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On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.
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In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.
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On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency.
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On March 25, 2025 the U.S. Food and Drug Administration (FDA) issued a warning letter to the sponsor-investigator of a study due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection. The sponsor-investigator’s written response to the FDA Form 483 were deemed inadequate therefore the FDA issued a warning letter stating that the sponsor-investigator was noncompliant with multiple regulations within 21 CFR part 312.
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On April 30th, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter and Form FDA 483 to the sponsor of a clinical investigation as the result of a Bioresearch Monitoring Program (BIMO) inspection. 40 participants were enrolled in the study and took the investigational product that the sponsor claims was to help individuals with sleeping disorders without submitting an Investigational New Drug (IND) application.
Date: May 15, 2017
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
Description:
Pediatric clinical trials present unique challenges since minors, as a vulnerable population, require a variety of regulatory protections to be incorporated as part of the study’s design, recruitment strategies, and monitoring plan.
Date: April 20, 2017
Time: 11:00 am EST | 15:00 GMT
Join us and CRF Health on this upcoming webinar hosted by Xtalks. We'll discuss the following benchmarks from the State of eConsent 2017 Report: https://attendee.gotowebinar.com/register/5600985180645861634
“Q: If local policy differs from the region’s regulations pertaining to the conduct of a clinical trial at a research site, what should be followed? A: The strictest requirements”. In response to this question one may ask, where can I find the local regulations for my study? A situation compounded in multinational trials. A helpful tool to reference is the OHRP’s International Compilation of Human Research Standards which was first published on 2005.
Time: 12-1 pm
To Sign-up: Link to ACRP eConsent Webinar
Registration Deadline: February 27, 2017
Description:
In this webinar Sandra “SAM” Sather, VP, Clinical Pathways, Regulatory & Quality lead for eConsent, CRF Health Trial Consent and Michael Conde, is the Senior Director of Technical Solutions at CRF Health discuss how eConsent (eIC) improves investigator, sponsor and IRB oversight for informed consent and decreases risks.
