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

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

Forum

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Last revision by WendyDobson, 2018-04-17

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
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
Fnu Salma Participant Medimmune salmaf@medimmune.com
Hu Wenyu 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 Gilead Zhihai.Zhang@gilead.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

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