Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Image Removed

...

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

...

...

...

Data Transparency Summer Event 2022

...

Data Transparency Summer Event: Last chance to register! Taking place 28-30 June, this virtual and free event is not one to be missed. Click here to view the full agenda and to register. 

...

...

CSS 2022

...

CSS: This year's PHUSE/ FDA CSS takes place 19-21 September. To find out more, take a look at the agenda on the PHUSE website. For this event, the reduced Early Bird rate ends 1 July. Don't miss out, Click here to register! 

...

The Role of the Statistician and Statistical Programmer in Real-World Data Analysis:

The Real World Evidence project, part of the Emerging Trends and Technologies Working Group, presents the next PHUSE Community Forum, taking place 6 July, 15:00 (BST)/ 10:00 (EST).

Use of real-world data in regulatory submissions is growing. Real-world data provides unique insights which can be used for informed decision-making, resulting in faster drug approval. However, the nature of real-world data is quite different from that of clinical trial data. While the latter can be controlled at all stages, from collecting to reporting, this is not the case for real-world data. This imposes many challenges including pre-study alignment with regulatory agencies regarding validity of the data used. How does this affect the roles and corresponding responsibilities of various cross-functional clinical team members?

This meeting will start with a 30-minute presentation focused on the changes necessary
to use real-world data followed by a forum discussion on how this affects
the role of the statistical programmer and the statistician.

Date: 6 July 

Time: 15:00 (BST)/ 10:00 (EST) 

Register here!

Image Removed

                                        

...

Recently Published Deliverables

...

Bio-research Monitoring Data Reviewers Guide (BDRG) – The Optimizing the Use of Data Standards Working Group and the PHUSE BIMO Project Team are pleased to announce the publication of the Bio-research Monitoring Data Reviewer’s Guide (BDRG) Package. This reviewer’s guide was created to provide the industry with a consistent way and usable format for communicating information concerning the Bio-research Monitoring (BIMO) data to regulatory agency reviewers. The BDRG package includes an Introduction and Overview, Template, Completion Guidelines and three Examples.

...

Recommendations for SEND Dataset QC Best Practices – The SEND Dataset QC Best Practices project within the Nonclinical Topics Working Group have been busy working on a new deliverable which has recently been published. The White Paper provides key insights into current QC activities performed by industry as well as best practice recommendations for QC procedures. The aim is to promote more consistent QC procedures to help regulatory reviewers be more confident the SEND data accurately represents the data in the study report.

...

SDTM ADaM Implementation FAQThe SDTM ADaM Implementation FAQ project, under the Optimizing the Use of Data Standards Working Group, has published a new response to a question they received under Validation/Conformance Rules. The question is based on whether an SDTM domain that is in the SDTM IG v3.3 be used for a study that is using the SDTM IG v3.2 to map the study data.

...

Image Removed

...

For more information on the PHUSE Working Groups and their projects, click here. If you would like to become a valued member of PHUSE and volunteer for one or multiple projects, please email: workinggroups@phuse.global

...

PHUSE Working Group Co-Lead

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.

PHUSE Working Group Project Co-Lead

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.

...

Risk Based Quality Management

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)

Info

Information and Registration

Real World Evidence

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)

Info

Information and Registration

pharmaverse

Hackathon: pharmaverse Hackathon series featuring the {aNCA} package

9, 16 & 23 July 9:00-10:00 (EDT) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)

Info

Information and Registration

Data Transparency Autumn Event

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.

Info

Information and Registration

Real World Data Autumn Event – Save the Date

The Real World Evidence Working Group is preparing for its upcoming multi‑day virtual event, taking place 30 September–1 October 2026 at 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST).

Join the PHUSE Community to explore the evolving landscape of real-world data (RWD), including its growing role in clinical research and regulatory decision-making. This event will bring together global experts to share insights, practical approaches, and real-world applications of RWD.

Info

Information and Registration

...

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.

Info

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

...

Image Removed

...

Working Groups Latest Report: Q12022

...

.

...

June 

Previous 2022 Monthly Mailings 

...

PHUSE Blogs

PHUSE Diversity & Inclusion Survey

...

Can Clinical Data processed with R be Used in a Regulatory Submission?

...