---

---

Day 1 Recording

• Passcode: w?pY3ZQt

Day 2 Recording

• Passcode: RZ.^a1@b

Location: Virtual

The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled “Fetal Pharmacology and Therapeutics” on October 21-22, 2021 to discuss the current state of fetal pharmacology and therapeutics and how it pertains to pediatric drug development.

Fetal pharmacology has made significant advances in recent years and has moved into the  clinical science space with considerations for both fetal therapeutics allowing in-utero treatment of the fetus to avert postnatal disease as well as aversion of fetal toxicity from in-utero exposure to drugs following medications administered to the pregnant woman. This advance in knowledge requires addressing both the regulatory and scientific aspects of fetal pharmacology.

Workshop objectives:

1. Review general regulatory and ethical considerations for fetal pharmacology and therapeutics
2. Describe methods to assess clinical and nonclinical safety and efficacy assessments to support clinical trials of drugs in pregnancy and the fetus
3. Highlight advances and existing knowledge in fetal therapeutics
4. Discuss key aspects of maternal-fetal modeling and simulation

Meeting Information and Registration:

This workshop is open to the public and is intended for clinicians, academicians, drug developers, and regulators, with no cost to attend. However, registration is required. For registration information, including a preliminary agenda please visit the M-CERSI website. You may register for remote access using the registration link.
This virtual public workshop will be available to view via webcast, but pre-registration is still required. You will receive the link to access the live webinar several weeks prior to the meeting. You must log in with your username and password which you create when you register.

Questions:

If you have any additional questions about this workshop, please contact:

Gilbert Burckart, PharmD.
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-2065
Email [email protected]