Post-approval changes are part of the drug development lifecycle, as drug makers gain new knowledge, and work toward continuous improvement, but as we have seen during this pandemic managing high volume of PACs in a short timeframe has been a considerable challenge. This global problem requires a global solution, and our guest today has a solution, which she will share in this discussion. Emma will share her idea developed as a "One Voice of Quality" concept which essentially requires the pharmaceutical industry to work together to demonstrate that product and process knowledge and systems are strong enough to allow for independent post-approval changes.
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