2023-09-26 2023-09-26 , online online, 1,790 € plus tax Dr. Margit Schnee https://www.forum-institut.com/seminar/23102452-cmc-management-in-regulatory-affairs/referenten/23/23_10/23102452-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

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 23102452

Book now

JETZT Buchen
Speakers

Dr. Margit Schnee

CSL Vifor, Switzerland

Regulatory Affairs Manager CMC

André Mota

ASPHALION S.L., Madrid Office, Spain

Regulatory Affairs Director, Madrid Office André has more than 14 years' experience in CMC Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different countries, with several types of products, and for different types of companies. Besides his core CMC expertise, he is mainly focused on CMC writing and strategic guidance, he has also been deeply involved in other relevant areas, such as: - Project lead/management of global projects, - Implementation of EMA Policy 0070 (clinical data transparency), and - eCTD publishing.
More information please click here.

Dr. Helmut Vigenschow

ViPharmaService, Burgrieden

Independent Consultant

Everything at a glance

Appointment

24-25/10/2023

24-25/10/2023

Period

Both days: 09:00 am - 5:00 pm - semi...

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

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

online

online

Downloads
BROCHURE
BROCHURE
Fee

Event - 1,790 € plus tax
The fee includes course documentation for download and a certificate.
SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €

Event - 1,790 € plus tax
The fee includes course documentation for download and a certificate. SPECIAL OFFERS
e-Learning: Stability Testing in the ICH Region
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €
e-Learning: CTD Module 3
, online
Simply register for the seminar and receive a €50 discount on the e-learning programme (€340 + local VAT rather than €390 € + local VAT) if you book it simultaneously.
340,00 €

Book now

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

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

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


13:30

André Mota and Dr Margit Schnee

Continuation: Quality data for the marketing authorization

14:45 Coffee break


15:00

André Mota and Dr Margit Schnee

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

Dr Margit Schnee

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
  • Regulatory processes dependent on variation type
  • Grouping/Worksharing processes
  • Art 61 (3)
  • Company internal CMC-related change processes
  • Lifecycle Management (ICH Q12, Q14)

12:45 Lunch break


13:45

Dr Margit Schnee

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 on various variation types Drug substance example Drug product example
  • Pitfalls/Grey areas within regulations

16:45 Q&As and outstanding questions


17:00 End of training course


Our partner

ASPHALION

Asphalion is an international Scientific and RA consultancy company. Founded in 2000, Asphalion offers comprehensive services for Drug Development and RA to Pharma, Biotech and Medical Devices companies. The services range from early development, throughout the registration, until marketing and post-commercialization phases of a product.



More information

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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Whitepaper: The principles of post-approval change management
List of abbreviations

Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

Details
Abbreviations, Glossary
Quality guaranteed!

Your feedback produced as result of 1.8 in 2022. Thank you!

Details
More on our quality criteria