FDA/CDER – HESI Immunomodulators and Pregnancy Risk Assessment Workshop

FDA/CDER - HESI Immunomodulators and Pregnancy Risk Assessment Workshop
Silver Spring, MD, USA
February 11, 2020
US Food and Drug Administration

FDA CDER Immunomodulators and Pregnancy Workshop


The goal of this workshop is to convene key stakeholders to discuss both current and novel methodologies in preclinical and translational safety assessment of pregnancy risk associated with immunomodulatory therapy. Through the sharing of case examples, followed by a longer in-depth discussion within each session, the goal is to begin to address gaps in biology, current tools, and other aspects of pregnancy risk that need to be considered during drug development.


The  workshop is intended to provide an interdisciplinary forum for industry, academia and regulatory scientists to discuss:

  1. The current state of reproductive immunology
  2. How adequate are the current set of tools/methodologies to address pregnancy risk under immunomodulatory therapies
  3. What additional tools/methods are currently being developed that could address gaps
  4. Global regulatory considerations across various immunomodulatory modalities


Requirements: To gain building access, you must bring acceptable and valid government issued identification (ID).


Registration: Up-to-date information and registration can be found here. Registration will close on February 5, 2020. Due to the format and structure of this workshop, attendance is restricted to in-person attendees only.