Pregnant participants in clinical trials, Upcoming Webinar Hosted by Xtalks
In this free webinar, learn about recent and ongoing efforts to increase the inclusion of pregnant and lactating individuals in clinical trials. Attendees will learn about new guidance under development, existing and proposed guidances. The featured speakers will discuss the FDA's PDUFA VII commitments to establish a framework for pregnancy safety studies.
TORONTO, Dec. 18, 2024 /PRNewswire-PRWeb/ -- Excluding pregnant and breastfeeding persons from clinical research has resulted in a significant deficiency of crucial dosing and safety data, leading to incomplete or non-existing information for healthcare professionals and patients at the time of drug approval. Women are entitled to explicit, evidence-based guidance to manage their diseases and chronic conditions during pregnancy and lactation, ensuring the best possible outcomes for both their health and that of their newborn.
Explanations on the ethical considerations supporting the inclusion of pregnant individuals in clinical research brought attention to the removal of the outdated classification of pregnant individuals as a vulnerable population. Several institutions and regulatory agencies have responded to recent developments with initiatives to enhance the participation of pregnant and lactating individuals in clinical studies.
This webinar will cover recent and ongoing efforts to increase the inclusion of pregnant and lactating individuals in clinical trials. The expert speakers will examine new guidance under development, existing and proposed guidances and the FDA's PDUFA VII commitments to establish a framework for pregnancy safety studies.
Register for this webinar to explore how the inclusion of pregnant and lactating individuals in clinical trials is transforming healthcare outcomes.
Join experts from ICON, Dr. Martine Dehlinger-Kremer, PhD, MS, Vice President of Scientific Affairs, Pediatric Subject Matter Expert, Centre for Pediatric Clinical Development, Drug Development Solutions; Dr. Mark Sorrentino, MD, MS, Vice President, Centre for Pediatric Clinical Development, Drug Development Solutions; Dr. Monica Lee, MD, Medical Director, Medical Affairs; and Ms. Heather Peterson, RN, BSN, Pediatric Strategy Liaison, Centre for Pediatric Clinical Development (CPCD), for the live webinar on Friday, January 17, 2025, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Pregnant participants in clinical trials.
ABOUT XTALKS
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars and digital content to the global life science, food, healthcare and medical device communities. Every year, thousands of industry practitioners (from pharmaceutical, biotechnology, food, healthcare and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps professionals stay current with industry developments, regulations and jobs. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit https://xtalks.com
For information about hosting a webinar visit https://xtalks.com/why-host-a-webinar/
Media Contact
Vera Kovacevic, Xtalks, +1 (416) 977-6555 x371, vkovacevic@xtalks.com, https://xtalks.com/
View original content to download multimedia:https://www.prweb.com/releases/pregnant-participants-in-clinical-trials-upcoming-webinar-hosted-by-xtalks-302334634.html
SOURCE Xtalks


Upcoming Life Sciences Events
- February 2025
- Biotechgate Digital Partnering February 2025
- Zurich: 18th Annual European Life Sciences CEO Forum
- March 2025
- Miami: Investival Showcase USA