For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
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.
Are you using real-world evidence?
Feb 1, 2023
Leveraging the draft FDA Guidance on PBPK for your drug development program
Feb 24, 2021
EU-CTR: Preparing for trial transition
Nov 30, 2023
Overcoming asset transfer challenges during a merger and acquisition (M&A)
Oct 20, 2021
Clinical pharmacology, modeling and simulation to support FIH study design
Oct 21, 2021
Part 2: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Biosimilar Development: Are therapeutic clinical trials needed?
Nov 16, 2021
Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial
Nov 19, 2021
Creating EU-CTR compliant and patient-friendly lay language summaries (LLS)
Jan 26, 2022
CNS Summit Recap: The Future is Collaborative
Nov 22, 2021
Actigraphy advances a patient-first approach: Reduce patient burden — and make the most of valuable data
Oct 15, 2021