Scientific and Ethical Considerations for Inclusion of Pregnant Women in Clinical Trials

Course Description

The inclusion of pregnant women in clinical trials has long been a complex balance between providing for the health of the mother and potential risks to the fetus. Current labeling information on drug products is typically based on nonclinical data with (or without) limited human safety data for use in pregnancy. The lack of information based on clinical data often leaves the health care provider and the patient reluctant to treat an underlying condition, which in some cases may result in more harm to the woman and the fetus than if she had been treated. This web seminar will discuss the scientific and ethical issues that should be addressed when considering the inclusion of pregnant women in drug development clinical trials.

Learning Objectives

• Discuss the scope of the draft guidance released by the FDA in April 2018
• Review regulations that govern the conduct and oversight of research in the pregnant population
• Examine reasons for considering inclusion of pregnant women in clinical trials in pre- and post-market studies
• Evaluate key differences between the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) regulations as they pertain to pregnant women
• Discuss minimal versus research-related risks
• List additional resources for general trial design and statistical analysis

Who Should Attend

• Medical Affairs and Development Professionals
• Project Managers
• Clinical Investigators
• Regulatory Affairs Professionals
• Academic Medical Center and Research Institution staff supporting clinical research
• Personnel responsible for ensuring compliance with Good Clinical Practice (GCP) regulations

Instructor

Elizabeth Ronk Nelson, M.P.H.

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-22-015-L04-P. Released: 5/22. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.