NA23CEOCT1/SES115 - Global Harmonization to Advance Innovation

This session will focus on global regulator harmonization Initiatives that advance global application approvals of innovative products, technologies, and modalities. Decisions to pursue and implement pharmaceutical innovations are frequently based on receptivity from global regulatory authorities. Lack of regulatory convergence can hinder innovation and continual improvement and increase the risk of drug shortages. In recent years, several opportunities have emerged to address some of the regulatory challenges that have been a barrier to manufacturing innovation, including:

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• Improvements in risk-based regulatory assessments of applications    
• Increased opportunities for direct engagement with regulatory authorities to align on application expectations and standards for new technologies    
• Expanded mechanisms for collaborative regulatory review/assessment of applications between regulatory authorities    
• Application of relevant learnings from the response to the COVID-19 pandemic toward increased adoption of mutual reliance/mutual recognition between regulatory authorities    
• New technologies to improve product reliability, local access, and sustainability

The culmination of circumstances has led several regulator-only organizations to initiate forward-looking programs toward harmonization of product quality reviews and inspections. This session will describe the existing hurdles to be reconciled to improve global regulatory harmonization for innovative technologies and the programs established to build trust and alignment between regulators. The content from presentations from key regulatory authorities and industry leaders will serve as the basis of an integrated panel discussion.

1530 – 1600: Barriers to Innovation:  Preliminary Results from ISPE Survey by Roger Nosal
1600 – 1620: ICMRA Collaborative Pilots: Vision and Achievements Leading to Regulatory Alignment and Efficiencies in Global CMC Assessment and Inspection Activities by Susan Polifko
1620 – 1640: PIC/S Perspective: Considerations on Harmonization and Innovation by Paul Gustafson
1640 – 1700: Question and Answer/Panel Discussion moderated by Christine Moore (with Bob Iser to join)