PHUSE Wiki

Welcome to the PHUSE Wiki

The PHUSE Wiki is an PHUSE/FDA/Industry collaboration to provide a medium to share information specifically relating to clinical trial informatics.

PHUSE Website	Steering Committee	Useful Information	GPP

Currently 6,827 users are helping to Connect, Share, Advance clinical informatics.

All content on this wiki is non-binding. All content expresses opinions of users and not necessarily that of their employer nor PHUSE. See our Disclaimers page

Need help with the Wiki? Ideas to Improve? The Wiki Team are always looking at ways to improve this site. We want to make this user friendly, current and of benefit to PHUSE Members. If you have a question, query or need help, please use this 'Discussion Forum'. A member of the team will do their best to assist and all feedback is welcome. Equally should you wish to be part of the team, contact wendy@phuse.eu PHUSE Events Beerse, Belgium 11th September 2019, North Wales, Pennsylvania 26th September 2019 Registration is open Registration & Call for Papers open - Abstract deadline 13th September Become a PHUSE Member There are many benefits to becoming a PHUSE member. Here's just a few reasons why you want to become part of something amazing Free attendance to a range of Single Day Events held across US, EU and Asia Access to PHUSE Blog Full access to PHUSE Archives Participation in our annual US & EU Connects and the US Computational Science Symposium To become a member, sign up here

Create a new Wiki page Enter the page title: Working Groups News ANNOUNCEMENTS PhUSE Webinars - Upcoming events and past presentations & recordings New Project:  The new Knowledge Repository project is calling for volunteers. The group aims to serve as a quick reference guide for clinical development process, underlying regulations, industry standards and medical knowledge. Interested in joining? Contact workinggroups@phuse.eu to join!  Deliverables The Clinical Trials Data Transparency Toolkit project are soliciting feedback on the Best Practices Guide which aims to describe the five key elements of clinical disclosure and transparency. Visit the PHUSE website to download the guide. Are you a PHUSE member? Log in to your account and visit the members blog to find a summary of CSS and all the latest news within the industry. EU Connect - With just 8 weeks to go, plans for our event are well underway. Discounted hotel rates are limited, register here. US Connect - Registration and Call for Papers are now open for the US Connect 2020, click here for more information. Industry News GDPR has gone live. Please review PHUSE Privacy Policy PHUSE Collaborations: CDISC FDA HL7 PSI STARDOG Here's the link to the latest version of the Technical Conformance Guide (TCG) which has been updated by the FDA March 2019 Refuse to File: NDA & BLA Submissions to CDER. Guidance for Industry. Formal meetings between FDA and Sponsors or Applicants of PDUFA Products Best Practices for communication between IND Sponsors and FDA during Drug Development

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Last revision by Laurenwhite, 09/19/2019