Fda
The Evolution of Clinical Quality: Key Considerations from ICH E6 R3
Explore the key updates in ICH E6 R3 and their impact on clinical quality
Good Manufacturing Practices: When Do They Apply?
Ensure product quality and compliance in the drug development process. Learn how to optimize your manufacturing processes and maintain key regulatory standards with cGMP best practices from experts.
The Regulatory Binder Checklist For Clinical Trial Sites
This checklist offers a comprehensive framework for managing all necessary essential regulatory documents efficiently.
Ace Your Next FDA Inspection
Discover valuable insights and expert guidance on navigating FDA inspections in clinical research.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
Takeaways From the FDA’s VRBPAC Meeting – October 22, 2020
On October 22, 2020, the FDA's VRBPAC met to discuss the development, authorization, and licensure of vaccines to prevent COVID-19.
Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements
Find out more about what to report to whom--and when--in the Q&A blog follow-up to our recent webinar. Read the answers to popular audience questions:
Making a Case for Interim HRPP Staffing
Don't wait to fill an HRPP position until it's too late. Understand the risks of an understaffed HRPP and how interim staffing support can help. Read more:
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