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Tuesday, June 21 • 11:00am - 12:00pm
#219: Post-Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-554-L04-P ; CME 1.00; RN 1.00

Historically, regulators have required sponsors to collect pregnancy safety information in the post-marketing setting through prospective registries. However, pregnancy registries have practical barriers to enrolling subjects and often suffer from the lack of an adequate control group, inadequate power to achieve study objectives, high operational cost, a lack of generalizability, and long timelines before results are available to support clinical decisions. There is increasing opportunity and ability for real-world data and real-world evidence (RWD/E) from claims and electronic health record (EHR) databases to address some of the challenges seen with registries and more efficiently answer the question of drug safety during pregnancy. Retrospective database studies allow for observation of patients representing a broad population – not just those self-selected for registry enrollment or referred by providers, and the larger sample size enables faster accumulation of data and ultimately insight into patient safety. This session will discuss various fit-for-purpose pregnancy study options to inform a future framework that includes prospective registries, retrospective database studies, single-arm safety studies or enhanced pharmacovigilance with criteria dependent on the patient population in scope. In addition, the recent EMA guideline on good pharmacovigilance practices for pregnancy prevention programs will be discussed.

Learning Objectives

Discuss fit-for-purpose pregnancy safety study options including prospective registries, real-world data retrospective database studies, single-arm safety studies, enhanced pharmacovigilance or a combination of studies to inform a future framework for pregnancy safety studies; Describe industry, FDA, and EMA current thinking of various study types, criteria, and requirements for post-approval pregnancy safety studies.


Chelsea O'Connell, MS, RAC


FDA Perspective: Postapproval Safety Studies in Pregnant Individuals
Leyla Sahin, MD

Assessing Need and Effectiveness of Pregnancy Prevention Programs: A Crucial Piece of the Jigsaw
Priya Bahri, PhD, RPh

Fit-for-Purpose Pregnancy Safety Study Designs: Considerations for Developing a Framework
Rohini Hernandez, PhD, MPH

Barriers and Future Considerations to Generating Meaningful Safety Data from Post-Approval Safety Studies in Pregnancy
Lockwood Taylor, PhD, MPH

avatar for Priya Bahri

Priya Bahri

Lead Pharmacovigilance and Risk Management Guidance and Policy, European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
avatar for Rohini Hernandez

Rohini Hernandez

Director, Center for Observational Research, Amgen, United States
Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior... Read More →

Leyla Sahin

Acting Deputy Director for Safety, DPMH, OND, CDER, FDA, United States
Dr. Sahin is an ob/gyn who is the Acting Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs in CDER. She has led various maternal health related scientific and regulatory/policy initiatives. She was a working group member on the... Read More →
avatar for Lockwood Taylor

Lockwood Taylor

Senior Principal, Real-World Strategy and Innovation, IQVIA, United States
Dr. Lockwood Taylor is a Senior Principal on the Real World Strategy and Innovation team at IQVIA. An epidemiologist by training with specific expertise in RWE for regulatory submissions, signal detection and evaluation, and post-approval safety studies in pregnancy, Lock has 15... Read More →

Tuesday June 21, 2022 11:00am - 12:00pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Forum