Industry Experiences Submitting Standardised Study Data to Regulatory Authorities

From PhUSE Wiki
Jump to: navigation, search

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

These are the Five Guidelines for using this Forum and Wiki. Please take some time to read them over. The Five Guidelines are general principles to which users should adhere:

  1. The Right Post in the Right Place
    - The Wiki
    - The Forum
  2. Using Your Voice
    - The Wiki - An Encyclopedic Voice
    - The Forum - A Subjective Voice
  3. Respect Thy Neighbor
  4. Share and Share Alike
  5. Contribute, Contribute, Contribute!

1. The Right Post in the Right Place

This site has a few areas, each with a specific purpose. Please make sure you are posting in the right place. Here's a brief description to help:

  • The Wiki - the Wiki is a place for objective information. It is encyclopedic in nature. Please refrain from making subjective or biased statements in the Wiki.
  • The Forum - the Forum is a place for the expression of opinions and questions. If you have something to say or ask, this is the place! Of course, always be respectful.

2. Using Your Voice

After you have put the Right Post in the Right Place, be sure and contribute using the right voice!

The Wiki - An Encyclopedic Voice
When contributing to the Wiki, be sure and use a neutral point of view. Stick to the facts. For example, you might not particularly care for a certain style, but would like to contribute to the Wiki entry about it. In the Wiki entry, remain neutral and contribute only objective and historic facts. If you have an opinion about something, head on over to the Forum!

The Forum - A Subjective Voice
In the Forum, feel free to express any opinions or questions that may be on your mind. (Provided, of course, that they fall within the Terms of Use).

3. Respect Thy Neighbor

A simple rule to live by. Healthy debates are always good, but always remain respectful. Please contribute and express yourself freely, but things like name calling or threatening statements are not tolerated (and also violate the Terms of Use ). In addition, avoid edit wars. If a wiki page is continually being switched between multiple versions, discuss the differences. If a resolution cannot be made, consult a Moderator or Administrator.

4. Share and Share Alike

Information should be free, in the truest sense of the word. The interpretation of the word "free" doesn’t just mean "without cost". It also means free as in the freedom to do with it what you will. So feel free to copy, share and contribute to the information on this site.

5. Contribute, Contribute, Contribute!

The purpose of this site is to serve as a repository for information. The more contributions members of industry make, the stronger the community gets. Don't be afraid to edit a Wiki page, or express yourself in a Forum. That's the whole point of this site!

Discussion Forum


blog comments powered by Disqus

Last revision by WendyDobson, 2018-04-17

Project Leads

Name Role Organization E-mail
Todd Case Project Lead Vertex
Vincent Guo Project Lead Novartis
Wendy Dobson Project Manager PhUSE

Project Members

Name Role Organization E-mail
Albert Chau Participant Datacision
Angelica Hoch Participant JNJ
Angelo Tinazzi Participant Cytel
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
Fnu Salma Participant Medimmune
Hu Wenyu Participant Merck
Janet Low Participant Merck
Jerry Salyers Participant Data Standards Consulting
John Neville Participant CDISC
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 Iris Statical
Kirk Prutzman Participant FDA
Nhi Beasley Participant FDA
Kristin Kelly Participant Pinnacle21
Tanvir Ahmed Participant FDA
Ting-Yuan Liu Participant Gilead
Zhihai Zhang Participant Gilead
Srinivasa Pillarisetty Participant Medimmune
Nicole Gallegos Participant Merck
Nate Freimark Participant The Griesser Group
Tanja Petrowitsch Participant Bayer
Soumya Rajesh Participant Syneos Health
Vishnu Kollisetti Participant PPDI

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:

Meeting Minutes

Archived Content