2024-12-22 2024-12-22 , online online, 1,990 € zzgl. MwSt. Dr. Margit Schnee https://forum-institut.de/seminar/25052456-cmc-management-in-regulatory-affairs/referenten/25/25_05/25052456-online-training-pharma-cmc-management-in-regulatory-affairs_schnee-margit.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 and get qualified.

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

Who should attend

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

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

Aims and objectives

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

The content focus is on small molecules, biologics will be addressed during another event, see seminar recommendation.

Your benefit

Your learning outcomes after having participated:

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

Here are a few comments from last year's participants:

"I liked in partictular the insights about the CMC submissions."
"The seminar was very enlighting, lot of information that has to sit a bit, in overall the materialis about the guidlines were very helpful."
"Very useful, complex but well structured."
"I was aware of a few topics but still received so many new information, which was good. BPA manufacturing/specificatioin in particular was very interesting."

CMC Management in
Regulatory Affairs

- Online training -

Benefits

The basic module to become a "CMC specialist"
Detailed documentation with references to guidelines
Pose your individual questions in advance
Officially certified according to ISO 9001 and 21001

Webcode 25052456

Jetzt buchen

JETZT Buchen

Referenten

Alles auf einen Blick

Termin

22-23/05/2025

Zeitraum

Both days: 09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

Veranstaltungsort

online

Downloads

Gebühr

Your contact

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 and get qualified.

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

Who should attend

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

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

Aims and objectives

Your benefit

Your learning outcomes after having participated:

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

Here are a few comments from last year's participants:

"I liked in partictular the insights about the CMC submissions."
"The seminar was very enlighting, lot of information that has to sit a bit, in overall the materialis about the guidlines were very helpful."
"Very useful, complex but well structured."
"I was aware of a few topics but still received so many new information, which was good. BPA manufacturing/specificatioin in particular was very interesting."

Detailed programme

Both days: 09:00 am - 5:00 pm - seminar
You may dial in 30 minutes before the training starts

09:00 Welcome and introduction

09:15

Dr. Margit Schnee

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 Dr Margit Schnee

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