Navigating Supply Chain Risk

Episode 18,  Nov 02, 06:38 PM

Welcome to Risk Revolution, a monthly series of Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. 

In this episode, your hosts Nuala Calnan and Valerie Mulholland are joined by Ann McGee of MIAS Pharma and Chris Flask from Roche to reflect on what we have learned about supply chain fragility, security, and risks in our new ‘post-pandemic’ world.

About our guests:
Chris Flask, Global Business Capability Owner, Roche Warehousing
With over 20 years in Pharma, Chris has held a variety of roles in Manufacturing, Strategic Development, and Supply Chain. All of these roles have required the development of Business Continuity Plans to ensure the continued supply of critical medicines to patients across the globe. Prior to his current role, Chris led the North American hub warehouse for Roche Drug Substance, managing the flow of $40 billion dollars worth of products annually.

Ann McGee, Chief Innovation Officer, MIAS Pharma Limited
MIAS Pharma Ltd is the brainchild of Ann McGee, a former Senior Inspector with the Irish Competent Authority (HPRA). MIAS Pharma Ltd was founded to build on Ann’s vision of accelerating and innovating compliant patient care. With the exceptional growth of the biopharmaceutical sector across the globe, MIAS Pharma acts as a catalyst to make Europe an accessible market for new medicines in the most time-efficient and cost-effective manner.

Resources from this episode:
Revised ICH Q9 (R1) - https://www.fda.gov/media/159218/download
FDA RMP draft guide - https://www.fda.gov/media/158487/download

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