Versions Compared

Key

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


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


Upcoming

Previous Community Forums:

Date/ TimeWorking GroupTitleSpeakersRecordings

18 January

14:00–15:00 (GMT) 09:00–10:00 (EST)

Real World Evidence

RWD Quality Challenges – Different Perspectives

Register Now!


Dr Cheryl Grandinetti, FDA andKris Wenzel, MMS
Holdings

Previous Community Forums:

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

Date (2023)Working GroupTitle SpeakersRecordings18 January Emerging Trends & TechnologiesSubmitting Real-world Data

Parag Shiralkar, Sumptuous Data Sciences & 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 & Barbara Hendrickson, University of Chicago


Recording

21 February

Data TransparencyData Privacy and Data Sharing in Clinical Trials

Devaki Thavarajah, Instem & Deborah Collyar, Founder and President, PAIR

Recording

27 March

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 & Bill Gibson, Accumulus

Recording

12 April

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

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

Real World EvidenceDesigning 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

Recording

5 October 

Real World Evidence

Experiences with Adapting RWD into CDISC Submission Standards                                                                                                 

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

Recording