Hot Topics

Are you passionate about data standards and excited by the potential of emerging technologies to optimise their implementation? PHUSE is seeking a motivated and collaborative Co-Lead to help guide the Optimizing the Use of Data Standards Working Group. This is a unique opportunity to shape impactful industry initiatives, work with global experts, and drive innovation in data standards.

As a Working Group Co-Lead, you will play a central role in driving the success of multiple projects aligned with advancing the use of data standards. You will collaborate closely with Project Leads, the PHUSE Office, and leadership committees to ensure initiatives are well defined, well supported, and delivered effectively to the broader community.

We encourage applications from individuals who:

• Have a strong interest in or experience with data standards

• Are curious about and engaged with emerging technologies and their application to data standards

• Enjoy collaborating, leading and influencing across global, cross-functional teams

• Are proactive communicators and enthusiastic about driving community engagement.

For more information, visit Optimizing the Use of Data Standards or contact workinggroups@phuse.global.

To apply, please send a brief summary of interest and your qualifications to workinggroups@phuse.global by 3 July.

The Optimizing the Use of Data Standards Working Group is seeking a Co-Lead to oversee maintenance of the SDSP (Study Data Standardization Plan) package under the Management of ODS Regulatory Referenced Deliverables (MRRD) project. Co-Leads will work under guidance of the MRRD Project Lead and are asked to serve two years in the role.  Responsibilities include:

• Reviewing updates to regulatory documents where PHUSE deliverables are referenced to ensure they are aligned

• Identifying any updates that are required due to updated regulatory documents or PHUSE member feedback

• Discussing the updates with the MRRD project team for agreement and cross-document alignment

• Overseeing the updates and publishing of deliverables.

For more information, go to Management of ODS Regulatory Referenced Deliverables or contact workinggroups@phuse.global.

To apply, please send a brief summary of interest and your qualifications to workinggroups@phuse.global by 14 July.

Webinar: Quality Tolerance Limits (QTLs): Setting the Threshold

23 June 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)

Community Forum: Real World Evidence Meets AI and Privacy

9 July 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)

The Data Transparency Working Group is preparing for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST).

The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data.

Join us for the return of the Real World Evidence Working Group’s multi‑day virtual event on 30 September–1 October 2026. The event will run from 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST).

Registration will open 17 June.

The SEND Industry Feedback Survey project, under the Nonclinical Topics Working Group, is looking for volunteers to support this exciting initiative.

This project will help gather valuable industry insights and feedback to support future discussions and improvements within the SEND space. If you are interested in contributing, collaborating with peers, and helping shape this project, we’d love to hear from you.

Find out more information about the project on the Volunteer Board. To get involved, please complete the New Member Onboarding Form.

If you would like to get involved in a PHUSE Working Group Project, please explore the projects via the Volunteer Board and contact the PHUSE Office on workinggroups@phuse.global to express your interest. 

Working Group 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. 

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: 

• The projects must address significant research issues relevant to Computational Science

• The project must not attempt to address FDA policy issues

• There must be at least one Project Lead personally involved in planning and carrying out the project

New projects can be submitted anytime during the year, click here to submit.