2022-11-22 2022-11-22 , online online, 1.090,- € plus tax Dr. Steffen Groß https://www.forum-institut.com/seminarDetail/73/referenten/22/22_11/22112453-online-seminar-pharma-cmc-fuer-biologicals_gross-steffen.jpg CMC for Biologicals

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

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?
Aims and objectives
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.
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.

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 22112453

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

22.11.2022

22.11.2022

Period

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

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

online

online

Downloads
Fee
Your contact person

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 via Zoom.

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?
Aims and objectives

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.

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.

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 & 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 Summary and outstanding questions


17:30 End of online training


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

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Overall score of all evaluations in 2021

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Technical requirements

Here you can find the technical requirements for our online events that must be met.

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Technical requirements
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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