This event provides its participants access to other industry leaders and an environment to discuss process innovation and technology and safety perspectives for highly potent active pharmaceutical ingredient (HPAPI) manufacturers and outsourcers.
KEY PRACTICAL LEARNING POINTS
- EMA requirements and considerations
- Assuring regulatory compliance with the permitted daily exposure
- Avoiding major HPAPI project issues
- Dealing with containment challenges
- HPAPI facilities and process equipment design
- Cleaning validation as one driver to prevent cross-contamination
- How to ensure safe HPAPI handling?
- Enhance every stage of a potent compound development strategy
- How to improve safety and maximize manufacturing efficiencies for highly potent medicines
- The unique Challenges in the transfer of HPAPI processes