Navigating CMC Requirements During Drug Development and Post-Approval
This training will not only offer you the overview of the existing regulatory aspects of the CMC, but it will also give you a proper understanding on how to face the challenges during the drug development and its post-approval.
What you will learn
- Overview of Global development process and guidance
- Drug substance requirements from manufacturing to preformulation studies and analytical validation
- Drug product specification and stability
- Lifecycle management
Who should attend?
- Quality assurance and compliance experts
- CMC and manufacturing personnel
- Regulatory affairs professionals
At the conclusion of this course, participants will be able to:
- Understand the guidelines proposed by FDA/EMA/WHO and ICH
- Learn the CTD structure and the alternative submission type for CMC documentation
- Identify the differences between IND/IMPD requirements in EU and US
- Assess the drug manufacturing requirements
- Be prepared for inspections
Learning objectives will be achieved using a mix of trainer presentations, trainer-led plenary discussions and case studies.
Plan Your Team's Professional Development
Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:
- Cost Effectiveness
For more information please contact EMEA@DIAglobal.org