How to Prepare Module 3 of the Global CTD Dossier Training

This 3-day course will provide you with a clear understanding of the US and European regulatory requirements for Module 3 (CTD) of your application, and will show you how to compile this important part of your submission dossier. This course will teach you how to:

Compile and submit Module 3 (CTD) of your registration dossier
Ensure that Module 3 (CTD) of your dossier contains all data needed
Achieve the quickest turnaround for your submission
Deal effectively with regulators

Become more confident in your daily practices after three days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your dossier.

This course is also available for studying online, check website for dates>>

Build Module 3 (CTD) of the dossier to meet regulatory requirements
Understand the legal framework and guidelines for the CMC/Quality part of the dossier
Meet the legal responsibilities of the manufacturing authorisation holder, and the designated qualified person
Write the application with a view to product maintenance and consistent supply
Define the impact of the Common Technical Document on the Quality section of the dossier
Write variation submissions for Europe and get approval first time
Structure your submission teams to ensure compliance
Link your dossier requirements to GMP
Minimise delays in your submission by providing accurate documentation
Use certificate of suitability as replacement of data

Andrew Willis has over 28 years' of experience in regulatory affairs and pharmaceutical development with specific knowledge in EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products.

Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew now works as an independent Regulatory Affairs and Pharmaceutical Development Consultant.

This course has been specifically designed to address the needs of:

Regulatory Affairs Managers/ Officers/ Assistants
Compliance Managers
Documentation Managers
Product Registration Personnel
Project Managers in Regulatory Affairs
Qualified Persons
Key contributors to the submission package

Very useful information and tips. The course was interesting and useful as we worked with specific topics/questions in groups.

Regulatory Affairs Manager, Fresenius Kabi

Getting a deeper knowledge about 3.2. in Module 3 of the CTD was great. It was also good to be able to discuss with colleagues from other functions as well as with the trainer.

Module 3 of the Global CTD

19 - 21 June 2018

Radisson Blu Edwardian Grafton, London

How to Prepare Module 3 of the Global CTD Dossier Training

Very useful information and tips. The course was interesting and useful as we worked with specific topics/questions in groups.

Regulatory Affairs Manager, Fresenius Kabi

Getting a deeper knowledge about 3.2. in Module 3 of the CTD was great. It was also good to be able to discuss with colleagues from other functions as well as with the trainer.

Regulatory Affairs Specialist, Fresenius Kabi

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How to Prepare Module 3 of the Global CTD Dossier Training

Very useful information and tips. The course was interesting and useful as we worked with specific topics/questions in groups.

Regulatory Affairs Manager, Fresenius Kabi

Getting a deeper knowledge about 3.2. in Module 3 of the CTD was great. It was also good to be able to discuss with colleagues from other functions as well as with the trainer.

Regulatory Affairs Specialist, Fresenius Kabi

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