VIV Podcast

One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and Risk-Based Approach to Post-Approval Changes – Part 2

On Part 1 of this series we introduced the concept of One-Voice-of-Quality to our listeners and had a chance to really lay out the ramifications of failure to change, not only in the Post Approval Change process, but the mindset around the implementation of a global regulatory framework. In this follow-up episode - Part 2, you will hear from Emma Ramnarine once again as we provide details for a greater understanding around the how’s and who’s that are necessary to this One-Voice-of-Quality vision. 

Read more from Emma on this topic:

  1. 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
  2. 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
  3. Continual Improvement While Maintaining A State of Control: A Concealed Paradox or a Mutual Interdependence?
  4. Demonstrating Pharmaceutical Quality System Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.
  5. PDA PAC iAM 2017 Survey on Post-Approval Change: Is the Regulatory Environment Hindering Much-Needed Innovation in the Pharma Industry
  6. PDA Technical Report 68: Risk-Based Approach for Prevention and Management of Drug Shortages

Join the discussion at:


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