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