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2021 ISPE Annual Meeting & Expo

Concurrent Session: Path to a Global Quality Dossier - Part 2


Nov 1, 2021 3:00pm ‐ Nov 1, 2021 4:30pm


Description

Concurrent Session: Path to a Global Quality Dossier - Part 2|Industry has observed vastly different and region-specific CMC submission requirements and quality standards which can cause delays in approval of new medicines to patients worldwide.  A related challenge is the differing global Post Approval Change requirements that can risk continuity of supply of medicines.  The ideal state is a global quality dossier that can be assessed by multiple regulators and provides for a single, approved dossier that is globally maintained.  This would allow faster access of medicines to patients around the world, reduce the risk of supply shortages, help resource constrained regulators to rely on each other’s expertise and provide less regulatory burden to industry.  ICH Quality guidelines provide a firm foundation, and ICH Q8-Q12 outline key principles that cover product development by incorporating principles of risk assessments, pharmaceutical quality systems, and lifecycle management. In this two-part session, key aspects of a potential path to a global quality dossier will be presented.  Part 2 presentations will explore patient centric approach to post approval changes and how structured quality data combined with analytics can facilitate consistent and faster regulator assessment.  Part 2 will also include a panel discussion and Q&A with all of the presenters from both Part 1 & Part 2.

Session Leader(s):

  • Gregory Rullo, Senior Director, Regulatory Affairs-CMC, AstraZeneca Pharmaceuticals

Speaker(s):

Panelist(s):

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