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.
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 3
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 2
Advancing Precision Oncology: Expanding Patient Access to Biomarkers and Testing Capabilities Part 1
CAR-T boxed warnings: What comes next?
Preparing for a Cell and Gene Future | Episode 1: Looking Back at 2023 Achievements
Three trends impacting market access in the EU
How can we advance fair and ethical reimbursement for patients?
Beyond the Binary: Navigating Gender Diversity in Clinical Research
Why Rare Disease Therapeutics Need Early Market Access Planning
CROs and Their Role for Nano-rare
RBQM Podcast Series | Episode 4: Three ways to de-risk your DCT implementation
Careers at Parexel — FSP Podcast Series | Episode 2: Celebrating a 25-Year Career with Kerri McCaul-Claus
Careers at Parexel — FSP Podcast Series | Episode 1: Get Recruited to Be a Clinical Research Associate: The Benefits of Parexel’s FSP Program
The Parexel Podcast | Episode 20: Driving change in Cell & Gene Therapies: Key learnings from the SITC Virtual Summit
Decentrally Speaking | Episode 3: Integrating the Patient Voice into Decentralized Trials
Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment
RBQM Podcast Series | Episode 2: Cultivating Risk-based Behaviors
Decentrally Speaking, a Parexel Podcast | Episode 1: Optimizing Trial Inclusivity For Patients From Under-Represented Communities
Episode 19: Improving Rare Disease Drug Development
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