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Working Group Events

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Community Forums

Real World Evidence Community Forum – RWD Quality Challenges – Different Perspectives

This was the first Working Group event of the year, with 114 attendees listening to Dr Cheryl Grandinetti, FDA andKris Wenzel, MMS discuss the different opportunities in using real-world data in drug development. Both speakers shared their perspectives of both regulatory and data provenance.

The Working Groups have hosted multiple successful events in the past quarter, which have covered several topics within the industry.  

There are 3 events coming up within the Working Groups

Data Transparency Autumn Event 

  • The Data Transparency Autumn Event will take place from 17–19 September 2024. This virtual event provides a platform for attendees and presenters to foster meaningful interactions and collaborate on ideas. Presentations will be delivered across the three days in bitesize chunks from 15:00-17:30(BST) 10:00-12:30(EDT).

Community Forum – 11 July at 14:00(BST) 9:00(EDT)

Open Source Forum – 12 July at 15:00(BST) 10:00(EDT)

  • The Open Source Forums will be continuing into July on the topic of Regulatory Acceptance of Open-Source Submissions. Registration will open soon. 


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Community Forums
Emerging Trends and Technologies Community Forum 


Real World Evidence Community Forum 
  • Meet the Real-World Data Provider was the Real World Evidence Working Group’s second forum of the year. We heard from three speakers: Michèle ArnoeJeffrey Brown and Benjamin Forred. The forum covered topics related to data provision, including the challenges associated with delivering data to the end user and how the data provider can assist. The forum took place on 18 April, with 55 people in attendance. 




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Open source

PHUSE Open Source Technology in Clinical Data Analysis are running a series of Open Forums this year. The forums have been open to the public since April and will continue most months until October. Each forum explores different topics and investigates questions. The next forum will look at Regulatory Acceptance of Open-Source Submissions.

Risk Based Quality Management Community Forum – The Risk Based Monitoring Feedback Loop

  • The Risk Based Quality Management Working Group held their first Community Forum, with Vera Pomerantseva giving an excellent presentation on The Risk Based Monitoring Feedback loop. This was an interactive session with 61 attendees, many of whom asked questions and gave feedback.

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