Working Groups Hot Topics |
PHUSE collaborations are organised into a number of specialist Working Groups, each with a broad topic area. The Working Groups have specific projects designed to achieve a set of particular objectives. This page will highlight the latest news and information from our projects. Participation is open to anyone who wants to contribute and if you would like to get involved, please email workinggroups@phuse.global. |
PHUSE/FDA CSS 2024 | ||||||
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Registration for the PHUSE/FDA CSS 2024 is open! Come and be a part of the PHUSE/FDA Computational Science Symposium 2024 (CSS) taking place 3–5 June in Silver Spring, MD. Share your insights, discoveries and solutions with the PHUSE Community, who are eager to learn and collaborate.
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Open Source – Open Source in Pharma, Regulatory Acceptance and Validation | ||||||
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Registration for the Open Source Open Forum is open! The Open Source Technology in Clinical Data Analysis (OSTCDA) project is hosting their third Open Forum: Open Source in Pharma, Regulatory Acceptance and Validation, they will be addressing the following questions:
Come and be a part of the our next virtual Open Forum on 14 June at 15:00 (BST) / 10:00 (EDT).
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Data Transparency Autumn Event 2024 |
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Call for speakers is now open for the Data Transparency Autumn Event. Don't miss out on the opportunity to contribute your expertise, innovations, and research by submitting your 150-word abstract before 14 June. Need guidance? Explore the curated topics below from PHUSE's Data Transparency Leads to spark inspiration for your standout abstract.
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New Deliverables |
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The Quality and Reusability of Real World Data project within Real World Evidence, has just published a new Blog Post, 'Understanding the Data Quality Issues in Real World Data through Real World Examples'. This blog takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using RWD. The Best Data Practices for Rare Disease Patient Foundations and Researchers within the Real World Evidence Working Group, has published a new deliverable in the form of a Poster. The Poster provides an overview of Ensuring Registry Data Relevance and Reliability for Regulatory Use. The PHUSE data standards community, which is comprised of leaders and experts responsible for the governance and implementation of data standards across the biopharmaceutical industry, have authored and new White Paper. The Data Standards White Paper highlights current challenges in data standardisation across the biopharma industry and identify opportunities where we can work together to tackle them. The Educate the General Population on Data Privacy and Data Sharing project, within the Data Transparency Working Group have published Video 2 of their video series. Titled 'What Will I Receive and When Will I Receive It?’ this video carries on the discussion from Video 1 and covers topics such as the concept of consent to participate in a clinical trial, an overview of trial design and treatment procedures to develop a strong foundational understanding of clinical trials. |
Calling for Feedback |
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The Treatment Emergent Definitions Recommendations project within Safety Analytics Working Group has produced a White Paper 'Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials'.This document defines treatment-emergent events in Phase 1 to 4 clinical trials and integrated summary documents across therapeutic areas. The recommendations described herein were based on the authors’ collective experiences and a survey conducted by the PHUSE Treatment-Emergent Definition Recommendations project team [2] to solicit input from respondents on various TEAE scenarios for a simple clinical study design. Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 7 June |
Volunteer Opportunities | |
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TheEstimands for RWD/RWE, a new project within Real World Evidence Working Group is now calling for volunteers. The focus of this project is on best practices of RWD Estimands, not on their implementation using data standards. The team formed will have representation from the PHUSE Implementation of Estimands (ICH E9 (R1)) using Data Standards project team, which has a White Paper nearing publication and the Estimands Implementation Working Group (EIWG) sub team on HTA and RWE. Both with Estimands expertise, along with representation from teams under the RWE Working Group. If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 14 June Multiple projects within Working Groups are open to join. PHUSE welcomes new members who can apply their knowledge to bring fresh ideas and contribute to the ongoing work of PHUSE projects. For more information, click here, read the Welcome Pack or email workinggroups@phuse.global. |
Announcement |
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PHUSE Communications | |
Working Groups Report: Includes project updates, recent and upcoming deliverables and future plans for each Working Group. | |
Monthly Mailings: The monthly newsletter. Here you will find a full update from each month of the year, easily accessible and divided into key areas of PHUSE. | |
PHUSE Blogs: Fancy a quick read? A blog is a perfect way to catch up on all things Working Groups. Get the lowdown on the latest events from across the globe and stay updated on industry topics brought to you by industry professionals. |
New Project Idea? |
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Initiate and lead a new project under the PHUSE Working Groups umbrella. The new project must address problems of significant relevance to computational science related to drug, biological and device development and must meet all of the guidelines for projects within the collaboration, including the following mandatory requirements:
New projects can be submitted anytime during the year, click here to submit. |