Risk Revolution #4

This week our series coordinators, Lori and Nuala, will engage their guest Valerie Mulholland in a lively discussion on a critical aspect of Risk Management, namely the skills and confidence necessary to making effective and timely risk-based decisions.

Articles:

1. Quality Risk Management: Seeking the Diamonds: Making the Case for Improved Formality in QRM Decision-making https://arrow.tudublin.ie/level3/

2. Role of Senior Leadership in Quality Risk Management | IVT - Risk - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-management

3. Understanding the Concept of Formality In Quality Risk Management http://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management-0

Other Resources:

1. ISO 31010 – Risk Management - https://www.iso.org/iso-31000-risk-management.html

2. ICH Q9. Risk Based Decisions We first encounter it in the Introduction to the guideline: “Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.” And specifically, “…some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.”

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