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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?

Reducing Regulatory Risk with eConsent Part 5/5

1/23/2017

Link: http://resources.crfhealth.com/h/i/294228828-reducing-regulatory-risk-with-econsent/279183

Informed Consent is a cornerstone of research upon which we ensure human subject protection and data integrity; for many years the use of a paper based process has been the industry default. Electronic Informed Consent (eIC) seeks to revolutionize the process due to its ability to improve consent compliance, validate participant comprehension and provide an accurate audit trail of the development, use and amendments.

Remote Monitoring Implementation Post ICH GCP E6 (R2): A Practical Guide - Attend the Jan 18th WEB Session

1/17/2017

Date: January 18, 2017

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: http://www.lifesciencetraininginstitute.com/doc/remote-monitoring-implementation-post-ich-gcp-training-course-0001

Description:

According to the ICH E6 (R2) Step 4 version from November 9th 2016 “In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the E6(R2) addendum text should take priority” this means that now is more important than ever to understand and evaluate how the new updates affect the way research is conducted.

How eConsent Improves Consent Development Part 4/5

1/16/2017

Link: http://resources.crfhealth.com/h/i/289589724-how-econsent-improves-consent-development/279183

Developing informed content requires a lot of back and forth communication between multiple stakeholders. The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses many of the challenges facing researchers by proposing the use of eConsent as a solution. This guidance clarifies the role of the IRB, sponsor and investigator to ensure a successful electronic informed consent process.