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Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation: A 3-Part Virtual Public Workshop

Monday, May 9, 2022, 10:00 a.m. - 2:30 p.m. ET
Location
Zoom
Past Event

Event Recording

Session #1: Understanding the impact of data gaps for medication use during pregnancy and lactation
10:00 - 11:25 AM ET
View a recording of this webinar:  [recording link to be added here after the event]

Session #2: Regulatory perspective on the collection and use of real-world data to evaluate medications during pregnancy and lactation
11:25 - 12:20 PM ET
View a recording of this webinar:  [recording link to be added here after the event]

Session #3: Novel application of real-world data to evaluate medication use in pregnancy and lactation
1:00 - 2:30 PM ET
View a recording of this webinar:  [recording link to be added here after the event]

Hosted by Johns Hopkins Center of Excellence in Regulatory Science and Innovation (JH-CERSI) and the Food and Drug Administration Office of Women's Health

Overview

OWH Graphic

Many chronic and/or pregnancy-related health conditions require the use of medication during pregnancy and lactation. However, few clinical trials enroll pregnant or lactating participants, thus, there is a lack of data on medication safety and efficacy in this population. Through a 3-session virtual workshop, we will highlight the potential role of real-world data to help address these gaps in our knowledge, the opportunities and challenges of collecting real-world data, and current regulatory perspectives on the collection and potential use of real-world data.

 

Agenda & Speakers

 

 

KaveetaVasisht

Kaveeta Vasisht, MD, PharmD

Opening Remarks
Associate Commissioner for Women's Health
Director, Office of Women's Health
Food and Drug Administration

 

 

 

XiaobinWang

Xiaobin Wang, MD, ScD, MPH

Host
Johns Hopkins University

Session #1: Understanding the impact of data gaps for medication use during pregnancy and lactation

This 90-minute session will present patient and clinician perspectives on the challenges of navigating mediation use with the current lack of clinical trial data in pregnant and lactating people. The speakers will discuss recent findings related to behaviors and attitudes towards medication use in during pregnancy and present real-world data on national trends in medication use before, during, and after pregnancy.

Catherine Sewell

Catherine Sewell, MD, MPH

Moderator
Food and Drug Administration

Kristin Darwin

Kristin Darwin, MD

Speaker #1
Johns Hopkins University
IrinaBurd

Irina Burd, MD, PhD

Speaker #2
Johns Hopkins University
Sara Head

Sara Head, PhD, MPH

Speaker #3
Food and Drug Administration
Chris Ladd Acosta

Christine Ladd-Acosta, PhD

Speaker #4
Johns Hopkins University

Session #2: Regulatory perspective on the collection and use of real-world data to evaluate medications during pregnancy and lactation

This 60-minute session will focus on regulatory perspectives on the collection and use of real-world data to help understand the potential risks and benefits of medicines in people who are pregnant or lactating.

Susan Matcha

Susan Bersoff-Matcha, MD

Moderator
Food and Drug Administration
Ken Quinto

LCDR Kenneth Quinto, MD, MPH

Speaker #1
Food and Drug Administration
Leyla Sahin, MD

Leyla Sahin, MD

Speaker #2
Food and Drug Administration
Kira Leishear

Kira Leishear, PhD, MS

Speaker #3
Food and Drug Administration
Danijela Stojanovic

LCDR Danijela Stojanovic, PharmD, PhD

Speaker #3
Food and Drug Administration

Session #3: Novel application of real-world data to evaluate medication use in pregnancy and lactation

This 90-minute session will discuss innovative ways to collect real-world data to inform medication use, safety and effectiveness during pregnancy and lactation.

AhizechukwuEke

Ahizechukwu Eke, MBChB, PhD, MPH

Moderator
Johns Hopkins University
Mili Duggal

Mili Duggal, PhD

Speaker #1
Food and Drug Administration
Sonia Hernandez

Sonia Hernandez-Diaz, MD, DrPH

Speaker #2
Harvard University
Teresa Baker

Teresa Baker, MD

Speaker #3
Texas Tech University Health Sciences Center
Tina Chambers

Tina Chambers, PhD, MPH

Speaker #4
University of California at San Diego

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005942-06 with 100 percent funded by FDA/HHS.  The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

Work presented by Christine Ladd-Acosta, PhD, Johns Hopkins University is funded by 3U01FD005942-04S1 through the FDA Office of Women's Health.

Contact

For questions and concerns, please email Jill Curran at jcurra14@jhmi.edu.