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, John Bell, Chief Quality Officer, 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
Summary and assessment of EMA’s reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle
Mar 7, 2024
Blog
Leveraging the draft FDA Guidance on PBPK for your drug development program
Feb 24, 2021
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
AI Milestones: FDA’s ISTAND program accepts AI-based assessment tool for depression
Mar 19, 2024
Playbook
Are you using real-world evidence?
Feb 1, 2023
Blog
Regulatory acceptability of AI: Current perspectives
Mar 7, 2024
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Article
New endpoints for early-stage cancer are gaining regulatory traction
Jan 28, 2022
Article
How biotechs can strengthen their value story with advanced analytics
Feb 15, 2022
Video
On-demand webinar: An expert guide to EU-CTR
Mar 10, 2022
Article
New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle
May 10, 2022
Blog
Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions
May 16, 2022
Related Insights
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
Leveraging the draft FDA Guidance on PBPK for your drug development program
Feb 24, 2021
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
AI Milestones: FDA’s ISTAND program accepts AI-based assessment tool for depression
Mar 19, 2024
Playbook
Are you using real-world evidence?
Feb 1, 2023
Blog
Regulatory acceptability of AI: Current perspectives
Mar 7, 2024
Video
Cell & Gene Therapies: A Regulatory Update
Jul 22, 2022
Article
New endpoints for early-stage cancer are gaining regulatory traction
Jan 28, 2022
Article
How biotechs can strengthen their value story with advanced analytics
Feb 15, 2022
Video
On-demand webinar: An expert guide to EU-CTR
Mar 10, 2022
Article
New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle
May 10, 2022
Blog
Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions
May 16, 2022