Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

The Working Group Webinars and Community Forums provide a virtual space for the PHUSE Project Leads and Community to highlight and share industry topics of interest relating to their Working Groups. These webinars are free and take place virtually.

Details of upcoming webinars are listed below and will be shared via our social media channels. For any inquiries, please contact workinggroups@phuse.global.

To access past webinars, please visit the PHUSE archive.

Matthew Reynolds, Azimuth Research Group andTimothy Wolfe, Verantos

25 September 

Emerging Trends & Technologies

13 September

Open Forum: What is the True Cost of Open Source?

 Mike Stackhouse, Atorus Research

14 June 

Open Forum: Open Source in Pharma, Regulatory Acceptance and Validation

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

17 April

Vera Pomerantseva, ZS Associates

Dataset-JSON Project Status Update

Date

Working Group/Project

Title

Speakers

Recordings

21 November  18 January 

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

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.

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

Open Source Technology in Clinical Data Analytics (OSTCDA)

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

Open Source Technology in Clinical Data Analytics (OSTCDA)

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

Recording

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

Recording

1 February

Optimizing the Use of Data Standards

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 andKris Wenzel, MMSInnovation

Submitting Real-world Data

Parag Shiralkar, Sumptuous Data Sciences & Jeff Abolafia, Pinnacle 21

Recording

16 February 

Safety Analytics

Reimagining a Safety Submission – Aggregate Safety Assessment Planning

Greg Ball, ASAPprocess, Mary Nilsson, Eli Lilly, Mac Gordon, Janssen Research & Development & Barbara Hendrickson, University of Chicago

Recording

21 February 

Data Transparency

Data Privacy and Data Sharing in Clinical Trials

Devaki Thavarajah, Instem & Deborah Collyar, Founder and President, Patient Advocates in Research (PAIR)

Recording

27 March 

Safety Analytics

Reimagining a Safety Submission – Vision of Interactive Safety Reviews

Greg Ball, ASAPprocess, Mary Nilsson, Eli Lilly,  Wei Wang, Eli Lilly,  Xiangyun Wang, Genentech, Raj Kiran, Takeda, Melvin Munsaka, Abbvie, Neetu Sangari, Pfizer, Jeremy Wildfire, Gilead, Khushboo Sharma, Accumulus & Bill Gibson, Accumulus 

Recording

12 April 

Emerging Trends & Innovation

RWD/RWE Programming & Reporting Standards: Utilising OMOP Standards

Berber Snoeijer, ClinLine, Mary Anne Rutkowski, Merck & Co, Jerry Wang, Janssen Research and Development & Mike Briganti, Janssen Research & Development

Recording

6 July

Real World Evidence

Designing Your RWD Study-Is Your Data Fit for Purpose?

Andy Richardson, Zenetar, Elizabeth Merrall, Janssen Research and Development, Jonathan Assayag, Pfizer & Mary Anne Rutkowski, Merck & Co

Recording

5 October 

Real World Evidence

Experiences with Adapting RWD to CDISC Submission Standards

Lauren Green, Amgen, Jeff Abolafia, Pinnacle 21,  Christine Rossin & Pfizer, Sandra VanPelt Nguyen, Pfizer.

Recording