Project Scope |
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Develop The scope of this project is to develop a BIMO Frequently askedAsked Questions Forum to be posted on the PHUSE Advance Hub, following the same format as the SEND FAQ forumForum. This forum will utilizeuse questions brought forward by the pharma/CRO community via public review, presentations, PHUSE BIMO team members, etc..and so on. |
Problem Statement |
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The FDA drafted the initial Bioresearch Monitoring Technical Conformance Guide in December 2017, with an updated version published in July 2020. Reference: Bioresearch Monitoring Technical Conformance Guide - Guide https://www.fda.gov/media/85061/download The . The guide provides specifications for preparing and submitting the following components in electronic format that are used by the FDA for the planning of Bioresearch Monitoring bioresearch monitoring (BIMO) inspections.:
The NDA, BLA , and supplemental submissions to the FDA require BIMO as a critical part of the electronic application. Pharma companies and CROs have individually developed BIMO standards based on the recent guidance from the FDA. A coordinated approach to responses to Frequently frequently asked BIMO questions can benefit sponsors as well as the FDA. |
Problem Impact |
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A coordinated approach to BIMO Frequently Asked Questions can benefit sponsors as well as FDA. It was apparent during the creation of the PHUSE Bioresearch Monitoring Data Reviewer'sReviewer’s Guide (BDRG) that organisations implementing BIMO Submissionsubmission packages have outstanding questions. The BDRG team captured a lot of those questions in our Communication Tracker (repository of questions and team responses). While most questions were directed at the BDRG effort, there were many general questions that came up during review, presentations ,etc... |
Project Leads | |
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Julie Maynard (Johnson & Johnson) | jmaynar1@its.jnj.com |
Sopan Kaith (Cytel) | sopan.kaith@cytel.com |
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
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Project approved Q3 2022.
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Project Members | Organisation |
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Bidhya Basnet | Gene |
Chunying Yin | Johnson & Johnson |
Dyuthi Yellamraju | Genentech |
Jack Field | AstraZeneca |
Jean Mulinde | FDA |
Kanaeko Ravenell | CBER/FDA |
Kantish Chowdhury | IQVIA |
Kirsty Wall | GSK |
Linping Li | Merck |
Lisa Zhou | Johnson & Johnson |
Madhavi Kommalapati | IQVIA |
Mathura Ramanathan | IQVIA |
Meng Li | AstraZeneca |
Phyllis O’Hara Smetana | UCB |
Rashed Hasan | FDA |
Kanaeko Ravenell | FDA |
Sai Ma | Bayer |
Santosh Lingala | Gilead |
Saritha Bathi | Bristol Myers Squibb |
Srinivasan Ramasubramanian | Abbvie |
Triet Tran | FDA/CBER |