RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry
By designing quality into trials, we focus on the most critical data and create a framework for efficiently identifying and addressing any risks to patients, the integrity of data, or regulatory compliance. While part of regulatory guidance, consistent interpretation of RBQM approaches by regulatory inspectors is an area of concern. In such a highly regulated industry that is notably slow to adopt change, biopharmaceutical companies and CROs are still debating how to go with evidence-backed documentation to satisfy regulatory requirements when using risk-based approaches.
In the third episode of our RBQM podcast series, Amy Kissam-Sands, Senior Vice President of Clinical Operations and Dr. Kristin Murphy, Senior Director and Global Head of the Change and Adoption Center of Excellence, discuss how to work within the regulatory guardrails when establishing a risk assessment framework.
Related Insights
Blog
Leveraging the draft FDA Guidance on PBPK for your drug development program
Feb 24, 2021
Blog
AI Milestones: FDA’s ISTAND program accepts AI-based assessment tool for depression
Mar 19, 2024
Blog
Summary and assessment: Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products: Discussion Paper and Request for Feedback (FDA)
Mar 7, 2024
Blog
Summary and assessment of EMA’s reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle
Mar 7, 2024
Blog
Regulatory acceptability of AI: Current perspectives
Mar 7, 2024
Playbook
Are you using real-world evidence?
Feb 1, 2023
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Whitepaper
Optimizing Biosensor-based Trials
Feb 1, 2023
Webinar
How to navigate China’s regulatory environment
Feb 15, 2023
Related Insights
Blog
Leveraging the draft FDA Guidance on PBPK for your drug development program
Feb 24, 2021
Blog
AI Milestones: FDA’s ISTAND program accepts AI-based assessment tool for depression
Mar 19, 2024
Blog
Summary and assessment: Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products: Discussion Paper and Request for Feedback (FDA)
Mar 7, 2024
Blog
Summary and assessment of EMA’s reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle
Mar 7, 2024
Blog
Regulatory acceptability of AI: Current perspectives
Mar 7, 2024
Playbook
Are you using real-world evidence?
Feb 1, 2023
Blog
FDA’s new priority voucher review program: Potential implications and next steps for sponsors
Jun 20, 2025
Whitepaper
The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations
Mar 9, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Playbook
Mitigating risk, protecting potential: Practical strategies that position cell and gene therapy development for success
Mar 28, 2023
Whitepaper
Optimizing Biosensor-based Trials
Feb 1, 2023
Webinar
How to navigate China’s regulatory environment
Feb 15, 2023