CMC writing excellence: From development data to CTD content

Structure, language and best practices of quality-related documents

  • Two experts share their extensive regulatory experience
  • Best practices, real-world examples
  • Provide your individual questions prior to the course
  • Certified according to 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

Would you like to feel more confident presenting your CMC/quality data clearly and in full compliance with regulatory standards? Our two experts will share their extensive regulatory expertise in "advanced" CMC writing with you, providing you with real-world examples and practical tools.

Your speakers

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…

Dr. Helmut Vigenschow

Dr. Helmut Vigenschow

ViPharmaService,
Burgrieden

Independent Consultant
Dr Vigenschow worked for Merckle/ratiopharm for 30 years in leading positions, including in the areas of project management, regulatory affairs,…

What to Expect

  • CMC writing conventions
  • Pharmaceutical development
  • Description of the manufacturing process and of analytical procedures
  • GMP aspects and CMC content
  • The quality part of the IND/IMPD along pre-/clinical development
  • Working with service providers and compilation of the CTD

Who Should Attend

Experts writing and reviewing international CMC documents will particularly benefit from this training.
It addresses the needs of those who desire to deepen their knowledge, especially on structural and conceptional details.

Participants should have prior knowledge of the content and structure of module 3.

The focus is on drug products with chemically synthetised active substances.

Objective of the Event

Our comprehensive training program equips you with practical tools and expertise to confidently prepare CMC documents for CTD submission, with a strong focus on language, structure, and concept.

Following an introduction to general conventions in CMC writing our experts will guide you through considerations for creating the development plan, including specific aspects for different dosage forms: solid, liquid and sterile products.
You will learn how to compile the description of the manufacturing process correctly and receive best practices for working with service providers. You'll also gain valuable insights into the creation of CTD submissions, benefiting from real-world examples and extensive regulatory experience.

Upon completion of this seminar, you will be able to present your data clearly and in full compliance with regulatory standards, ensuring consistency and logical flow that facilitates regulatory review and approval.

Your Benefit

After having participated in the compact course, you as "advanced" CMC writer will have learned how to

  • create the development plan;
  • how to compile the description of the manufacturing process;
  • how to work with service providers;
  • how to handle the quality part of the IND/IMPD;
  • how to create CTD-submissions.

This approach enables you to present data clearly in full regulatory compliance, maintaining consistency and logical flow that expedites regulatory review and approval.

Programme

from 9:00 am until 5:00 pm CET

Welcome, introduction, expectations

CMC writing conventions
Dr Helmut Vigenschow
  • Appropriate language (German and English)
  • How to integrate citations, images, tables, annexes, abbreviations?

Bio break

Pharmaceutical development
Dr Hans Rensland and Dr Helmut Vigenschow
  • Creation of a logical structure
  • Responsibilities: who writes, who proofreads?
  • Pharmaceutical development section step by step
  • Describing QbD aspects QTPP, CQA, CPP, CMA in pharmaceutical development sections
  • How can active ingredient overages, preservatives and antioxidants be justified?
  • Specific considerations for solids, liquids and steriles
  • High level: considerations for Drug Device Combination products (DDCs)

Lunch break

Description of the manufacturing process and analytical procedures
Dr Helmut Vigenschow and Dr Hans Rensland
  • API manufacturing description according to CMC and GMP
  • API manufacturing in the applicants and in the restricted part of an ASMF
  • Describing manufacturing processes of drug products
  • Development of the control strategy
  • The analytical target profile
  • Description of the analytical methods
  • Structure of specifications
  • Integration of validation results into the CMC dossier

Bio break

GMP aspects and CMC content
Dr Helmut Vigenschow
  • Presentation and evaluation of stability data
  • Editing of deficiency reports

The quality part of the IND/IMPD along preclinical and clinical development
Dr Hans Rensland

Working with service providers and compilation of the CTD
Dr Hans Rensland
  • Considerations for compliant outsourcing
  • Use of helpful tools e.g. software
  • Tips and tricks, avoiding pitfalls

Summary and outstanding questions

End of seminar

Welcome, introduction, expectations

CMC writing conventions

Dr Helmut Vigenschow

  • Appropriate language (German and English)
  • How to integrate citations, images, tables, annexes, abbreviations?

Bio break

Pharmaceutical development

Dr Hans Rensland and Dr Helmut Vigenschow

  • Creation of a logical structure
  • Responsibilities: who writes, who proofreads?
  • Pharmaceutical development section step by step
  • Describing QbD aspects QTPP, CQA, CPP, CMA in pharmaceutical development sections
  • How can active ingredient overages, preservatives and antioxidants be justified?
  • Specific considerations for solids, liquids and steriles
  • High level: considerations for Drug Device Combination products (DDCs)

Lunch break

Description of the manufacturing process and analytical procedures

Dr Helmut Vigenschow and Dr Hans Rensland

  • API manufacturing description according to CMC and GMP
  • API manufacturing in the applicants and in the restricted part of an ASMF
  • Describing manufacturing processes of drug products
  • Development of the control strategy
  • The analytical target profile
  • Description of the analytical methods
  • Structure of specifications
  • Integration of validation results into the CMC dossier

Bio break

GMP aspects and CMC content

Dr Helmut Vigenschow

  • Presentation and evaluation of stability data
  • Editing of deficiency reports

The quality part of the IND/IMPD along preclinical and clinical development

Working with service providers and compilation of the CTD

Dr Hans Rensland

  • Considerations for compliant outsourcing
  • Use of helpful tools e.g. software
  • Tips and tricks, avoiding pitfalls

Summary and outstanding questions

End of seminar

Downloads

Request the documents using our form.

Abbreviation List_Regulatory Affairs_CMC

Weitere Informationen


Modular qualification course CMC-Specialist

This seminar can be taken as elective module as part of our qualification program to become a CMC-Specialist.

The course concept:

  • You attend our basic course "CMC Management in Regulatory Affairs".
  • Then you choose and take part in 3 further seminar modules (= 3 seminar days), which you put together individually from the course plan.
  • You receive a structured further training and comprehensive knowledge in CMC management topics.
  • You can specialise according to your main area of business activity by selecting the seminars specifically.

For more information, please visit our Website


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.


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


Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.


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.

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

Whitepaper: Stability Testing of Drug Products - Focus: EU and ICH Requirements

Stay ahead of proposed regulatory changes in pharmaceutical stability testing. This "practical guide" helps you navigate…

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Modular qualification course CMC-Specialist

This seminar can be taken as elective module as part of our qualification program to become a CMC-Specialist.

Details

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