Education Sessions

PQLI Global Update (103 and 104)

Part 1 (103), 28 October 08.15-11.30
Part 2 (104), 28 October 14.15-17.15

(PDF Current as of 17 October 2008)

ISPE CEUs: 0.2 for each

ISPE's Product Quality Lifecycle Implementation (PQLI) program is an industry-driven initiative designed to develop a practical and pragmatic approach to improving industry product realization and manufacturing performance.
Focused initially on implementing Q8, Q9, and Q10 ICH guidance documents, PQLI provides the link between these ICH guidelines and the needs of those implementing them.

PQLI helps craft a pragmatic approach to implementing Q8, Q9 and Q10, using a risk-based approach to the lifecycle of a product – from regulatory submission to end-of-life. The PQLI program provides a technical framework for the application of manufacturing sciences throughout the industry, for example illustrating best practice implementation of Quality by Design (QbD) based on sound scientific, engineering, and business principles. Uniquely, PQLI involves worldwide regulators in the development and implementation of this critical thinking.

This session is divided into two parts. Part One will provide an overview of PQLI, progress made to date, and a rare opportunity to hear both reviewers' and inspectors' perspectives from all three ICH regions. The session will conclude with the unveiling of future plans for PQLI, with an opportunity for the audience to comment and shape its future direction and focus. Part Two commences with a presentation on how PQLI topics can be applied to currently marketed drugs, followed by perspectives for generic products. A lively question and answer segment with all regulatory participants closes the session.

Focus for Part 1 (103)

Overview of PQLI and Integration Concept
Implementation of Q8, Q9 and Q10: Regulatory Perspectives from the 3 ICH Regions
Pathway Forward

Focus for Part 2 (104)

Legacy Products
Generics
Regulatory Panel Discussion - USA, Europe, and Japan

How You Will Benefit

At the end of this session, participants will be able to:

Understand the views of senior regulators from USA, Europe, and Japan
Help formulate your future by participating in this global initiative
Understand how design space, criticality, control strategy, legacy products, and biotechnology are integrated
Provide input into the future development of PQLI

Technical Documents - www.ISPE.org/publications
Preliminary PQLI-related technical documents have been published in the Journal of Pharmaceutical Innovation; watch for more publications in the future.

Who Should Attend

This will be of interest to a range of participants from senior leaders to project managers from regulatory, development, quality, and manufacturing who wish to facilitate the future framing of QbD

ISPE Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API), Commissioning and Qualification (C&Q), Process Analytical Technology (PAT), Project Management (PM), and Process/Product Development (PPD)

Program elements and speakers subject to change.

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Session Speakers

John Berridge, Pharma Quality & Reg., , United Kingdom
Joseph Famulare, Senior Director, External Influence & Compliance, Genentech Inc, USA
Yukio Hiyama, Section Chief, Drugs Div, National Institute of Health Sciences, Japan
Frank Holcombe, Associate Director for Chemistry, Office of Generic Drugs, OPS, FDA, USA
Gert Moelgaard, Vice President, Consulting, NNE Pharmaplan, Denmark
Jacques Morenas, Assistant Director, AFSSAPS, France
Moheb Nasr, Dir, Office of New Drug Quality, FDA/CDER/ONDQA, USA
Christopher Potter, , CMC Pharmaceutical Consultant, United Kingdom
Jean-Louis Robert, Head of Department, National Health Laboratory, Luxembourg
David Selby, Managing Director, Selby Hope International Ltd, United Kingdom
James Spavins, Vice President, Global CMC, Pfizer Inc, USA