Paper 4: Improving Risk Based Decision Making Effectiveness: Addressing Uncertainty

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Improving Risk-Based Decision Effectiveness:
Addressing Uncertainty

ABSTRACT

The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued to progress research on quality risk management (QRM), knowledge management (KM) operational excellence (OpEx), post-approval change management (PAC, and PAC 1VQ), quality metrics and related topics covered by ICH Quality Guidelines.

Recently the focus of the PRST has been on Risk-Based Decision Making (RBDM) and as such has written series of 4 papers on strategies to improve RBDM effectiveness. This is the final paper in the series and it explores strategies to improv risk based decision making effectiveness under uncertainty.

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Valerie Mulholland

Principal Consultant, GMP Services Researcher PRST TU Dublin

Valerie Mulholland is the Senior Consultant with GMP Services based in Ireland.
For over 20 years she has provided Regulatory and Compliance Intelligence, including training & auditing services to the biopharmaceutical, pharmaceutical, medical device and blood transfusion industries.
She is a researcher with the Pharmaceutical Regulatory Science Team (PRST) in TU Dublin.
Valerie’s own area of interest is decision making within QRM and the PQS, and she provides training and consultancy on risk-based decision-making.
She is the current secretary of the Irish Chapter of the PDA, engaging with regulators and industry experts on topical areas of interest across the biomanufacturing industry.
She is a co-host of the Risk Revolution Podcast.

Anne Greene,

Professor & Head of Part-Time Education School of Chemical & Biopharmaceutical Sciences, TU Dublin

Professor Anne Greene heads the Pharmaceutical Regulatory Science Team (PRST) in Technological University  Dublin, where she is a senior lecturer and has spearheaded the development of several MSc and BSc Pharmaceutical Programmes. She has supervised industry based executive students to PhD awards in areas of Quality Risk Management, Knowledge Management, Operational Excellence, and PQS. She is currently Head of Part-time Education in the School of Chemical and Biopharmaceutical Sciences in TU Dublin.

Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector in Validation and Technical Management roles. Anne has a BSc and PhD in Chemistry from University College Dublin.

Anne was a founding member of the PDA Ireland Chapter, where she has held several Officer positions, and is currently a member of the PDA Ireland committee.

Martin J. Lipa, PhD
KM Consultant Lipa Group LLC, PRST, Research Fellow, TU Dublin

Martin (Marty) Lipa has over 25 years of biopharmaceutical industry experience, including over a decade in Knowledge Management (KM), and is a US Department of State Fulbright Specialist Award recipient.
Marty is currently Senior Research Fellow with the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin and an independent KM consultant. Marty was formerly Executive Director at Merck & Co. where he founded Merck’s KM program and delivered significant value enhancing operational efficiency, quality and talent development. Marty is a Lean Six Sigma Black Belt, a certified process manager, skilled in transformational change management, with prior experience including roles in technology, engineering, operations, digital, and validation.
Marty is an active member of the global KM community as a regular speaker, author, and volunteer, and has been recognized for his industry contributions, including by the US Fulbright Commission, ISPE as Member of the Year, and Manufacturing Leadership Council for workplace innovation.
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