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>>
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.