Preparing the Chemistry and Pharmacy Section of the EU Registration Dossier

This 3-day course will provide you with a clear understanding of the European regulatory requirements for Module 3 (CTD) of your application, and will show you how to compile this important part of your submission dossier. The course sessions will also examine the impact of the Common Technical Document. 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 of 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.

• Compile and submit the Chemistry and Pharmacy section of your registration dossier
• Ensure all data needed has been collected
• Deal effectively with regulators
• Meet the legal framework and guidelines for the CMC/ Quality part of the dossier, and links to GMP
• Incorporate CTD requirements in your dossier
• Maintain your product after approval and manage changes
• Implement regulatory requirements for CMC variations