Working Group Events
The Working Groups have hosted multiple successful events in the past quarter, which have covered several topics within the industry. This includes two community forums, a Dataset JSON webinar and the coveted DT Winter Event. There were a total of 778 Attendees across all four of these events. Coming up in the future, there are two community forums. Including the Innovations in Healthcare in the Age of Generative AI from Emerging Trends & Technologies Working Group, taking place on 17 April. As well as the Is My Data Fit For Purpose: View From a Data Vendor by the Real World Evidence Working Group which will be taking place on 18 April

Working Group Events

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

This includes two community forums, a Dataset JSON webinar and the coveted DT Winter Event. There were a total of 778 Attendees across all four of these events.

Coming up in the future, there are two community forums. Including the Innovations in Healthcare in the Age of Generative AI from Emerging Trends & Technologies Working Group, taking place on 17 April. As well as the Is My Data Fit For Purpose: View From a Data Vendor by the Real World Evidence Working Group which will be taking place on 18 April

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 and Kris 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.
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.

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 and Kris 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.

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.

Data Transparency Winter Event
Since the first PHUSE Data Transparency Event in 2020, PHUSE has continued to strengthen its place as the world’s largest home for data transparency events, by sharing vital knowledge of the field and creating a space where questions can be asked and challenges addressed. The Data Transparency Winter Event returned for its eighth instalment, with presentations from a range of industry professionals. There were 322 attendees from diverse backgrounds and experiences across this multi-day event. If you didn’t have the chance to attend, the presentations and the recordings are on the PHUSE Archive.

Data Transparency Winter Event

Since the first PHUSE Data Transparency Event in 2020, PHUSE has continued to strengthen its place as the world’s largest home for data transparency events, by sharing vital knowledge of the field and creating a space where questions can be asked and challenges addressed. The Data Transparency Winter Event returned for its eighth instalment, with presentations from a range of industry professionals. There were 322 attendees from diverse backgrounds and experiences across this multi-day event. If you didn’t have the chance to attend, the presentations and the recordings are on the PHUSE Archive.

Dataset-JSON Webinar
Dataset-JSON Webinar The Dataset-JSON Webinar gave all the sub-teams within the project the opportunity to come together and give their updates. There were 281 attendees. Introduction, presented by Stuart Malcom, Veramed Pilot Submissions Status Update, presented by Sam Hume, CDISC Technical Implementation Topics, presented by Jesse Anderson, FDA Business Case, presented by Marguerite Kolb, Johnson & Johnson Strategy for Future Development, presented by Nicole Thorne, BMS

Dataset-JSON Webinar

The Dataset-JSON Webinar gave all the sub-teams within the project the opportunity to come together and give their updates. There were 281 attendees.
- Introduction, presented by Stuart Malcom, Veramed
- Pilot Submissions Status Update, presented by Sam Hume, CDISC
- Technical Implementation Topics, presented by Jesse Anderson, FDA
- Business Case, presented by Marguerite Kolb, Johnson & Johnson
- Strategy for Future Development, presented by Nicole Thorne, BMS