Gardarsdottir H, Wang SV, Perez-Gutthann S, Rodriguez-Watson CV, Klungel OH, Rivera DR. It takes a village: strategic global collaborations to advance RWE within ISPE. Presentation to be given at the 2022 ICPE Conference; August 26, 2022. Copenhagen, Denmark.

BACKGROUND: The ISPE RWE Task Force promotes the science of pharmacoepidemiology research through global knowledge exchange of scientific methods and standards, education, and policies related to the development, implementation, and interpretation of Real-World Evidence generated from Real-World Data.

OBJECTIVES: 1. Update the society on RWE Task Force achievements and encourage member involvement with future deliverables
2. Illustrate how the work of the RWE Task Force members is enriched through strategic collaborations with well established external organizations
3. Showcase how the RWE Task Force stepped up to meet challenges related to COVID-19 research through novel strategic collaborations

DESCRIPTION: Overview of the RWE Task Force deliverables and SMART goals will be presented. This will be followed by a panel who will briefly present various collaborations and discuss best practices for advancing collaborations that benefit and continue to establish ISPE as a key strategic leader in advancement of RWE.

ISPE Real World Evidence Task Force Overview, Helga Gardarsdottir, Associate professor, Utrecht University, Utrecht
An overview of the formation, deliverables, and products of the RWE Task Force will be presented.

1. ISPOR, Shirley Wang, Associate professor, Harvard Medical School, Boston This talk will provide an overview of ISPE-ISPOR collaborative efforts, including development of guidance and tools to improve reproducibility and transparency.

2. ENCePP, Susana Perez-Gutthann, co-chair Steering Group, RTI-HS Epidemiology, Barcelona. This talk will present the history and continuing collaborations in the area of developing methods and code on conduct, as well as multi data source collaborations in safety, and effectiveness.

3. ASPEN RWE, presenter pending, This talk will showcase collaborations in the Asian region.

4. Reagan Udall Foundation, Carla Rodriguez-Watson, Director of Research A collaboration with the FDA Foundation Reagan Udall Evidence Accelerator was formed due to externally emerging need to highlight appropriates use of pharmacoepidemiologic methods and RWD sources for COVID-19 pandemic studies.

5. COVID collaboration, Olaf Klungel, professor, past president of ISPE, Utrecht University, Utrecht
This talk will present the development of multiple new COVID-19 related initiatives and collaborations including pharmacoepidemiologists world-wide.

Lessons Learned for Collaboration and Outreach
Donna Rivera, Associate Director for Pharmacoepidemiology, U.S. FDA
An overview of the key takeaways and how collaborations have contributed to the future plans for the RWE Task Force will be presented. We will introduce and discuss the next version, including role and functions.

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