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
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
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
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
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
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…
Your speaker
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 various quality functions in CMC (including as CMC Expert Operations) and Change Control Management at Boehringer Ingelheim Pharma GmbH & Co. KG. Since October 2021, she has been leading the divisional CMC Writing Team, which deals with document creation for NCEs' API dossiers.
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…
Your speaker
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 of professional experience in the pharmaceutical industry, he founded his own consulting company in 2012.
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.…
Your speaker
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. From 2007 to 2010 she worked at Abbott as a manager in quality assurance. From 2010 to 2011she worked as a manager at Wilmar Schwabe in CMC and regulatory department. After this period she joined again Abbott from 2011 to 2017 again in quality assurance. From 2017 to 2023 she worked as a senior manager in CMC regulatory at Pharmalex.
Nora joined Boehringer Ingelheim in 2024 and has been working in the CMC Management Department as head of scientific CMC documentation DP. She and her team are responsible for the content of CMC documents (Module 3) of the regulatory submission documentation for Drug Product. The CMC documentation is harmonized across products and sites and complies with the latest scientific and regulatory findings.
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
from 09:00 am - 05:00 pm Online training
You may dial in 30 minutes before the session
09:00
09:15
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)
10:15
10:30
All experts
- CTD sections in detail
- Comparison between CMC for NCEs and generics
12:00
13:00
All experts
- CTD sections in detail
- Comparison between CMC for NCEs and generics
14:30
14:45
All experts
- Specific documents/sections which do not fit 100 % into CTD structure
- "Good vs bad" writing
- Case studies and exercises
15:45
All experts
- China, Japan, Brazil, South Africa, etc.
16:30
17:00
Welcome, expectations, introduction
09:15
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
10:30
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
Lunch break
13:00
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
14:45
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
15:45
Country specific CMC documents
Country specific CMC documents
All experts
- China, Japan, Brazil, South Africa, etc.
Summary and outstanding questions
End of seminar
Downloads
Request the documents using our form.
Brochure
Qualification_course_CMC-Specialist_in_Regulatory_Affairs
Weitere Informationen
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
Please visit our webpage Website
PreMeeting & Technical Test
Get to know our Learning Space and gain confidence: You can attend one of our
one of our PreMeetings free of charge, registration is not required. Dates and
access data for our PreMeetings can be found in your customer account. A PreMeeting offers
the opportunity to get to know our Learning Space better. It is a non-binding
offer for all customers and is not a prerequisite for your participation. If no date of a
PreMeeting does not suit you, but you would like a technical check in advance, please contact us.
please do not hesitate to 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
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Further Information
Qualification course CMC-Specialist in Regulatory Affairs
Our modular qualification courses top seminars, felxible selection and cost savings
List of abbreviations
Many abbreviations are used in all regulatory areas. Download the list of the most important ones.
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.
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