Part 2: Risk-based Quality Management Video (RBQM) Series
While patient safety remains the primary concern of guidance ICH E6, revision 3 further directs sponsors to include patients in the research process. In part two of our RBQM video series, Amy Kissam-Sands and Tim Audin, Senior Director, Global Biometrics Group Lead talk with Taren Grom, Editor, PharmaVOICE about how to implement a proactive risk-management approach and address patient input in study design.
Related Insights
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Article
Decentralized trial tools and technologies are here to stay: A regulatory perspective
Jul 23, 2021
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Report
New Medicines, Novel Insights: Achieving patient-guided drug development
Oct 30, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Video
The FDAs Race and Ethnic Diversity Plan Guidance: How prepared is your organization?
Feb 1, 2023
Blog
Including patients in DCT design
Sep 13, 2022
Blog
Adapting the validation process for PROs for rare diseases and other diseases with large unmet need and/or rapid progression
Apr 23, 2024
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Video
The 2024 FDA Diversity Guidance Update: What does it mean for patients, sites, sponsors and CROs
Aug 22, 2024
Related Insights
Report
New Medicines, Novel Insights: Accelerating development of cell and gene therapies
May 22, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Article
Decentralized trial tools and technologies are here to stay: A regulatory perspective
Jul 23, 2021
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Report
New Medicines, Novel Insights: Achieving patient-guided drug development
Oct 30, 2023
Video
How to transition existing trials under EU-CTR
Feb 1, 2023
Video
The FDAs Race and Ethnic Diversity Plan Guidance: How prepared is your organization?
Feb 1, 2023
Blog
Including patients in DCT design
Sep 13, 2022
Blog
Adapting the validation process for PROs for rare diseases and other diseases with large unmet need and/or rapid progression
Apr 23, 2024
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Video
The 2024 FDA Diversity Guidance Update: What does it mean for patients, sites, sponsors and CROs
Aug 22, 2024