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Monday, June 19 • 11:00am - 12:15pm
#117: Postmarketing Safety Studies: Approaches and Regulatory Insights

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-533-L04-P; CME 1.25; IACET 1.25; RN 1.25

We are seeing an increase globally in the number of postmarketing safety studies requested by regulatory agencies. This session will discuss approaches to planning and conducting observational postmarketing studies, regulatory perspectives on such studies and a case example.

Learning Objectives

Discuss approaches to postmarketing safety studies and the ways in which they can have impact and provide value.


Elsie Grace, PhD, MS


Take-Home Learnings on Do’s and Dont’s on the Planning and Conduct of a PASS
Javier Cid, DrPH, MD, MBA, MSc

How to Maximize the Impact of Postmarketing Research: Considerations for Effective Execution and Compliance
Aarthi B. Iyer, JD, MPH

An Innovative Patient-Centric Approach to Conducting Postmarketing Safety Studies
Deborah Covington, DrPH


Elsie Grace

Epidemiologist, Global Patient Safety, Eli Lilly and Company
Elsie Grace is a Senior Research Scientist at Eli Lilly and Company. Her work as a pharmacoepidemiologist within the Global Patient Safety organization focuses on providing epidemiologic expertise to the development, submission, and launch of products within the autoimmune therapeutic... Read More →


Javier Cid

Research Scientist, Evidera
Javier Cid, MD, DrPH, is Research Scientist and Epidemiologist at Evidera. He has over 20 years of experience, across academia, pharma companies and consulting, mainly in pharmacoepidemiology and drug safety, especially in neurosciences, oncology, diabetes, chronic kidney disease... Read More →

Deborah Covington

Senior Research Scientist, Evidera
Deborah Covington, DrPH, is a senior research scientist at Evidera and part-time faculty at the University of North Carolina, Wilmington. She received her doctorate from the University of North Carolina, Chapel Hill and has 30+ years of epidemiological research experience focusing... Read More →
avatar for Aarthi Iyer

Aarthi Iyer

Managing Director, Advarra
Aarthi B. Iyer is a Senior Regulatory Attorney & Managing Director for Kinetiq, a consulting and technology division of Quorum Review IRB. Aarthi provides guidance and regulatory analysis on issues related to human subjects research including informed consent, privacy, data use, and... Read More →

Monday June 19, 2017 11:00am - 12:15pm CDT
S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session