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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 previous Community Forums, visit the PHUSE Community Forum Archive

Upcoming Community Forums:

Date/ TimeWorking GroupTitleSpeakers

18 January

14:00 BST / 09:00 EDT

Real World Evidence

RWD Quality Challenges – Different Perspectives

Registration will be open on December 4.

Dr Cheryl Grandinetti, (FDA) and Kris Wenzel (MMS Holdings)


Previous Community Forums:

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

Date/ TimeWorking GroupTitle SpeakersRecordings
18 January 2023Emerging Trends & TechnologiesSubmitting Real-world Data

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

Recording

16 February 2023Safety 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)

Recording

21 February

2023

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 March

2023

Safety 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 April

2023

Emerging 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 July

2023

Real 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 

2023

Real World Evidence

Experiences with Adapting RWD into CDISC Submission Standards                                                                                                                                      

                                                                                                       

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

Recording

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