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

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

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

21 - 23 October 2019

Radisson Blu Edwardian Grafton, London

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

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

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...

Regulatory Affairs Strategies

Regulatory, Developmental and Manufacturing Challenges for ATMPs

Pharmaceutical Regulatory Affairs in China

Regulatory Affairs Risk Management

US-FDA Drug Submission Procedures

Preparing the Quality Module of the CTD

NEW ON-DEMAND TRAINING LIBRARY

Regulatory Information Management and IDMP Training

Project Management for Regulatory Affairs Professionals

eCTD Submissions

GDPR and Data Protection in the Pharmaceutical Industry

Regulatory Affairs in Latin America

Introduction to EU Regulatory Affairs

Challenges in Drug/Device Combination Products

Regulatory Affairs for Clinical Trials

Fundamentals of EU Regulatory Affairs

Introduction to Regulatory Affairs in the MENA Region

Gaining Marketing Authorisations in CIS for Pharmaceuticals and Biotech

EU & US Requirements for Pharmaceutical Labelling & Package Leaflets

Mastering Regulatory and Development Strategies for Generics

Examining the Q3D Guideline on Elemental Impurities

Fundamentals of Clinical Trials Regulations

PTI Course Calendar

Advanced European Regulatory Affairs

Filing Variations