This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for global roll out of the document to ROW regions including, LATAM, ASEAN, MENA and CIS territories.
You will increase your ability to manage all aspects of development of the CMCapplications after two days of intensive lectures, group work, and discussion session, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.
This course will cover the following topics:
- Effective compilation of CTD and critical review of documentation
- Quality by design, critical attributes and developing new product using the CQA pyramid model
- Compiling and submitting Module 3 (CTD) of your registration dossier
- Identifying the extent of content expected by EU and US regulators
- Achieving the quickest turnaround of your submission
- Managing the pharmaceutical development and quality aspects of your developments and registration dossier in Europe and US
- Ensuring right first time development
- Meeting the legal framework and guidelines for the CMC/quality part of the document, and links to GMP