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
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
9:00 am - 5:00 pm CET- Online training
You may dial in 30 minutes before the lecture starts
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
Veranstaltung - 1.290,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
9:00 am - 5:00 pm CET- Online training
You may dial in 30 minutes before the lecture starts
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
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
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)
All experts
- CTD sections in detail
- Comparison between CMC for NCEs and generics
All experts
- CTD sections in detail
- Comparison between CMC for NCEs and generics
All experts
- Specific documents/sections which do not fit 100 % into CTD structure
- "Good vs bad" writing
- Case studies and exercises
All experts
Welcome, introduction, expectations
General considerations:
Structure and presentation of CMC documentation in Module 3 and Module 2
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
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
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
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
Our Recommendations
Further Information
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





