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Schedule 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

29 Jan 2024

33 days

Australia/Sydney

location_on

Scheduled Digital

Online

Sophie Nageotte

English

AUD$2,095.00

29 Jan 2024

33 days

Singapore

location_on

Scheduled Digital

Online

Sophie Nageotte

English

SGD$2,095.00

06 May 2024

33 days

Australia/Sydney

location_on

Scheduled Digital

Online

Sophie Nageotte

English

AUD$2,095.00

06 May 2024

33 days

Singapore

location_on

Scheduled Digital

Online

Sophie Nageotte

English

SGD$2,095.00

02 Sep 2024

33 days

Australia/Sydney

location_on

Scheduled Digital

Online

Sophie Nageotte

English

AUD$2,095.00

02 Sep 2024

33 days

Singapore

location_on

Scheduled Digital

Online

Sophie Nageotte

English

SGD$2,095.00

  • 29 Jan 2024

    33 days, Australia/Sydney

    location_on

    Scheduled Digital

    Online

    Language: English

    AUD$2,095.00

  • 29 Jan 2024

    33 days, Singapore

    location_on

    Scheduled Digital

    Online

    Language: English

    SGD$2,095.00

  • 06 May 2024

    33 days, Australia/Sydney

    location_on

    Scheduled Digital

    Online

    Language: English

    AUD$2,095.00

  • 06 May 2024

    33 days, Singapore

    location_on

    Scheduled Digital

    Online

    Language: English

    SGD$2,095.00

  • 02 Sep 2024

    33 days, Australia/Sydney

    location_on

    Scheduled Digital

    Online

    Language: English

    AUD$2,095.00

  • 02 Sep 2024

    33 days, Singapore

    location_on

    Scheduled Digital

    Online

    Language: English

    SGD$2,095.00

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.

Regulatory Affairs Specialist

Liqvor CJSC

“The course trainer was friendly and clearly very knowledgeable. I found the flexibility of the course and the structure very useful to fit around my schedule.”