• • The CMC review process
• – what reviewers want to see in applications and interactions
• • Preapproval and GMP inspections
• – what investigators are looking for and finding and how companies manage the process
• • Enforcement actions
• – what concerns are drawing follow up and where and how fast action is being taken
• • Process validation
• – how the lifecycle paradigm is changing manufacturer practice and investigator expectations
• • Analytical methods
• – how QbD is unleashing the power of analytical technology and reshaping the QC lab
• • Regulator/industry communication
• – the new linkages being formed and the new roles being defined to implement the advancing quality principles
• • Product/process development
• – how the QbD knowledge base is expanding what manufacturers can do and the regulatory flexibility they have to do it
• • Risk management
• – how and where RM is being used to improve product quality and control and regulator/industry interactions
• • Quality systems
• – how manufacturer and regulator practices are changing as QS thinking is embraced from drug development to supply chain control.
• • Knowledge management
• – the challenges industry and regulators face to accommodate the development and on-going improvement of increasingly complex processes and products
• • Supply chain
• – how the complexities of global ingredient, manufacturing and distribution networks are driving the search for cooperative solutions
• • Guidelines and standards
• – what is being achieved and proposed as the power of industry/regulator cooperation and international harmonization becomes better understood
• • Manufacturing changes
• – the strengthening of company quality systems and the clearing of the CMC regulatory pathway to advance technology, continuous improvement and biosimilars

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