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Home > Voices In Validation > 1VQ Solutions: Enhanced Science and Risk-Based Approach to Post-Approval Changes - Part 1


	Podcast:		Voices In Validation
	Episode:		1VQ Solutions: Enhanced Science and Risk-Based Approach to Post-Approval Changes - Part 1
	Category:		Science & Medicine
	Duration:		00:45:11
	Publish Date:		2020-10-13 04:01:00
	Description:		On this episode, Stacey is joined by Emma Ramnarine, Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. Stacey and Emma discuss managing high volume of PACs in a short timeframe and how to solve this problem. Emma is Co-lead for the Industry One-Voice-of-Quality (1VQ) Initiative on Post Approval Changes. This initiative is sponsored by Chief Quality Officers of 20+ global pharma companies who have decided to speak with a unified voice, and develop standard solutions to reduce global PAC complexity. Emma has 20+ years of global experience in the pharmaceutical, biotechnology and medical device industries in Analytical Science & Technology, Risk Management, Quality Control and Quality Management Systems. She is currently on the PDA Board of Directors and has led several PDA Task Forces and Technical Reports (TR) including a series of TRs on “Implementation of Quality Risk Management” and “Risk Based Approach for Prevention and Management of Drug Shortages”. Emma is currently Global Head of External Development Collaborations at Genentech/Roche, managing the external network for development, manufacturing, and clinical collaborations of Roche’s Biologics and Small Molecules development portfolio. Prior to this, she was the Global Head of Analytical Science and Technology at Genentech/Roche, providing strategic direction and leadership for product control systems lifecycle management, analytical technology innovation and tech transfers. She is also a worldwide-recognized expert on Quality Risk Management (QRM), and continues to provide QRM training to regulatory authorities and at industry forums. Emma holds an M.S. in Pharmaceutical Sciences from the University of Connecticut, an M.S. in Medicinal & Pharmaceutical Chemistry, and a B.S. in Pharmacy, both from University of Indore, India. She is currently pursuing her PhD in Pharmaceutical Sciences from Technological University Dublin; her research focuses on this topic of transforming PAC management to solve the continual improvement and innovation challenge in the pharmaceutical industry. Read more from Emma on this topic: Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches Industry One-Voice-of Quality Concept Paper: Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transforms Post-Approval Change Management Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence? Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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