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EU Commission Releases Draft Annex 11: ...

12/02/2025

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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.

EU Commission Releases Draft Annex 11: Computerised Systems
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Warning Letter Issued to Investigator of ...

11/18/2025

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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.

Warning Letter Issued to Investigator of Pediatric Study
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ISO Release DIS 9001:2026 for Quality ...

11/06/2025

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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.

ISO Release DIS 9001:2026 for Quality Management Systems
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Problems Found in Sponsor-Investigator Led Trial

10/30/2025

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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.

Problems Found in Sponsor-Investigator Led Trial
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Sponsor BIMO Warning Letter – What is a Drug?

10/08/2025

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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.

Sponsor BIMO Warning Letter – What is a Drug?

Brexit impact on Current and Future Trials in the European Union

5/4/2017

Since March 29th 2017 when the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), the clinical research industry has been wondering about the implications of this unprecedented withdrawal particularly since the European Commission and EMA believe that the UK will no longer participate in the EMA’s work after March 30th of 2019.

Pediatric Clinical Trials: Special Considerations and Requirements - Attend the May 15th WEB Session”

5/2/2017

Date: May 15, 2017

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: https://www.lifesciencetraininginstitute.com/doc/pediatric-clinical-trials-special-considerations-and-requirements-0001

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.

2017 Edition of International Compilation of Human Research Standards Now Available

3/13/2017

“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.