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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.
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On January 31st, 2025, the European Medicines Agency (EMA) reached another major milestone for the implementation of the Clinical Trials Regulation (CTR), the European Union’s (EU) current pharmaceutical legislation. The CTR has updated the many of the CTD policies; promoting communication between trials and regulators, increased transparency between trials and the public, and reducing financial and administrative burdens.
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On April 4th, 2025, the U.S. Food and Drug Administration (FDA) updated their Institutional Review Board (IRB) Guidance Manual, part of the Bioresearch Monitoring (BIMO) Compliance Program. Staying up to date with these sorts of regulatory updates will help better prepare for inspections and give IRBs a chance to update any relevant protocols or policies that may not be compliant with these new changes.
Date: June 16, 2016
Time: 1:00pm-2:30pm, EDT US
Duration: 90 Minutes - Online
Course Link: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001
UPDATE: This course will include discussion of the NEW FDA Draft Guidance “Use of Electronic Health Record (EHR) data in Clinical Investigations”
June 14th, 2016, TOMORROW
11:00 am EDT | 16:00 GMT
Key processes within our industry have been in need of substantial change and improvement, one being the informed consent process.
Informed consent is still one of the most cited regulatory deficiencies, this along with the new technologies available will make electronic consent more and more commonplace. Facing this new reality, we must learn how this impacts each stakeholder.
An FDA warning letter issued by Director David Burrow, Pharm.D., J.D. of the U.S. Food and Drug Administration to Benedict S. Liao, M.D. informs Dr. Benedict of the “objectionable conditions observed during” the course of an FDA inspection conducted at his clinical site between August 11 and September 29, 2015. This letter is a great example of the importance of having proper investigator training on research and the study protocol. Many of the findings outlined in the Form FDA 483 can be traced back to the investigator’s brazen disregard for the protocol and lack of understanding of the difference between standard of care and clinical research, as seen in his written response:
