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.
New for 2020: This will be a blended learning experience, this means that you will receive a digital element containing additional reading and access to an online forum where you can interact with your teacher and peers. This will be made available to you 2 weeks before the course begins.
This course is also available for studying online, check website for dates>>
Two weeks before the course starts, delegates will be enrolled on to the online element of Introduction to Module 3 of the Global CTD Dossier course. Through this they will have access to:
Delegates will continue to have access to the online element, after the course has finished, for networking and development purposes.
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:
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.