Industry Experiences Submitting Standardised Study Data to Regulatory Authorities
- 1 Project Overview
- 2 Discussion Forum
- 3 Project Leads
- 4 Project Members
- 5 Project Updates
- 6 Objectives and Timelines
- 7 Project Activities
- 8 Meeting Minutes
- 9 Archived Content
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:
- The Right Post in the Right Place
- The Wiki
- The Forum
- Using Your Voice
- The Wiki - An Encyclopedic Voice
- The Forum - A Subjective Voice
- Respect Thy Neighbor
- Share and Share Alike
- 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
3. Respect Thy Neighbor
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!
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Last revision by WendyDobson, 2018-04-17
|Todd Case||Project Lead||Vertexfirstname.lastname@example.org|
|Vincent Guo||Project Lead||Novartis||Vincent.Guo@novartis.com|
|Wendy Dobson||Project Manager||PhUSEemail@example.com|
|Cathy Michalsky||Participant||Advanced Clinicalfirstname.lastname@example.org|
|Jerry Salyers||Participant||Data Standards Consulting||Jerry.Salyers@datastandardsconsulting.com|
|Kiran Kumar Kundarapu||Participant||Merck||Kiran.Kundarapu@merck.com|
|Lisa Brooks||Participant||Iris Staticalemail@example.com|
|Nate Freimark||Participant||The Griesser Group||Nfreimark@thegriessergroup.com|
|Soumya Rajesh||Participant||Syneos Healthfirstname.lastname@example.org|
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
|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.|
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: 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