Multiple Dates Available
Scheduled Digital
Preparing the Quality Module of the CTD
CTD Quality Mastery: Decoding Regulatory Expectations for Effective Drug Product Registration
CTD Pharma Training
Understanding and preparing the quality and pharmaceutical module of the global CTD Dossier
About the Course
Preparing the registration dossier for the Marketing Authorisation application is a critical milestone of drug development. This course focuses on key regulatory requirements for the content and structure of the quality module of the Common Technical Document (CTD Module 3).
This CTD course provides knowledge on the scientific data that are required on the quality of the drug product and helps you understand the expectations of regulatory authorities worldwide in terms of content and level of detail.
Who Should Attend
CTD training will be valuable to any person involved in the preparation of the CTD Module 3, as well as people from pharmaceutical development and/or production. For example:
- Regulatory affairs
- Regulatory CMC
- Quality assurance specialists
- Product scientists
- R&D pharmaceutical project managers
- Analytical and stability laboratory managers (from R&D to GMP)
- Production technical experts
Key Learning Objectives
- Understand the different levels of requirements in CMC during development and post-approval phase
- Get an overview of the structure of the CTD Module 3 and Quality Overall Summary (QOS)
- Understand the essential requirements for a drug substance and how to submit them
- Learn how to write the CTD sections on manufacturing and excipients
- Control on the finished product: learn how to set appropriate specifications and write the section
- Understand the requirements for packaging materials
- Get an overview of stability requirements
Run this course in-house
Informa Connect Academy’s customised training solutions have helped organisations deliver tailored learning in different languages to suit every requirement.
Bespoke training designed for your organisation only, combining traditional classroom setting, blended and online learning models
Next Courses
schedule Date | maps_home_work Delivery Type | person Trainer | language Language | ||
|---|---|---|---|---|---|
27 Jan 2025 Digital learning over 4 weeks Online / Modular | location_on Scheduled Digital Australia | Sophie Nageotte | English | AUD$2,495.00 | |
27 Jan 2025 Digital learning over 4 weeks Online / Modular | location_on Scheduled Digital Singapore | Sophie Nageotte | English | SGD$2,495.00 | |
05 May 2025 Digital learning over 4 weeks Online / Modular | location_on Scheduled Digital Australia | Sophie Nageotte | English | AUD$2,495.00 | |
05 May 2025 Digital learning over 4 weeks Online / Modular | location_on Scheduled Digital Singapore | Sophie Nageotte | English | SGD$2,495.00 | |
01 Sep 2025 Digital learning over 4 weeks Online / Modular | location_on Scheduled Digital Australia | Sophie Nageotte | English | AUD$2,495.00 | |
01 Sep 2025 Digital learning over 4 weeks Online / Modular | location_on Scheduled Digital Singapore | Sophie Nageotte | English | SGD$2,495.00 |
27 Jan 2025
Digital learning over 4 weeks, Online / Modular
location_onScheduled Digital
Australia
Language: English
Trainer: Sophie Nageotte
AUD$2,495.00
27 Jan 2025
Digital learning over 4 weeks, Online / Modular
location_onScheduled Digital
Singapore
Language: English
Trainer: Sophie Nageotte
SGD$2,495.00
05 May 2025
Digital learning over 4 weeks, Online / Modular
location_onScheduled Digital
Australia
Language: English
Trainer: Sophie Nageotte
AUD$2,495.00
05 May 2025
Digital learning over 4 weeks, Online / Modular
location_onScheduled Digital
Singapore
Language: English
Trainer: Sophie Nageotte
SGD$2,495.00
01 Sep 2025
Digital learning over 4 weeks, Online / Modular
location_onScheduled Digital
Australia
Language: English
Trainer: Sophie Nageotte
AUD$2,495.00
01 Sep 2025
Digital learning over 4 weeks, Online / Modular
location_onScheduled Digital
Singapore
Language: English
Trainer: Sophie Nageotte
SGD$2,495.00
Is this course for you?
Course Information
Instructional Delivery Method: Schedule Digital
Prerequisite & Advanced Preparation: Reading material will be sent prior to the course
Learn More About This Training Course
Delivered by Sophie Nageotte
Sophie has over 20 years of experience in the pharmaceutical industry. She gained her Master’s degree in analytical chemistry from Manchester University and her Chemical Engineer degree from Montpellier School of Chemistry.
Run this course in-house
Informa Connect Academy’s customised training solutions have helped organisations deliver tailored learning in different languages to suit every requirement.