Guest User
FDA releases Final Guidance for BIMO Inspection ...

03/23/2026

-

On December 19th, 2025, the US Food and Drug Administration released the finalized guidance for industry: Processes and Practices Applicable to Bioresearch Monitoring Inspections. The guidance details the processes and practices of Bioresearch Monitoring Program (BIMO) inspections of FDA-regulated establishments NOT specified in existing FDA guides or manuals.

FDA releases Final Guidance for BIMO Inspection Program Processes and Practices Not Found in Current Industry Guides or Manuals
Guest User
FDA Releases Final Guidance on ICH E6(R3)

02/03/2026

-

On September 8th, 2025, the US Food and Drug Administration (FDA) released their final guidance for industry on the ICH E6(R3) Good Clinical Practice (GCP). ICH E6(R3) Principles and Annex 1 were finalized on January 6th, 2025, officially taking over the preceding 2016 ICH E6(R2). Annex 2 is expected to be finalized in early 2026.

FDA Releases Final Guidance on ICH E6(R3)
Guest User
Finalized Guidance for Industry: Investigator ...

01/08/2026

-

On December 15th, 2025, the US Food and Drug Administration (FDA) released the finalized guidance for industry “Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices”. Unlike most updates, this finalized guidance is replacing the FDA’s recommendations from two separate final guidance documents: “Safety Reporting Requirements for INDs and BA/BE Studies” from 2012 and “Adverse Event Reporting to IRBs—Improving Human Subject Protection” from 2009, both of which are now withdrawn.

Finalized Guidance for Industry: Investigator Responsibilities for Safety Reporting
Guest User
EU Commission Releases Draft Annex 11: ...

12/02/2025

-

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
Guest User
Warning Letter Issued to Investigator of ...

11/18/2025

-

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

Electronic Informed Consent (eIC): "How The New FDA/OHRP Final Guidance Affects You" - Attend the Feb 22nd WEB Session

2/8/2017

Date: February 22, 2017

Time: 1pm - 2:30pm EST

Duration: 90 Minutes - Online

Sponsored by Life Science Training Institute

To Sign-up: https://www.lifesciencetraininginstitute.com/doc/electronic-informed-consent-eic-fda-ohrp-final-guidance-training-0001

Description:

An Electronic Informed Consent (eIC) solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies. The newly FDA and OHRP guidance “Use of Electronic Informed Consent – Questions and Answers” reflects the current regulatory thinking on eIC particularly since it is seen as a partner to the paper process instead having to be an either or proposition.

“GCP Renovation” for the Modernization of ICH E8 and Subsequent Renovation of ICH E6! Series Part 1/4

2/6/2017

The International Council for Harmonisation (ICH) is inviting public review and comment on a recently released reflection paper on ICH E6 and ICH E8 renovation and modernization available here. ICH seeks to develop clear guidelines that are “both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources that are being employed to support regulatory and other health policy decisions” while continuing to ensure the human protection and high quality data principles.

Update to ICH GCP E6 (R2) – Final Changes and Implementation – Attend the Feb 15th WEB Session

2/1/2017

The ICH GCP draft is has now been updated and finalized by ICH. Let’s discuss the final content and major implications, how to determine next steps. The update helps end the debate related to many best practices. This impacts sites a great deal and the oversight by sponsor/CROs. Then what about the IRB/IEC?  We will be having a variety of sessions for discussion, training and action planning. To access the guidance, visit the ICH website: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Step_4.pdf