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 |
. |
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 | MembersLeads | Company |
Amie Sagady | Takeda | |
Bei Yu | FDA | |
Cara Alfaro | FDA | |
Chunying Yin | Janssen Research and Development | |
Cynthia Kleppinger | FDA | |
Dmitry Golubovsky | Teva Pharm | |
Karen Bleich | FDA | |
Kirsty Wall | GSK | |
Jack Field | AstraZeneca | |
Jean Mulinde | FDA | |
Lee Pai-Scherf | FDA | |
Lin Yuan | Astellas | |
Lisa Zhou | Janssen Research and Development | |
MdRashedul Hasan | FDA | |
Michael Johnson | FDA | |
Meng Li | AstraZeneca | |
Nigel Montgomery | Roche | |
Phil Liu | AstraZeneca | |
Phyllis Smetana | UCB | |
Randi McFarland | ICON | |
Sai Ma | Bayer | |
Shreetam Sheregar | Covance | |
Sopan Kaith | Roche | |
Srinivasan Ramasubramanian | AbbVie | |
Stanley Brill | Janssen Research and Development | |
Steven Clark | Astellas | |
Todd Rider | BMS | |
Aohra Monceaux | Sanofi||
Julie Maynard, Johnson & Johnson | jmaynar1@its.jnj.com | |
Sopan Kaith, Alexion AstraZeneca Rare Disease | sopan.kaith@alexion.com | |
Nicola Newton, PHUSE Project Assistant |
| ||||||
|
Published Deliverables | |
---|---|
Bio-research Monitoring Data Reviewers Guide (BDRG) Package | Version 3.0, 28 June 2023 |
Bio-research Monitoring Data Reviewers Guide (BDRG) Package | Version 2.0, 22 June 2022 |
Bio-research Monitoring Data Reviewers Guide (BDRG) | Version 1.0, 05 Jan 2020 |
Objectives & Deliverables | Timelines |
Publication of BDRG v3.0 | Q2 2023 |
Presentation of BDRG v.30 in PHUSE June Webinar Wednesday | Q2 2023 |