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The Community Forum creates a space for the PHUSE Community to unite and discuss industry topics of interest in an informal setting. Alongside this, each Working Group will use Disqus to host offline discussions and continue sharing information. This event is free and takes place virtually. If you have any questions, contact workinggroups@phuse.global.

To catch up on the previous Community Forums, visit the PHUSE Community Forum Archivearchive


Previous Community

Forum

Forums:

Click on links below for more information to view the recordings.

Date/ TimeWorking Group
Title 
TitleSpeakersRecordings

18 January

Emerging Trends & Technologies

Submitting
Real
-world Data

Parag Shiralkar (Sumptuous Data Sciences) and Jeff Abolafia (Pinnacle 21)

Recording

16 FebruarySafety AnalyticsReimagining a Safety Submission – Aggregate Safety Assessment Planning

Greg Ball (ASAPprocess), Mary Nilsson (Eli Lilly), Mac Gordon (Janssen Research & Development) and

Barbara Hendrickson (University of Chicago)
World Evidence

RWD Quality Challenges – Different Perspectives


Dr Cheryl Grandinetti, FDA andKris Wenzel, MMS


Recording

21 February

Data TransparencyData Privacy and Data Sharing in Clinical Trials

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

Recording

27 MarchSafety AnalyticsReimagining 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) and Bill Gibson, (Accumulus)

Recording

12 AprilEmerging Trends & TechnologiesRWD/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 JulyReal World EvidenceDesigning Your RWD Study: Is Your Data Fit for Purpose?

Andy Richardson (Zenetar), Elizabeth Merrall (Janssen Research and Development), Jonathan Assayag (Pfizer)

and Mary Anne Rutkowski (Merck)

Recording

5 October 
Real World Evidence

Experiences with Adapting RWD into CDISC Submission Standards                                                                                                                                      

                                                                                                       

Risk Based Quality Management

The Risk Based Monitoring Feedback Loop

Vera Pomerantseva, ZS Associates


Recording

17 April


Emerging Trends & Technologies

Dr. Junshui Ma, Merck

Recording

18 April 

Real World Evidence

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

Lauren Green (Amgen), Jeffrey Abolafia (Pinnacle 21) Christine Rossin (Pfizer) and Sandra VanPelt Nguyen (Pfizer)

Recording