Shared Responsibility Model and Use Cases for Decentralized Technology in Life Sciences

Presented By: Dori Gonzalez-Acevedo, Co-Founder and CEO, ProcellaRX & Tanya Sharma, Co-Founder, Assurea Forward-thinking organizations are finding new and innovative ways to utilize blockchain and decentralized ledgers in their business processes, but for many this is still uncharted territory and brings with it many uncertainties. This is certainly true in the life sciences industries where […]

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Developing a Laboratory Disaster Plan

Created by: Christopher V. Latoz, Stability Manager, Hollister Incorporated Many laboratories have not taken the time to develop a disaster plan, or the plan they have created has not been reviewed or revised for several years. In this article, we’ll discuss key elements that should be incorporated in a laboratory disaster plan, including a hazard […]

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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: ADDRESSING UNCERTAINTY

Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University Dublin 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 […]

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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: DETERMINING THE LEVEL OF FORMALITY

Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University Dublin 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 […]

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IMPROVING RISK BASED DECISION MAKING EFFECTIVENESS: A CASE FOR RISK DECISION REVIEW POINTS (KDRPS) IN THE QUALITY RISK MANAGEMENT PROCESS

Authors: Valerie Mulholland, Pharmaceutical Regulatory Science Team (PRST), Technological University DublinProfessor Anne Greene, Director PRST, Technological University Dublin 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 […]

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