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12P : Real-World Evidence for Regulatory Decision-Making: Guidance, Methods, and Case Studies
Monday June 8, 2026 1:00pm - 4:00pm EDT
TBD
Component Type: Tutorial
CE: ACPE 2.75 Knowledge UAN: 0286-0000-26-501-L04-P; IACET 2.75

Pre-Registration required and is an additional fee. Already registered? Log in to DIA's My Account/My Events.

This Short Course will be offered virtually – Join from anywhere!

This short course on real-world evidence (RWE) in regulatory decision-making offers a comprehensive exploration of how RWE is transforming the regulatory landscape for drugs and biologics. The course begins with an overview of global regulatory trends, highlighting the increasing acceptance and integration of RWE alongside randomized controlled trials to inform approvals, label expansions, and clinical development planning. Participants will learn to identify and assess diverse sources of real-world data (RWD), applying practical frameworks to determine when data are “fit for purpose” for regulatory use. Through case studies and recent regulatory guidance, the course illustrates the evolution of RWE from safety evaluation to supporting efficacy, label extensions, and population bridging, underscoring the importance of methodological rigor and early engagement with regulators. The curriculum emphasizes structured approaches and frameworks, for designing transparent and valid real-world studies, including the use of external control arms. Participants will learn that RWE generation for regulatory decision-making requires thoughtful study design and use of transparent frameworks to ensure data fitness and validity. The course will be interactive with the use of polling questions and participants are encouraged to raise scenarios they encounter for open discussion.

Receive $50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.

Registered attendees for this virtual Short Course will receive access to the course recording for 2 full months post-course! This allows you to remain flexible with your schedule and not worry if you need to step out momentarily. Have a conflict with the dates of the course, but are interested in the content? Register anyway and you will receive access to the recording!

Speakers
avatar for Jaclyn Bosco

Jaclyn Bosco

Vice President & General Manager, Global Head of Epidemiology & Scientific Strat, IQVIA, United States
Dr. Jaclyn Bosco Global Head of Epidemiology & Scientific Strategy in Real World Evidence at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated... Read More →
avatar for Kourtney Davis

Kourtney Davis

Vice President, Global Epidemiology at Janssen R&D, LLC, The Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Dr. Kourtney Davis is currently Senior Director and Therapy Area Matrix Lead for Global Epidemiology at Janssen R&D, where she leads a team of 20+ epidemiologists aligned to therapy areas (CNS, Immunology, CV/Met, Oncology, ID/Global Public Health/Vaccines, and Pulmonary Hypertension... Read More →
avatar for Linda Kalilani

Linda Kalilani

Executive Director and Head of Oncology Epidemiology, GSK, United States
Linda Kalilani is an Executive Director & Head of Oncology Epidemiology at GlaxoSmithKline. She has worked as an epidemiologist in the pharmaceutical industry for over 10 years. She has led the development of cross-functional real-world evidence strategies, has extensive experience... Read More →
avatar for Isha Riley

Isha Riley

Associate Director, Pharmacoepidemiololgy & Risk Management Implementation, Regeneron, United States
Isha Mehta Riley is an Associate Director of Pharmacoepidemiology and Risk Management at Regeneron Pharmaceuticals. She has extensive experience in post-authorization safety strategies, including real-world evidence generation and risk management activities to inform global regulatory... Read More →
Monday June 8, 2026 1:00pm - 4:00pm EDT
TBD The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  07: RegCMC-Product Quality, Tutorial |   10: Stats-EvidenceGeneration-RWE, Tutorial |   17: Short-Courses, Tutorial
  • format csv
  • Credit Type ACPE, IACET
  • Tags Tutorial

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