Learn how to compile this important section of your dossier to ensure faster turnarounds of submissions

LIVE ONLINE ACADEMIES

In light of the uncertain times we’re facing at the moment, gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.

Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-2 hours online.

All sessions will be recorded and uploaded to your virtual learning environment which you will get access to for a month. As part of this you will also be able to access a forum where you can communicate with your trainer and peers on the course.

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact [email protected].

The Quality and Pharmaceutical Module (Module 3) of the Common Technical Document (CTD) is a critical element of the submission process and must be navigated with skill to minimise delays. 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.

You will 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. Once completed you will have be able to compile and submit Module 3 (CTD) of your registration dossier, ensuring your dossier contains all the relevant data needed. You will also have the skill to submit the Module 3 quickly, speeding up the overall submission and approval process.

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

Regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.

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

28 April - 7 May 2020

New LIVE Online Academy

Learn how to compile this important section of your dossier to ensure faster turnarounds of submissions

LIVE ONLINE ACADEMIES

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

You may also be interested in...

Learn how to compile this important section of your dossier to ensure faster turnarounds of submissions

LIVE ONLINE ACADEMIES

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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