Quality Systems and Regulatory

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

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 session focuses on Advancing Pharmaceutical Quality (APQ) and specifically the APQ Quality Maturity Framework that has been developed by ISPE over the past 3 years evolving from ISPE’s research in response to FDA Quality Metrics draft guidance and ISPE’s Cultural Excellence report.  This industry-for-industry quality maturity framework provides an Assess, Aspire, Act and Advance model for quality management maturity.  In this session, industry experts will provide the APQ Quality Management Maturity Framework and will provide their learnings from the

This session will explore how both industry and regulatory authorities have adapted to manage our governance responsibilities during the COVID-19 pandemic when travel was restricted, and resources of many types were scarce.  We will discuss the Lessons we have Learned – what worked, what didn’t work so well, and what we feel is valuable to take forward as we move into the “new normal” with more remote work.  Speakers will represent a global perspective including the cross-industry collaboration on the IFPMA paper on Virtual Inspections, results from the E

This session features industry members from active ICH working groups providing insights on four important documents.  Three of these documents will be available for Step 2 Public Comment in the fall of 2021.  Don’t miss the opportunity to get insights from the industry experts who developed the text in the documents as you prepare to review and provide comments on ICH Q2(R2) Analytical Method Validation, ICH Q14 Analytical Method Development, and ICH Q9(R1) Quality Risk Management.  You will also hear about implementation progress on ICH Q12 Lifecyc