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.

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Currently 6,832 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 Utrecht - 10th Oct, Chennai - 12th Oct, Cincinnati - 24th Oct Registration is open Registration is open 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 Deliverable out for Public Comment Best Practices for Quality Control & Validation: Closing date, 14th November PHUSE Webinars - Upcoming events and past presentations & recordings New The PHUSE Key Performance Indicators & Metrics Project has established a set of common data reporting metrics which are more detailed than industry-wide metrics, therefore allowing a greater level of granularity in our project reporting, and business process management. These metrics and their definitions are issued annually as a survey to life sciences industry companies in order to collect their information. The Year 2 survey is now being distributed to collate information from 20+ companies. Should you wish your company to participate, contact workingroups@phuse.eu. New The PHUSE/FDA Data Science Innovation Challenge provides a framework and an opportunity for the greatest minds in the data sciences arena to come together and collaborate intensively on projects during a defined time frame to create usable scripting that results in a functional approach to answer the scientific questions posed by a number of challenges. We are inviting people to join this challenge, to work on prototypes, and to present their proof-of-concepts or solutions at the PHUSE Annual US Connect Event, March 2020 in Orlando. Visit the innovation website for more information. Are you a PHUSE member? Log in to your account and visit the members blog to find a summary of all the latest news within the industry. EU Connect - With just 4 weeks to go, plans for our event are well underway. Discounted hotel rates are limited, register here. 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 WendyDobson, 10/17/2019