Industry Experiences Submitting Standardised Study Data to Regulatory Authorities

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Project Overview

FDA & PMDA require standardised study data for certain regulatory submissions. Industry approaches to meeting these requirements vary across companies. This project provides a collaborative, non-competitive forum for industry to share submission experiences including, but not limited to submission planning, interactions with the regulators, test submissions, regulator feedback etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. Historically, biometrics departments have not directly interacted with regulators, but relied on internal regulatory affairs departments as an intermediary. The project will examine different communication use cases and make recommendations as to ensure effective exchange of information.

Guidelines for using Forum

Discussion Forum

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Last revision by WendyDobson, 2018-07-9

Project Leads

Name Role Organization E-mail
Todd Case Project Lead Vertex todd_case@vrtx.com
Vincent Guo Project Lead Novartis Vincent.Guo@novartis.com
Wendy Dobson Project Manager PhUSE wendy@phuse.eu

Project Members

Name Role Organization E-mail
Albert Chau Participant Datacision albert@datacision.co.uk
Angelica Hoch Participant JNJ AHoch@its.jnj.com
Angelo Tinazzi Participant Cytel Angelo.Tinazzi@cytel.com
Annapurna Ravi Participant Syneos Health annapurna.ravi@syneoshealth.com
Amy Adyanthaya Participant Independent Amy.Adyanthaya@biogen.com
Ajay Gupta Participant PPDI Ajay.Gupta@ppdi.com
Bhavin Busa Participant Softworldinc bbusa@softworldinc.com
Bhupendra Mistry Participant Roche Bhupendra.Mistry@roche.com
Brenda Baldwin Participant FDA Brenda.Baldwin@fda.hhs.gov
Bhanu Kannan Participant FDA Bhanu.Kannan@fda.hhs.gov
Cathy Michalsky Participant Advanced Clinical cmichalsky@advancedclinical.com
Cynthia Stroupe Participant UCB cynthia.stroupe@ucb.com
David Schmeidler Participant Regenxbio Dschmeidler@regenxbio.com
David Izard Participant GSK David.x.izard@gsk.com
Salma Fnu Participant Medimmune salmaf@medimmune.com
Wenyu Hu Participant Merck Wenyu_hu@merck.com
Janet Low Participant Merck Janet_Low@merck.com
Jerry Salyers Participant Data Standards Consulting Jerry.Salyers@datastandardsconsulting.com
John Neville Participant CDISC Jneville@cdisc.org
John Franchino Participant Roche John.Franchino@roche.com
Kiran Kumar Kundarapu Participant Merck Kiran.Kundarapu@merck.com
Lucy Liu Participant Vertex Lucy_Liu@vrtx.com
Ling Chen Participant Vertex lingyun_chen@vrtx.com
Katherine Xie Participant Abbvie Kang.xie@abbvie.com
Kristi Helekivi Participant Statfinn Kristi.Helekivi@statfinn.com
Sanjiv Ramalingam Participant Independent sanjivramalingam@gmail.com
Lisa Brooks Participant Iris Statical lisa@irisstatcomp.com
Kirk Prutzman Participant FDA Kirk.Prutzman@fda.hhs.gov
Nhi Beasley Participant FDA Nhi.Beasley@fda.hhs.gov
Kristin Kelly Participant Pinnacle21 KKelly@pinnacle21.com
Tanvir Ahmed Participant FDA Tanvir.Ahmed@fda.hhs.gov
Ting-Yuan Liu Participant Gilead Ting-yuan.liu@gilead.com
Zhihai Zhang Participant Independent zhzhang22@gmail.com
Srinivasa Pillarisetty Participant Medimmune pillarisettysr@medimmune.com
Nicole Gallegos Participant Merck Nicole.Gallegos2@merck.com
Nate Freimark Participant The Griesser Group Nfreimark@thegriessergroup.com
Tanja Petrowitsch Participant Bayer Tanja.Petrowitsch@bayer.com
Soumya Rajesh Participant Syneos Health soumya.rajesh@syneoshealth.com
Vishnu Kollisetti Participant PPDI Vishnu.kollisetti@ppdi.com
Cordula Massion Participant Analytical Software cordula.massion@analytical-software.de
Ellen Asam Participant Merck ellen_asam@merck.com

Project Updates

This is a brand new project looking to kick off January 2018. We are calling for volunteers so if you are interested in supporting this project, please contact Todd or Wendy

Objectives and Timelines

Objective Timeline
Project Kick off and initial sharing of information Q1 2018 / 2018 US CSS
Submission FAQ Q3 2018 (ongoing)
White Paper Q4 2018
Communications of Deliverables SDE's, US CSS, PhUSE Connect, Website, Wiki, Mailshot.

Project Activities

Best Practices for Communication between IND Sponsors and FDA during Drug Development Guidance for Industry and Review Staff

Formal Meetings between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry
FDA Meeting....
FDA: Electronic Submissions and Data Standards Public Meeting on March 21, 2018, from 9 a.m. to 4 p.m held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Website: https://www.federalregister.gov/documents/2017/10/12/2017-21981/prescription-drug-user-fee-act-of-2017-electronic-submissions-and-data-standards-public-meeting

Meeting Minutes


Archived Content