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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: January 18, 2017
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
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.
We are proud to announce that 6 of our Good Clinical Practice (GCP) Trainings for Investigative Sites courses are now listed on the TransCelerate website: http://www.transceleratebiopharmainc.com/gcp-training-attestation/list-of-training-providers/.
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.
Link: http://resources.crfhealth.com/h/i/287066229-recruiting-and-retaining-patients-with-econsent/279183
The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses ways in which eConsent can facilitate the subject’s comprehension of the information presented during the consent process, such as explaining scientific and medical terms and the risks associated with participation.
3 Ways Electronic Informed Consent Benefits Trial Participants
There are some exciting things happening in clinical research; one of which is patient centric focused trials and improvements in informed consent. Electronic Informed Consent (eConsent) is here to help. One of the goals of eConsent is to support a subject become a successful participant leading to better patients and better data.
