2020-12-26 2021-10-27 , Online Online, 1.790,- € zzgl. MwSt. Jan-Jaap Scherpbier, MSc https://www.forum-institut.de/seminar/2110273-cmc-management-in-regulatory-affairs/referenten/21/21_10/2110273-online-training-pharma-cmc-management-in-regulatory-affairs_scherpbier,-msc-jan-jaap.jpg CMC Management in Regulatory Affairs

This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar via Zoom.

Topics
  • Regulatory requirements in the EU and the ICH region
  • Essential quality data for marketing authorisation
  • CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary
  • Management of post-approval changes
  • Classification of quality related variations
Aims and objectives
This online-training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region. Our experts will pass on their indepth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.
Who should attend

This seminar will particularly benefit CMC managers, regulatory affairs managers and quality assurance specialists dealing with
the

  • compilation and the maintenance of CTD Module 3 and/or the
  • classification of quality-related changes.

Online-Seminar CMC Management in Regulatory Affairs

CMC Management in Regulatory Affairs

- Online training -

Benefits
  • Detailed electronic documentation
  • First-hand information
  • Online training: Flexible, modern, interactive
  • Pose your individual questions in advance
  • We are following the IMI quality criteria

Webcode 2110273

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Referenten


Alles auf einen Blick

Termin

26. - 27.10.2021

26. - 27.10.2021

Zeitraum

Day 1: 9:00 am - 5:00 pmDay 2: 9:00 ...

Day 1: 9:00 am - 5:00 pm
Day 2: 9:00 am - 5:00 pm
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

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

Details

This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar via Zoom.

Topics
  • Regulatory requirements in the EU and the ICH region
  • Essential quality data for marketing authorisation
  • CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary
  • Management of post-approval changes
  • Classification of quality related variations
Aims and objectives

This online-training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region. Our experts will pass on their indepth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.

Who should attend

This seminar will particularly benefit CMC managers, regulatory affairs managers and quality assurance specialists dealing with
the

  • compilation and the maintenance of CTD Module 3 and/or the
  • classification of quality-related changes.

Detailed programme

Day 1: 9:00 am - 5:00 pm
Day 2: 9:00 am - 5:00 pm

09:00 Welcome and introduction


09:15

Jan-Jaap Scherpbier

Introduction to RA/CMC in EU in a nutshell
  • Legal framework
  • Introduction to submission
  • ICH requirements: Structure of the CTD

09:45

André Mota and Jan-Jaap Scherpbier

Quality data for marketing authorisation
  • Essential quality data for Module 3 Drug substance: From starting material to stability (re-test period) Drug product: From pharmaceutical development to stability (shelf-life)

10:45 Coffee break


11:00 Continuation: Quality data for the marketing authorization


12:30 Lunch break


13:30

André Mota and Jan-Jaap Scherpbier

Continuation: Quality data for the marketing authorization

14:45 Coffee break


15:00

André Mota and Jan-Jaap Scherpbier

CTD CMC documentation: Practical aspects
  • Pharmaceutical writing: Essential data vs. dossier maintenance burden
  • Quality Overall Summary (QOS)
  • Drug substance: How to avoid common mistakes?
  • Active Substance Master Files (ASMF), Certificate of Suitability (CEP)
  • Drug substance analysis by finished product manufacturer

17:00 End of day 1


09:00

Jan-Jaap Scherpbier

Challenges in the interdisciplinary field
  • GMP meets regulatory affairs Mandatory documents(QP-declaration, GMP certificates, process validation, etc.)
  • Non-clinical and clinical meets CMC

10:15 Coffee break


10:30

Dr Helmut Vigenschow

Management of post-approval changes
  • Lifecycle management (including global environment)
  • Variations Grouping, work-sharing Art 61(3)

12:45 Lunch break


13:45

Jan-Jaap Scherpbier

Case study: Evaluation of the CMC data
  • CTD relevance?
  • Requirements for a planned variation

15:00 Coffee break


15:15

Dr Helmut Vigenschow

Classification of quality-related variations
  • Interactive session Drug substance example Drug product example
  • Pitfalls/grey areas within regulations

16:45 Q&As and outstanding questions


17:00 End of training course


More information

Learning outcomes

- Knowledge of regulatory framework in Europe and the ICH region
- Ability to choose the essential quality data for drug substance and drug product section of Module 3
- CMC writing skills
- Background knowledge in interdisciplinary field: non-clinical, GMP and clinical meets CMC
- Familiarity with life cycle management in a global environment
- The ability to classify quality-related changes

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 during the seminar.
Please send your questions to: Dr. Birgit Wessels, b.wessels@forum-institut.de

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.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. 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

This distinguishes our events

Overall impression: 100 % of the participants feedback was very good or good (September 2019)

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Your feedback produced as result of 1.7 in 2020. Thank you!

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Testimonials

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Glenwood GmbH