen

JETZT Buchen

Referenten

Alles auf einen Blick

Termin

16/11/2023

16/11/2023

Zeitraum

9:00 am - 5:30 pm - Online trainingY...

9:00 am - 5:30 pm - Online training
You may dial in 30 min in advance

Veranstaltungsort

online

online

Downloads

Gebühr

Inhouse-Angebote

Your contact

Online-Seminar Pharma - CMC for Biologicals

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

Get your know-how on creating and maintaining quality data for biotech products in our online training.

Topics

Regulatory framework: ICH guidelines
Essential data for biologics for Module 3
Challenges in Module 3: Focus on antibodies, immunoglobulins and recombinant proteins
Comparability requirements for changes
Critical data: Which data must be included in the dossier, which not?

Who should attend

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.

Aims and objectives

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.

Your benefit

Benefit especially from shared know-how, experiences and tipps & tricks from both - authorities and industries perspective!

Detailed programme

9:00 am - 5:30 pm - Online training
You may dial in 30 min in advance

09:00

Dr Michael Jandke

Quality dossier biotech medicines: The regulatory framework

Overview of the regulatory requirements
Which institutions are involved in the approval process?
Biologics vs. non-biologics: Elementary differences
What data are required for Module 3? Among others for: Manufacture, characterisation Reference standards, stability Excipients
ATMPs: The specifics

10:30 Coffee break

10:45

Dr Steffen Groß

Challenges in Module 3: Focus on antibodies and immunoglobulins

Process validation Regulatory requirements Process evaluation and verification Continuous vs. traditional approach
Characterisation Potency Contaminants
Container Closure Systems
Stability
Implementation "Quality by Design" FMEA tools RTRT (Real Time Release Testing)

12:15

Dr Steffen Groß

Comparability requirements for changes

Requirements through the Variation Regulation
Case study

13:00 Lunch break

14:00

Dr René Thürmer

Challenges in Module 3: Focus on recombinant proteins

Analytics, validation of analytical methods
Case studies

15:15 Coffee break

15:30

Dr Michael Jandke

CMC Writing, submission strategy and resource planning

Common shortcomings in dossier evaluation: Which data must be in the dossier, which not?
CMC relevant essentials on the procedural steps of the submission
Planning resources within the company
Back-up data for Module 3 for the clock stop phase

17:15 Q&As and outstanding questions

17:30 End of online training

Our partner

Lexxion Verlagsgesellschaft mbH

More information

How does an online seminar work?

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.

You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
Use a headset, loudspeakers or the telephone for audio.
Listen to the speaker and follow the presentation.
Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

Attend the training in all comfort, from wherever you like
There are no travel and accommodation costs
Ask questions live whenever you desire

Send us your individual questions

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

This distinguishes our events

1,7

Overall score of all evaluations in 2022

4,5

Five stars on Trustpilot = Excellent

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Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

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Quality guaranteed!

Your feedback produced as result of 1.8 in 2022. Thank you!

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Testimonials

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

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