Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for a successful developement, registration, and lifecycle of pharmaceutical products.
The course covers general requirements for small molecules and biologics.
- Different levels of requirements in CMC during development and post-approval phase
- Overview of challenges for post-approval CMC changes
- Understand what are the essential requirements for a drug substance
- Overview of stability requirements
- Understand the requirements for packaging
Who should attend?
- Quality assurance specialists
- Regulatory Affairs CMC authors or reviewers
- Analytical and stability laboratory managers (R&D through GMP)
- Project managers with CMC
- Chemistry, Manufacturing & Controls (CMC) regulatory
- Product scientists and test method technical experts (R&D and QC)
- Process analytical chemists and process development scientists