2024-06-12 2024-06-12 , online online, 1,890 € plus tax Dr. Margit Schnee https://www.forum-institut.com/seminar/24112454-cmc-management-in-regulatory-affairs/referenten/24/24_11/24112454-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
  • 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 24112454

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

12-13/11/2024

12-13/11/2024

Period

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
Fee
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


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

Qualification course "CMC-Specialsist"

This seminar is the basic module of our qualification programme "CMC-Specialist".

The course concept:

  • You attend our basic course "CMC Management in Regulatory Affairs"
  • Afterwards you select and participate in 3 further seminar modules (= 3 seminar days), which you can put together individually from the course curriculum
  • You will receive structured further training and comprehensive knowledge on topics relating to CMC management
You can specialise according to your main field of interest through the targeted selection of seminars

Please visit our webpage Website

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

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

Recommendations

CMC dossier requirements for biologics: FDA vs EU

CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality d...

16.10.2024, Online
Details

GxP-Regulated Archiving

Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration...

24.09.2024, Online
Details
Masterclass China: Medical Device Marketing Authorisation for Advanced

Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable i...

10. - 11.09.2024, Online
Details

Biopharmaceuticals

The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place...

24. - 26.06.2024, Online
Details

Marketing Authorisation in Latin America

An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chi...

26. - 27.09.2024, Online
Details

Go forward

Whitepaper: The principles of post-approval change management

This whitepaper describes the principles of post-approval change management protocols (PACMP) and the related guideline ...

Details
Whitepaper: The principles of post-approval change management
Qualification course "CMC-Specialist"

Our modular qualification programmes: Top seminars, flexible selection and cost savings.

Details
Qualification course
We guarantee the highest quality

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

Details
We guarantee the highest quality