Working Groups Events Report – Q4 2025

Real World Evidence

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

This Community Forum explored the following topics:

Evaluating RWD Providers – RWE is shaping research and regulation. However, reliable evidence depends on rigorous assessment of RWD. Key criteria includes data quality, provenance, transparency, privacy and governance. Trial emulation requires data that supports eligibility and control for confounding. Clear contracting and usage terms, especially for AI applications, are essential.

Submitting RWD – RWD use in NDAs/BLAs is growing, yet submissions pose challenges to reviewers. Practical guidance will be shared to enhance the submission and review process.

View the presentations and recordings on the PHUSE Archive.

Data Visualisation & Open Source Technology

Exploring the Synergy of Generative AI and the teal Framework in Pharma

Advanced technologies such as Generative AI are rapidly gaining momentum within the pharmaceutical industry. Similarly, the adoption of the teal framework for data visualisation is increasing across the sector. Many companies are now exploring how AI can enhance the efficiency, accessibility and usability of the teal framework, with the goal of enabling better decision-making and driving innovation.

View the presentations and recordings on the PHUSE Archive.

Safety Analytics  

This webinar explored the following topics:

Analysis & Displays for Hepatotoxicity – The Analysis & Displays for Hepatotoxicity project within PHUSE’s Safety Analytics Working Group developed two white papers outlining analyses to assess potential drug-induced liver injury (DILI). Stage 1 focused on analyses to rule out DILI with reasonable medical probability, while Stage 2 explored additional evaluations when DILI remained unresolved. The presentation summarised the Stage 1 paper and introduced the hepatotox tool, designed to generate the tables and graphs specified in both stages.

AE Groupings in Safety (AEGiS) – The AE Groupings in Safety (AEGiS) project team within the PHUSE Safety Analytics Working Group produced a white paper discussing the selection and use of published MedDRA queries (e.g. SMQs, OCMQs) and, where necessary, custom queries for clinical trial safety assessments. The session presented a high-level summary and key recommendations.

View the presentations and recordings on the PHUSE Archive.

As we look ahead to 2026, we are excited to announce three multi-day events alongside the first-ever Working Group collaboration at the US Connect. These initiatives will provide unparalleled opportunities for knowledge sharing, networking and innovation across our Community.

29 January 2026 – Register here

The Real World Evidence Working Group is back with another Community Forum, this time exploring The Causal Roadmap, Targeted Learning and TMLE: What Is That All About?  

22–26 March 2026 – Register here

PHUSE Pavilion™ at the US Connect: Experience a new kind of collaboration through PHUSE Pavilion™ – dynamic, themed spaces that serve as ‘conferences within the conference’. Each Pavilion is a self-curated, branded environment, hosted by a leading organisation or interest group, designed to deliver deep, engaging content in an interactive format.

10–12 February 2026 - Save the date

The Nonclinical Topics Working Group are pleased to announce the launch of a new multi-day virtual event. This event will provide an in-depth platform for exploring key nonclinical topics, fostering collaboration and sharing best practices across the industry. The event is designed to deliver engaging sessions and interactive discussions. Stay tuned for more information coming soon.

15–17 September 2026 – Save the date

The Data Transparency Autumn Event will return for its annual instalment, continuing the tradition of bringing our Community together to explore the latest developments in the field. We are excited to welcome even more insightful contributions from experts across the industry.

30 September to 1 October 2026 – Save the date

The Real World Evidence Working Group will be hosting its second multi-day virtual event. This event will bring together cross-industry experts to share insights, updates and best practices in the use of real-world data and real-world evidence. Call for Speakers will open in March.

Stay tuned for more details and registration information via our events page.