Get access

Pregnancy exposure registries: Academic opportunities and industry responsibility

Authors

  • Diego F. Wyszynski

    Corresponding author
    1. Amgen Inc., Global Regulatory Affairs and Safety, One Amgen Center Drive, MS 17-1-A, Thousand Oaks, California 91320
    • Amgen Inc., Global Regulatory Affairs and Safety, One Amgen Center Dr., MS 17-1-A, Thousand Oaks, CA 91320
    Search for more papers by this author

  • The author is a salaried employee at Amgen Inc. and possesses stock and stock options in the company.

Abstract

Pregnancy exposure registries systematically evaluate pregnancies and outcomes exposed to a medicinal compound or device during the gestational period. Historically, such programs partner an academic institution with one or more pharmaceutical companies or are run solely by a pharmaceutical company. However, other examples abound. This article describes what a pregnancy exposure registry is, as well as selected methodological challenges they face, using real examples and applications. Birth Defects Research (Part A), 2009. © 2008 Wiley-Liss, Inc.

Ancillary