Publications by authors named "Emma Ramnarine"

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Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability.
Anders Vinther, Emma Ramnarine, Thierry Gastineau, Laura O'Brien, Oliver Brehm

Ther Innov Regul Sci· May 2024

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Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide.
Anders Vinther, Fanzia Mohammed, Emma Ramnarine

PDA J Pharm Sci Technol· November 2021

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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.
Emma Ramnarine, Anders Vinther, Kimberly Bruhin, Christina Tovar, Marcello Colao

PDA J Pharm Sci Technol· June 2021

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Managing Excipient Supplier Name and Address Changes in the Pharmaceutical Quality System.
Richard Rolke, Emma Ramnarine, Anders Vinther, Anil Sawant

PDA J Pharm Sci Technol· January 2021

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Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management.
Anders Vinther, Emma Ramnarine

PDA J Pharm Sci Technol· June 2020

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Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Risk Reduction.
Emma Ramnarine, Kevin O'Donnell

PDA J Pharm Sci Technol· March 2019

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PDA PAC iAM 2017 Survey on Post Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry?

PDA J Pharm Sci Technol· February 2019

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PDA Points to Consider: Technical Product Lifecycle Management. Pharmaceutical Quality System Effectiveness for Managing Post-approval Changes.

PDA J Pharm Sci Technol· January 2019

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PDA Points To Consider: Technical Product Lifecycle Management: Communication and Knowledge Exchange between Marketing Authorization Holders and Health Authorities.

PDA J Pharm Sci Technol· December 2018

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2015/2016 Quality Risk Management Benchmarking Survey.
Kelly Waldron, Emma Ramnarine, Jeffrey Hartman

PDA J Pharm Sci Technol· June 2018

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