CMC Writing

The essentials - with practical examples and exercises

  • The essentials for beginners or refreshers
  • Practical tips & tricks
  • Considerations for NCEs & generics
  • "Global requirements", e.g. China, Japan, Brazil
  • Officially certified: ISO 9001 + 21001

Online-Seminar

From 1.290,00 € plus VAT
Services & Process

Booking details

Online-Seminar

From 1.290,00 € plus VAT
Services & Process

You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.

Your speakers

Katrin Bräckow

Katrin Bräckow

Boehringer Ingelheim Pharma GmbH & Co. KG,
Ingelheim am Rhein, Germany

Head of Scientific CMC Documentation Drug Substance & Customer Services
Until October 2021, Anne Katrin Bräckow initially held…

Nora Wild

Nora Wild

Boehringer Ingelheim Pharma GmbH & Co. KG,
Ingelheim am Rhein, GERMANY

Head of Scientific CMC Documentation DP
Nora is a biologist. Her professional career started by a consultancy in Germany in 2004.…

Dr. Hans Rensland

Dr. Hans Rensland

RACON Regulatory Affairs Consulting GmbH, Heidelberg/Berlin, GERMANY

Independent Consultant
Dr Hans Rensland has 30 years of experience in clinical research and regulatory affairs. With his many years…

What to Expect

  • Structure and presentation of Module 3 and Module 2
  • CTD sections in detail: S-Part, P-Part, specific sections
  • Country specific requirements, e.g. China, Japan, Brazil, etc.
  • Considerations for NCEs and generics
  • Case studies and exercises

Who Should Attend

This training will particularly benefit those writing and reviewing international CMC documents.
It addresses the needs of those who are new in the field or desire to refresh their knowledge.

Participants should have prior knowledge of the content and structure of Module 3 and the Quality Overall Summary.

The focus is on NCEs and generics.

Objective of the Event

Our training will provide you with practical tools to help you become more comfortable writing the CTD's CMC documents.

After an introduction on the general structure and presentation of CMC documents in Module 3 and Module 2, our experts will dive deeper into different relevant CTD sections sharing practical examples and their experiences with you.

You will learn about the specific requirements for NCEs and generics.
Furthermore our experts will address details on country specific CMC documents.

After attending the seminar you will be able to present data clearly and in compliance with the regulations, and you will be able to sew a "golden thread" through your CMC documents.

Your Benefit

Profit from the in-depth know-how and the practical examples that our four experts will share with you!
Develop a guideline to efficiently manage the challenges in your own daily business!
Feel more secure writing CMC documents!

Programme

9:00 am - 5:00 pm CET - Online training

Welcome, introduction, expectations

General considerations: Structure and presentation of CMC documentation in Module 3 and Module 2
All experts
  • General documentation preparation/generation process
  • CTD structure (Module 3 + 2)
  • General considerations on CMC writing (e.g. cross-links between sections); consistent and compliant CMC documents
  • Outlook and current developments (CTD structure)

Biobreak

Deep dive into Module 3 and the Quality Overall Summary - S-Part
All experts
  • CTD sections in detail
  • Comparison between CMC for NCEs and generics

Deep dive into Module 3 and the Quality Overall Summary - P-Part
All experts
  • CTD sections in detail
  • Comparison between CMC for NCEs and generics

Biobreak

Specific CMC sections and case studies
All experts
  • Specific documents/sections which do not fit 100 % into CTD structure
  • "Good vs bad" writing
  • Case studies and exercises

Country specific CMC documents
All experts

Summary and outstanding questions

End of seminar

Welcome, introduction, expectations

General considerations: Structure and presentation of CMC documentation in Module 3 and Module 2

All experts

  • General documentation preparation/generation process
  • CTD structure (Module 3 + 2)
  • General considerations on CMC writing (e.g. cross-links between sections); consistent and compliant CMC documents
  • Outlook and current developments (CTD structure)

Biobreak

Deep dive into Module 3 and the Quality Overall Summary - S-Part

All experts

  • CTD sections in detail
  • Comparison between CMC for NCEs and generics

Deep dive into Module 3 and the Quality Overall Summary - P-Part

All experts

  • CTD sections in detail
  • Comparison between CMC for NCEs and generics

Biobreak

Specific CMC sections and case studies

All experts

  • Specific documents/sections which do not fit 100 % into CTD structure
  • "Good vs bad" writing
  • Case studies and exercises

Country specific CMC documents

Summary and outstanding questions

End of seminar

Downloads

Request the documents using our form.

Qualification course CMC Specialist in Regulatory Affairs

Further Informations


In-house seminars: Advanced training tailor-made!

You are looking for this topic for several employees?
We offer the right solution at your site or in virtual format!

We also offer this seminar as an in-house seminar.

Take advantage of the proven concepts of our open seminars and bring your employees to the same level of knowledge quickly and easily.

We will be happy to send you a non-binding offer.


Modular qualification training course

This course can be choosen as an elective module within the modular qualification course "CMC-Specialist in Regulatory Affairs".

The concept:

  • First you visit the mandatory module "Der CMC-Manager in Regulatory Affairs"
  • Further you choose another three elective modules (= three training days) dealing with CMC related topics from our portfolio
  • Thus you receive a structured training in CMC/Regulatory Affairs topics
  • Thus you are able to qualify yourself individually according to your focus of activities

For more information please visit our Website


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.


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

In-house Offers - On-site and Online

We also conduct this seminar exclusively for your company - individually tailored to your requirements, flexible scheduling and available as either on-site or online format. Contact us and we will prepare a customized offer for you.

Request a quote

Our Recommendations

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Further Information

Qualification course CMC-Specialist in Regulatory Affairs

Qualification course CMC-Specialist in Regulatory Affairs

Our modular qualification courses top seminars, felxible selection and cost savings

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List of abbreviations

List of abbreviations

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

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Our rating in 2025

Our rating in 2025

More than 3,700 customers have rated our training courses. Thank you for awarding us 4.4 stars out of 5.

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Your Contact Person

We are happy to advise you personally and individually.

Our further education offerings are comprehensive. We are happy to personally match your requirements with our offerings. Let our further education experts advise you and contact us today.
Dr. Birgit Wessels

Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de