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, 2020-07-20

Project Leads

Name Role Organization E-mail
Todd Case Project Lead Vertex
Vincent Guo Project Lead J&J
Wendy Dobson PHUSE Project Manager PHUSE

Project Members

Name Role Organization E-mail Name Role Organization E-mail
Albert Chau Participant Datacision Angelica Hoch Participant JNJ
Angelo Tinazzi Participant Cytel Annapurna Ravi Participant Syneos Health
Amy Adyanthaya Participant Independent Ajay Gupta Participant PPDI
Bhavin Busa Participant Softworldinc Bhupendra Mistry Participant Roche
Brenda Baldwin Participant FDA Bhanu Kannan Participant FDA
Cathy Michalsky Participant Advanced Clinical Cynthia Stroupe Participant UCB
David Schmeidler Participant Regenxbio David Izard Participant GSK
Salma Fnu Participant Medimmune Wenyu Hu Participant Merck
Janet Low Participant Merck Jerry Salyers Participant Data Standards Consulting
John Franchino Participant Roche
Kiran Kumar Kundarapu Participant Merck Lucy Liu Participant Vertex
Ling Chen Participant Vertex Katherine Xie Participant Abbvie
Kristi Helekivi Participant Statfinn Sanjiv Ramalingam Participant Independent
Lisa Brooks Participant PHUSE Kirk Prutzman Participant FDA
Nhi Beasley Participant FDA Kristin Kelly Participant Pinnacle21
Tanvir Ahmed Participant FDA Ting-Yuan Liu Participant Gilead
Zhihai Zhang Participant Independent Srinivasa Pillarisetty Participant Astrazeneca
Nicole Gallegos Participant Merck Nate Freimark Participant The Griesser Group
Tanja Petrowitsch Participant Bayer Soumya Rajesh Participant Amgen
Vishnu Kollisetti Participant PPDI Cordula Massion Participant Analytical Software
Ellen Asam Participant Merck Michael Calcagno Participant Gilead
Monica Massaro Participant Blue Bird Co Jennifer Britt Participant Gilead Jennifer.Britt@Gilead.Com
Sujit Khune Participant Novonordisk Nancy Bauer Participant Boehringer-Ingelheim
Robin Mann Participant GCE Solutions Yoshiko Kitagawa Participant ONO Pharmaceuticals
Warwick Benger Participant GSK Bart Creemers Participant JNJ
Yasuhiro Iijima Participant Novartis Lisa Carey Participant JNJ
Wilfried Willems Participant JNJ Susheel Arkala Participant MMS Holdings
Shiva Setti Participant MMS Holdings

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
White Paper Q4 2019
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:

Meeting Minutes

Archived Content