2023-10-01 2023-10-01 , online online, 1,150 € zzgl. MwSt. Dr. Steffen Groß https://www.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 and others
  • 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

Gebühr
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 and others
  • 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 our online events work

  • Our online events take place live and interactively in the Learning Space. There you will also find all documents, the programme and the list of participants.
  • You can access the Learning Space with your account for the client portal.
  • The free PreMeeting prepares you optimally to clear any technical hurdles in advance.
  • Continuous support during the online event guarantees an optimal training experience.

PreMeeting & Technical Test

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.

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

Overall score of all evaluations in 2022

Five stars on Trustpilot = Excellent

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Go forward

Qualification course CMC-Specialist in Regulatory Affairs

Our modular qualification courses top seminars, felxible selection and cost savings.

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Qualification course CMC-Specialist in Regulatory Affairs
List of abbreviations

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