2024 Working Groups Webinar Archive

Date	Working Group/Project	Title	Speakers	Recordings

Date	Working Group/Project	Title	Speakers	Recordings
18 January	Real World Evidence	RWD Quality Challenges – Different Perspectives	Dr Cheryl Grandinetti, FDA and Kris Wenzel, MMS	Recording
1 February	Optimizing the Use of Data Standards	Dataset-JSON Project Status Update	Stuart Malcom, Veramed, Sam Hume, CDISC, Jesse Anderson, FDA, Marguerite Kolb, Johnson & Johnson and Nicole Thorne, BMS	Recording
21 February	Risk Based Quality Management	The Risk Based Monitoring Feedback Loop	Vera Pomerantseva, ZS Associates	Recording
17 April	Emerging Trends & Technologies	Innovations in Healthcare in the Age of Generative AI	Dr. Junshui Ma, Merck	Recording
18 April	Real World Evidence	Meet the Real-World Data Provider	Michèle Arnoe, IQVIA, Jeffrey Brown, TriNetX and Benjamin Forred, Sanford Research	Recording
26 April	Open Source Technology in Clinical Data Analytics (OSTCDA)	Open Source – Solutions of the People, by the People, for the People	Michael Rimler, PHUSE Open Source Technologies Director	Meetings are not recorded.
17 May	Open Source Technology in Clinical Data Analytics (OSTCDA)	Open Forum: Open Source in Pharma and Long-Term Dependability	Mike Smith, Pfizer	Meetings are not recorded.
14 June	Open Source Technology in Clinical Data Analytics (OSTCDA)	Open Forum: Open Source in Pharma, Regulatory Acceptance and Validation	Mike Smith, Pfizer	Meetings are not recorded.
11 July	Real World Evidence	Understanding the Complete Journey of RWD, from Data Source to Final Analysis	Jean-Marc Ferran, Independent Consultant, Berber Snoeijer, Clinline and Ariel Berger, Evidera	Recording
12 July	Open Source Technology in Clinical Data Analytics (OSTCDA)	Open Forum: Regulatory Acceptance of Open-Source Submissions	Katja Glaß, Katja Glass Consulting	Meetings are not recorded.
13 September	Open Source Technology in Clinical Data Analytics (OSTCDA)	Open Forum: What is the True Cost of Open Source?	Mike Stackhouse, Atorus Research	Meetings are not recorded.
25 September	Emerging Trends & Technologies	Regulatory Landscape of AI/ML in DHTs (Current Landscape, Knowledge Gaps, Best Practices for Regulatory Submissions, Challenges of Regulating AI)	Anindita Saha, FDA, MiRa Jacobs, FDA and Kausar Riaz Ahmed, Pfizer	Recording
11 October	Open Source Technology in Clinical Data Analytics (OSTCDA)	Open Forum: Open Source Technologies in Clinical Data Analysis	Michael Rimler, PHUSE Open Source Technologies Director	Meetings are not recorded.
24 October	Real World Evidence	RWD Sources – How the Genesis of Your Data Determines What Questions You Can Answer	Matthew Reynolds, Azimuth Research Group and Timothy Wolfe, Verantos	Recording
20 November	Safety Analytics	Recommendations for Adverse Event Collection and Treatment Emergent Definition	Bill Palo, AbbVie and Aimee Basile, Otsuka	Recording
21 November	Emerging Trends & Technologies	Responsive Regulation of AI in Drug Development	Lan Mu, University of Georgia, Jielu Zhang, University of Georgia, Marsha Samson, FDA and Jian Dai, Roche	Recording