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The Community Forum creates a space for the PHUSE Community to unite and discuss industry topics of interest in an informal setting. Alongside this, each Working Group will use Disqus to host offline discussions and continue sharing information.

The Community Forum events are

This event is free and

take

takes place virtually

over Zoom

. If you have any questions

on Community Forums

, contact workinggroups@phuse.global.

Upcoming Community Forum

Safety Analytics: Reimagining a Safety Submission – Vision of Interactive Safety Reviews – 27 March 2023
During this forum, you’ll hear about various efforts related to interactive safety reviews. This will then be followed by a discussion on the end goal, potential impact on submissions, and different models for creating and sharing interactive safety review tools. Register here

Community Forums

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Data Transparency: Data Privacy and Data Sharing in Clinical Trials – 21 February 2023
Data Transparency Working Group lead, Devaki Thavarajah, is the host of the Working Group’s first Community Forum. The Educate the General Population project have recently published two out of a series of six videos on Data Sharing in Clinical Trials and are calling for your feedback!

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To catch up on the previous Community Forums, visit the PHUSE archive


Previous Community Forums:

Date/ TimeWorking GroupTitleSpeakersRecordings

18 January

Real World Evidence

RWD Quality Challenges – Different Perspectives


Dr Cheryl Grandinetti, FDA andKris Wenzel, MMS


Recording

21 February

Risk Based Quality Management

The Risk Based Monitoring Feedback Loop

Vera Pomerantseva, ZS Associates


Recording

17 April


Emerging Trends & Technologies

Dr. Junshui Ma, Merck

Recording

18 April 

Real World Evidence

Michèle Arnoe, IQVIA, Jeffrey Brown, TriNetX andBenjamin Forred, Sanford Research

Recording
Safety Analytics: Reimagining a Safety Submission – Aggregate Safety Assessment Planning16 February 2023
In this Community Forum, PHUSE Safety Analytics Working Group Leads, Mary Nilsson and Greg Ball, as well as Barbara Hendrickson and Robert Gordon, introduced two new FDA premarket safety analytics documents. A discussion took place on how past and current efforts from cross-industry Working Groups can be leveraged to prepare the ecosystem for operationalising them. Join the post meeting discussion by sharing your comments on the Disqus Forum