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IPQ Monthly Update – June 2021 in Review

The four-part IPQ story in this issue explores the current dialogue on the drivers and pathways for a more collaborative, streamlined and globally-minded regulatory approach to combination products in Europe and the activity in progress to reach that goal. In focus in the four parts are: ● the EU Pharma Strategy roadmap, comments from industry, and related agency strategies ● culture/structure/process change and global alignment ● HPRA CEO Lorraine Nolan on HPRA and EMA strategy, and ● EMA’s Zaïde Frias and NB/industry perspectives on EU regulatory transformation.

IPQ Monthly Update – June 2021 in Review

A Confluence of Forces Is Now Spurring Combination Product Regulatory Reform in Europe

A confluence of forces is intensifying the pressure on and opening pathways to the reform of drug/device combination product regulation in Europe, with legislative changes and strategic priority needs at issue.

Part I: EU Pharma Strategy Roadmap, Comments from Industry, and Related Agency Strategies

Part II: Culture/Structure/Process Change and Global Alignment

Part III: HPRA CEO Lorraine Nolan on HPRA and EMA Strategy

Part IV: EMA’s Zaïde Frias and NB/Industry Perspectives on EU Regulatory Transformation

IPQ Monthly Update – May 2021 in Review

IPQ Monthly Update – April 2021 in Review

IPQ’s 2010-2021 Stories on PAC/QRM/KM Regulatory Dialogue

The following is a chronological listing of IPQ stories since 2010 that have covered the pressing issues around post-approval changes and what is needed in conjunction with advancements in risk and knowledge management to make quality regulatory processes across the product lifecycle more cohesive, efficient, process improvement and supply friendly, and internationally harmonized. 2010 ● […]

IPQ Monthly Update – April 2021 in Review

The feature story in the April issue explores how regulators and industry are working together to make quality risk management (QRM) a more effective force in improving quality systems and the regulatory communication process at the review and inspections levels. The three parts of the story provide insights from: ● HPRA’S Kevin O’Donnell on the evolution of QRM and the revision now underway of ICH’s 15-year-old QRM guideline Q9, which he is leading ● FDA’s Rick Friedman, also on the Q9 revision Expert Working Group, on advancing aseptic processes through QRM, and ● industry/academia thought leaders on evolving QRM’s relationship with knowledge management across the product lifecycle.

Regulators Are Exploring with Industry How to Strengthen Quality Risk Management Practices, with Revision of ICH Q9 a Key Focal Point

Regulators and industry are sitting down together to mine their experience and map out some clearer directions and expectations about what is needed to empower quality risk management (QRM) in improving the pharmaceutical quality system (PQS) and the industry/regulatory communication process at the review and inspection levels.

Part I: ICH Q9 Revision Lead O’Donnell on the Evolution of QRM

Part II: FDA’s Rick Friedman on Advancing Aseptic Processing through QRM

Part III: Industry/Academia Thought Leaders on the Evolving QRM/KM Relationship

IPQ Monthly Update – March 2021 in Review

IPQ Monthly Update – March 2021 in Review

The March issue provides a wealth of insights shared by FDA, EMA and PMDA biotherapeutic and vaccine regulators on the challenges, opportunities, and learnings as they have sought to support the accelerated product development and review called for by the pandemic, while assuring that CMC/quality standards are met and keeping up with their non-COVID-related workload. Included are updates on the guidances and other quality-related initiatives impacting vaccines and biotherapeutics that have been forthcoming during the first quarter of 2021.
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