20 February

Risk Based Quality Management

Make the Most out of Innovation and Ensure it’s Done Right!

Shawntel Swannack, Emmes

Recording

18 February

Emerging Trends & Innovation

Responsible AI in a Healthcare System

Dr. Nigham Shah, Stanford

Recording

28 January

Real World Evidence

RWD for Regulatory Decision-Making: Learnings from Use Cases and Demonstration Projects

Ulka Campbell, Aetion and Ben Ackerman, Johnson & Johnson

Recording coming soon.

2024 Working Group Webinars

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

20 November 

Safety Analytics

Recommendations for Adverse Event Collection and Treatment Emergent Definition

Bill Palo, AbbVie and Aimee Basile, Otsuka

Recording

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

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.

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

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.

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.

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

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.

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.

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. 

18 April 

Real World Evidence

Meet the Real-World Data Provider

Michèle Arnoe, IQVIA, Jeffrey Brown, TriNetX and Benjamin Forred, Sanford Research

Recording

17 April

Emerging Trends & Technologies

Innovations in Healthcare in the Age of Generative AI

Dr. Junshui Ma, Merck

Recording

21 February

Risk Based Quality Management

The Risk Based Monitoring Feedback Loop

Vera Pomerantseva, ZS Associates

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

18 January

Real World Evidence

RWD Quality Challenges – Different Perspectives

Dr Cheryl Grandinetti, FDA and Kris Wenzel, MMS

Recording