2025-04-11 2025-04-11 , online online, 1,290 € zzgl. MwSt. Dr. Steffen Groß https://www.forum-institut.de/seminar/25112453-cmc-for-biologicals/referenten/25/25_11/25112453-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

  • The references to regulatory requirements/guidelines, the overview of required studies that are reviewed by the authorities prior to market authorisation" were extremely helpful for participants last year.
  • "A very good overview of the relevant topics" is how one person would characterise the event to their colleagues.

Online-Seminar Pharma - CMC for Biologicals

CMC for Biologicals

- Online training -

Benefits
  • In-depth know-how from different prespectives
  • Considerations for the implementation of QbD
  • Submit your questions prior to the course
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25112453

Jetzt buchen

JETZT Buchen
Referenten

Dr. Steffen Groß

Paul-Ehrlich-Institut (PEI), Langen

Dr Gross has extensive experience in molecular and cell biology. In his current position, he is involved in the assessment of the quality and preclinical issues for marketing authorisation applications, scientific advices and clinical trial applications.

Dr. Michael Jandke

Independent consultant

Since August 2024, Dr Jandke has been serving as an independent consultant. Prior to that, he worked at Miltenyi from 2019, where he held responsibility for Regulatory Affairs across the European Union. Before his tenure at Miltenyi Biomedicine, Michael held various leadership roles within innovative healthcare companies, focusing on areas such as somatic cell-based medicinal products (sCBMP), tissue-engineered products (TEP), and gene therapeutics, as well as in the generic pharmaceutical sector. Dr Jandke studied Pharmacy at Humboldt University in Berlin and earned a Doctorate in Molecular Medicine from the same institution.

Dr. René Thürmer

- requested - Expert for Pharmaceutical Quality, Bonn, GERMANY

Alles auf einen Blick

Termin

06/11/2025

06/11/2025

Zeitraum

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

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

online

online

Downloads
Gebühr

Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Veranstaltung - 1,290 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.

Inhouse-Angebote
Inhouse-Angebot anfordern
Inhouse-Angebot anfordern

Jetzt buchen

Your contact

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

  • The references to regulatory requirements/guidelines, the overview of required studies that are reviewed by the authorities prior to market authorisation" were extremely helpful for participants last year.
  • "A very good overview of the relevant topics" is how one person would characterise the event to their colleagues.

Detailed programme

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

Benefits of a FORUM Institut training course

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.

  • Live and interactive learning on our Learning Space training platform
  • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
  • Easy surveys with Slido
  • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
  • A central repository for documents and media
  • Other services and apps such as Padlet and Mentimeter available directly on the platform
  • The perfect marriage of teaching methods and technology
  • High level of interactivity with plenty of opportunity for questions
  • Continuous support throughout the event to ensure the most effective learning
  • Free technical pre-meeting to start off your training on the right foot

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

This distinguishes our events

of 5 stars of all ratings from 2024

of 5 stars on Trustpilot = good

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We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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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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