Project Scope Develop a Data Reviewer’s Guide Template (referenced in the Technical Conformance Guide) and associated documents to allow up front communications regarding the sponsors interpretation of the Bio-research Monitoring Technical Conformance Guide. Initially, the scope will include the development of the template and then expand to cover the full suite of documents. The current cSDRG and ADRG templates will be considered to avoid unnecessary duplication of content. Therefore, revision of these templates are not in scope. |
Project Leads | |
Julie Maynard | |
Jonas Holger Poulsson | jhop@novonordisk.com |
Sopan Kaith | sopan.kaith@tcs.com |
Wendy Dobson (PHUSE Project Manager) |
Objectives & Deliverables | Timelines |
Kick Off Project | April 2021 |
Template & Completion Guidelines | October 2021 |
Examples | December 2021 |
Problem Statement FDA drafted the initial Bio-research Monitoring Technical Conformance Guide in December 2017, with an updated version published in July 2020 (https://www.fda.gov/media/85061/download). The guide provides specifications for preparing and submitting the following components in electronic format that are used by FDA for planning of Bio-research Monitoring (BiMO) inspections.
NDA, BLA, and supplemental submissions to FDA require BiMO as a critical part of the electronic application. There is currently a lack of clarity, as each sponsor will have defined their own approach to the generation of this content, especially where there is a need to interpret the Technical Conformance Guide. Problem Impact This need for interpretation leads to inconsistencies between sponsors when submitting this content to the Agency. Potentially, this results in the need for sponsors to provide additional clarification to the Agency subsequent to the submission of the content. |
Project Members | Organisation | Project Members | Organisation |
Aatiya Zaidi | Gilead | Michael Johnson | FDA |
Amie Sagady | Takeda | Meng Li | AstraZeneca |
Aohra Monceaux | Sanofi | Nancy Bauer | Boehringer Ingelheim |
Barbara Lockley | Industry | Nigel Montgomery | Roche |
Bhanu Kannan | FDA | Phil Liu | AstraZeneca |
Bei Yu | FDA | Phyllis Smetana | UCB |
Cara Alfaro | FDA | Randi McFarland | ICON |
Cathy Michalsky | Trevena | Sai Ma | Bayer |
Chunying Yin | Janssen Research & Development | Shreetam Sheregar | Covance |
Cynthia Kleppinger | FDA | Srinivasan Ramasubramanian | AbbVie |
Dmitry Golubovsky | Teva Pharm | Stanley Brill | Janssen Research & Development |
Karen Bleich | FDA | Steve Fitzpatrick | Novartis |
Kathryn Knuckles | Eli Lilly | Steven Clark | Astellas |
Kirsty Wall | GSK | Todd Rider | BMS |
Jack Field | AstraZeneca | ||
Lin Yuan | Astellas | ||
Lisa Zhou | Janssen Research & Development |
CURRENT STATUS Q12021 |
Team are due to kick off their project 21st April. Sections of the White Paper will be assigned to project members to work offline together and curate. Bi weekly calls will be established from 19th May. |