-
In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.
-
In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.”
-
In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.
-
In January 2025, the US Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products” for trial sponsors and stakeholders intending to use AI to generate data and clinical evidence.
-
In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.
-
Dates: Two part series – Online live attendance mandatory
19 Oct 2021, 10:00 AM 1:00 PM (EDT)
AND
26 Oct 2021, 10:00 AM 1:00 PM (EDT)
Location: Live online
Registration: HERE
DIGR-ACT® is a process for you to integrate into your operations to better support critical to quality factors and your quality system in a rapidly changing environment. Better handling and prevention of issues that matter means better project outcomes and less tears!
-
Date: September 16th OR 23rd, 2021. Choose which date works for you.
Time: 10:30 AM - 12:00 PM EDT
Location: Interactive Webinar
Registration: September 16 Registration HERE September 23 Registration HERE
Cost: AGXPE Member – $79.00
Non-Member Registration – $89.00
Clinical Pathways is pleased to announce a partnership with the Association for GXP Excellence (AGXPE). AGXPE will present the 90-minute interactive webinar hosted by Sam Sather and Keith Dorricott, founders of DIGR-ACT®.
This session will address the challenges in using root cause analysis to lead to effective risk assessment and CAPA for GXP. It will also introduce the challenges and gaps from a process approach standpoint related to integration of essential human performance factors and critical thinking process support. They include highlights of the current significant challenges to performing risk assessment and CAPA without a modern approach to root cause analysis.
These sessions introduce to the GXP audience to DIGR-ACT® as a solution to mature teams and processes in the era of big change.
-
SAM Sather and Keith Dorricott co-authored an article published in Clinical Leader entitled, “Clinical Trial Root Cause Analysis: Can't We Do Better Than Five Whys?” If you have experience with Good Clinical Practice (GCP), you may know that ICH E6(R2) now requires sponsors to conduct a root cause analysis (RCA) and implement appropriate corrective and preventive actions (CAPA) for noncompliance “that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results.”
