Regulatory & Quality Track

Clinical research leaders and teams will gain critical insights and proven best practices to uphold compliance, elevate quality, and ensure excellence in trial execution.

 
Featured
Building an Integrated Clinical Evidence Strategy for Medical Device R&D
How the New Single IRB Requirements Will Change Clinical Research
Compensating Research Subjects: The Fine Line Between Fairness and Inducement
The Clinical Research Technology Reboot: Are We Getting it Right?
European Data Privacy Roadmap: Balancing Research, Innovation, and Compliance
ICH E6(R3): Real-World Questions & Answers
Comparing and Contrasting Approaches to In Vitro Diagnostics Research vs. Other Medical Devices
Your Guide to 21 CFR Part 11 and Annex 11 Compliance
Inspection Readiness: It's All About the Data
FDA's Latest Guidance on Informed Consent: Reading Between the Lines
Principles to Practice: An Understanding of the ICH E6(R3) Update’s Effect on Good Clinical Practice
CANCELED—FEAR: Face Everything and Rise (in Clinical Research)
Ethical Dilemmas in Genetic Information for Clinical Research
Demystifying Institutional Review Board Structures and Processes
A Regulatory Framework for Testing Artificial Intelligence as a Medical Device
FDA Inspection Readiness: Is Your eSource Fit for Purpose?
2025 U.S. Regulatory Update
The Limits of "De-identification" in Clinical Research Data