2024-10-14 2024-10-14 , online online, 1,290 € plus tax Katrin Bräckow https://www.forum-institut.com/seminar/25022450-cmc-writing/referenten/25/25_02/25022450-online-seminar-pharma-cmc-writing_braeckow-katrin.jpg CMC Writing

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.

Topics
  • 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 NBEs and generics.
Aims and objectives
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!

Online-Seminar Pharma - CMC Writing

CMC Writing

- Online training -

Benefits
  • The essentials for beginners or refreshers
  • Practical tips and tricks
  • Considerations for NCEs and generics
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25022450

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

18/02/2025

18/02/2025

Period

9:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts

9:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts
Venue

online

online

Fee
Your contact

Dr. Birgit Wessels
Conference Manager

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

Details

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.

Topics

  • 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 NBEs and generics.

Aims and objectives

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!

Detailed programme

9:00 am - 5:00 pm - online seminar
You may dial in 30 minutes before the training starts

09:00 Welcome, expectations, introduction


09:15

All experts

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


10:30

All experts

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

12:00 Lunch break


13:00

All experts

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

14:30 Biobreak


14:45

All experts

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

15:45

All experts

Country specific CMC documents
  • China, Japan, Brazil, South Africa, etc.

16:30 Summary and outstanding questions


17:00 End of seminar


Our partner

Lexxion Verlagsgesellschaft mbH


More information

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

This distinguishes our events

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Qualification course CMC-Specialist in Regulatory Affairs

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List of abbreviations

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

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Abbreviations, Glossary
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality