This interactive two-day course will provide you with a clear and comprehensive understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of the EU and USA. Furthermore, the course examines the requirements for global roll-out of the dossier to ROW regions including LATAM, ASEAN, MENA and CIS territories.
You will increase your ability to manage all aspects of the development of the CMC applications after two days of intensive lectures, group work and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy section of your generic dossier.
Skills you will gain include:
- Effective compilation of the Common Technical Document (CTD) and critical review of documentation
- Quality by design (QbD), 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 and quality aspects of your developments and registration dossier in Europe and the US
- Ensuring right-first-time development
- Meeting the legal framework and guidelines for the CMC/quality part of the dossier and links to GMP
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Course Content
Day 1
What is the CTD?
The importance of chemistry/manufacturing and controls (CMC)
A deep-dive in Module 3 - examining the content of all sections
Post-approval maintenance
Potential scenario for Module 3
Basic principles for eCTD authors (incl. focus on global dossier roll-out)
Trends, developments and future outlook
