CMC Management in Regulatory Affairs
Quality data for marketing authorisation in Europe
- Update on the new (Draft) ICH M4Q(R2)
- Detailed documentation with references to guidelines
- The basic module to become a "CMC-Specialist"
- Officially certified according to ISO 9001 + 21001
Online-Seminar
Ab
1.990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Both days: 09:00 am - 5:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts
Buchungsdetails
Online-Seminar
Ab
1.990,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.990,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
Both days: 09:00 am - 5:00 pm CET - Online training
You may dial in 30 minutes before the lecture starts
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Including an update on the new (Draft) ICH M4Q(R2) and the Draft of the Revision of the Classification Guideline. Take the chance to participate in our virtual seminar and get qualified.
Your speakers
Dr. Margit Schnee
CSL Vifor, SWITZERLAND
Senior Regulatory Affairs Manager CMC
Dr Schnee worked for several years at CureVac N.V. in non-clinical research on mRNA-based vaccines. Still at CureVac, she later switched to…
Your speaker
Dr. Margit Schnee
CSL Vifor, SWITZERLAND
Senior Regulatory Affairs Manager CMC
Dr Schnee worked for several years at CureVac N.V. in non-clinical research on mRNA-based vaccines. Still at CureVac, she later switched to RA CMC.
With her experience she moved to CSL in 2020. At CSL she has been working in Regulatory Affairs CMC as product responsible and recently became the lead for the non-biological products team in Regulatory
Affairs CMC.
Dr. Andrea Förster
pharmaand GmbH
Vienna, AUSTRIA
Head of CMC
Dr Andrea Förster has over a decade of experience in the pharmaceutical and chemical industry, with a strong focus on CMC, quality, and manufacturing. Her…
Your speaker
Dr. Andrea Förster
pharmaand GmbH
Vienna, AUSTRIA
Head of CMC
Dr Andrea Förster has over a decade of experience in the pharmaceutical and chemical industry, with a strong focus on CMC, quality, and manufacturing. Her professional path includes roles in development and production, including CMC analytics, supporting EU, U.S., and global markets. In 2024, she joined pharma& as Head of CMC, where she is responsible for the strategic direction and coordination of CMC activities across the product portfolio.
Dr. Martina Dressler
Teva GmbH,
Ulm, GERMANY
Change Control Manager
Dr Dressler is a licenced pharmacist with many years of experience in the parmaceutical industry at Teva ratiopharm, initially in RA Generic Maintenance and…
Your speaker
Dr. Martina Dressler
Teva GmbH,
Ulm, GERMANY
Change Control Manager
Dr Dressler is a licenced pharmacist with many years of experience in the parmaceutical industry at Teva ratiopharm, initially in RA Generic Maintenance and for more than 10 years in the GMP regulated environment in the area of Quality Assurance. She currently focuses on the Lifecycle Management of generics and biogenerics as well as the project management of change control applications.
What to Expect
- Regulatory requirements in the EU and the ICH region
- Update on the new (Draft) ICH M4Q(R2)
- 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.
Objective of the Event
This training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region.
Including an update on the new (Draft) ICH M4Q(R2), plus an overview on the Revision of the Classification Guideline.
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 lifecycle management in a global environment
- The ability to classify quality-related changes
Programme
Day 1: 9:00 am - 5:00 pm
Day 2: 9:00 am - 5:00 pm
Day 1
09:00
09:15
Dr Margit Schnee
- Legal framework
- Introduction to submission
- ICH requirements: Structure of the CTD
09:45
Dr Andrea Förster, Dr Margit Schnee
- 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
11:00
12:30
13:30
Dr Andrea Förster, Dr Margit Schnee
14:45
15:00
Dr Andrea Förster, Dr Margit Schnee
- 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
Welcome and introduction
09:15
Introduction to RA/CMC in EU in a nutshell
Introduction to RA/CMC in EU in a nutshell
Dr Margit Schnee
- Legal framework
- Introduction to submission
- ICH requirements: Structure of the CTD
09:45
Quality data for marketing authorisation
Quality data for marketing authorisation
Dr Andrea Förster, Dr Margit Schnee
- 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)
Coffee break
Continuation: Quality data for the marketing authorization
Lunch break
Continuation: Quality data for the marketing authorization
Coffee break
15:00
CTD CMC documentation: Practical aspects
CTD CMC documentation: Practical aspects
Dr Andrea Förster, Dr Margit Schnee
- 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
End of day 1
Day 2
09:00
Dr Margit Schnee
- GMP meets regulatory affairs
- Mandatory documents (QP-declaration, GMP certificates, process validation, etc.)
- Non-clinical and clinical meets CMC
10:15
10:30
Dr Martina Dressler
- 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
13:45
Dr Margit Schnee
- CTD relevance?
- Requirements for a planned variation
15:00
15:15
Dr Martina Dressler
- Interactive session on various variation types
- Drug substance example
- Drug product example
- Pitfalls/Grey areas within regulations
16:45
17:00
09:00
Challenges in the interdisciplinary field
Challenges in the interdisciplinary field
Dr Margit Schnee
- GMP meets regulatory affairs
- Mandatory documents (QP-declaration, GMP certificates, process validation, etc.)
- Non-clinical and clinical meets CMC
Coffee break
10:30
Management of post-approval changes
Management of post-approval changes
Dr Martina Dressler
- Regulatory processes dependent on variation type
- Grouping/Worksharing processes
- Art 61 (3)
- Company internal CMC-related change processes
- Lifecycle Management (ICH Q12, Q14)
Lunch break
13:45
Case study: Evaluation of the
CMC data
Case study: Evaluation of the CMC data
Dr Margit Schnee
- CTD relevance?
- Requirements for a planned variation
Coffee break
15:15
Classification of quality-related variations
Classification of quality-related variations
Dr Martina Dressler
- Interactive session on various variation types
- Drug substance example
- Drug product example
- Pitfalls/Grey areas within regulations
Q&As
End of training course
Downloads
Request the documents using our form.
Brochure
Abbreviation list_Drug Regulatory Affairs and CMC
Weitere Informationen
Qualification course "CMC-Specialist"
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 is what distinguishes this event
Overall impression: 100 % of the participants feedback was very good or good (September 2019)
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Further Information
Whitepaper: CMC Management in Regulatory Affaris - From the CMC Manager‘s erveryday business life
Struggling with Module 3 compliance?
Incomplete or incorrect CMC data can cause costly delays in regulatory approvals.…
Qualification course "CMC-Specialist"
Our modular qualification programmes: Top seminars, flexible selection and cost savings.
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Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de