Hot Topics

Community Forum: Getting the RWD We Need – From Both Sponsor and Regulator Perspectives

7 October at 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)

Working Group Webinar: Exploring the Synergy of Generative AI and the Teal Framework in Pharma

10 October at 10:00-11:00 (EDT) / 15:00-16:00 (BST) / 16:00-17:00 (CEST)

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here. 

'Please confirm instances that would define the OCCDS analysis dataset to be the Adverse Event sub-classification.'

Do you have a SDTM ADaM Implementation question? You can send your questions to the team by emailing workinggroups@phuse.global. 

The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group has produced a White Paper 'Cloud Services, A Framework for Adoption in the Regulated Life Sciences Industry'.

This paper sets out guidance on developing effective cloud exit strategies in the regulated life sciences industry. It explores how organisations can safeguard data security and integrity, maintain business continuity, meet compliance requirements, manage risks, and prevent vendor lock-in. By planning ahead, companies can stay resilient, flexible, and prepared for both planned migrations and unexpected provider changes.

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 10 October

The Applying Advanced Data Privacy Methods to Real World Data (RWD), a new project within the Real World Evidence Working Group, is now calling for volunteers.  

The goal of this project is to develop a comprehensive, cross-disciplinary resource to support individuals and organisations in applying advanced privacy-preserving techniques to real-world data (RWD). Given the evolving landscape of privacy regulations and the increasing complexity of data sources – including integrating machine learning (ML), artificial intelligence (AI) and large language models (LLMs) into healthcare pipelines – this project will serve as a critical foundation for advancing privacy-preserving data integration frameworks for RWD.

If you would like to volunteer or learn more about this project, email workinggroups@phuse.global. Closing date: 7 October. 

The Kick-Off Meeting for this project will be held on 8 October at 9:00-10:00 (EST) / 14:00-15:00 (BST) / 15:00-16:00 (CEST)

We’re looking for a Working Group Lead for our Real World Evidence Working Group. 

Working Group Scope

The Real World Evidence Working Group aims to support, address and answer pertinent questions around real-world evidence. The Working Group is dedicated to sharing across the PHUSE Community (through Community Forums) and aligning on the best industry practices. Some of the questions we intend to address are:

• What are the requirements, technologies and processes needed to use real-world evidence as a source for data analysis?

• What are the requirements, technologies and processes needed to incorporate real-world evidence into clinical trials?

• What are the requirements, technologies and best practices needed to support the use of real-world evidence as part of regulatory submissions?

Current Projects

• Applying Advanced Data Privacy Methods to Real World Data (RWD)

• Estimands for RWD/RWE

• Missing Data Imputation in RWD Exploration of Multiple Techniques on Open-Source Data

• RWD Guideline for Programming and Analysis Processes

• Submitting Real World Data 

• Quality and Reusability of Real World Data

• Using OMOP and Other Real World Data Standards to Support Regulatory Submissions

Working Group Lead Roles and Responsibilities 

You can learn about the role and the responsibilities here. If you are interested in this role or have any questions, workinggroups@phuse.global. Closing date: 7 October. 

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.