START-UP - SELECTION -
GOVERNANCE - DELIVERY
Participate in 2 days of high-level discussions around CMO challenges and expectations at every phase of operation.
Representatives from Contract Manufacturing and Development Organizations, Owner Companies, and the FDA, will assemble at the CMO Workshop to discuss regulatory and operational challenges associated with four phases of contract manufacturing operations. Through open discussion and debate, key activities covered at this workshop will include CMO related challenges such as roles and responsibilities and quality contracts.
- Examine every phase of the Owner-CMO relationship throughout the product lifecycle:
Start-up ♦ Selection ♦ Governance ♦ Delivery
- Explore roles and responsibilities of all parties involved in CMO activities
- Contribute to an ongoing dialogue facing all partners and constituents committed to successful manufacture and delivery of quality products
- Discuss challenges experienced by both Pharma and Generics Companies
- Understand important components of Quality Contracts being included in upcoming FDA guidance
- Interact in a workshop setting with Regulators and other executives from CMO and Owner Companies