Articles by Kevin O'Donnell - Pharmaceutical Technology

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Articles by Kevin O'Donnell

Kevin O'Donnell


Kevin O'Donnell, PhD, is Market Compliance Manager of the Irish Medicines Board (IMB).

A New Risk-based GMP Inspection Planning Tool
November 2, 2012

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has finalized a risk-based inspection planning tool for inspectorates to use in applying science- and risk-based principles to planning GMP inspections.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Reducing drug shortages
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Protecting the supply chain
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Expedited reviews of drug submissions
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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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