Project Management/Collection of Critical Documents for Chemistry, Manufacturing and Control (CMC) for Global Registration (CTD) & Incorporate Quality by Design within the CTD.
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 dossier to ROW regions including, LATAM, ASEAN, MENA and CIS territories.
You will increase your ability to manage all aspects of development of the CMC aspects of 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.
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 dossier, and links to GMP
Day 1 Schedule
- What is the CTD? The road map to Module 3 Understanding ICH
- Preparing the drug substance section of the application - US and EU
- GMP for Active Substances
- Case study: Essential information from API suppliers
- Examining the content of the sections concerning the drug product. Composition and development of the drug product ..
Day 2 Schedule
- Writing the section on manufacture of the drug product and process validation
- Writing the sections on Excipients and Packaging Components
- Writing the sections on control of the finished product and Case Study
- Writing the stability section
- The function and content of the Quality Overall Summary
- Examining Global Roll-out of CTD - Module 3
- Examining Change Control - Practical tips
- Practical Exercise in Generic Development
For more information about this conference visit http://www.researchandmarkets.com/research/22hqrq/common_technical