In this free webinar, learn how pregnancy exposure registries are helping in assessing medication safety and thus enhance pregnancy safety studies. Attendees will learn about the historical context of single- vs multi-sponsor pregnancy exposure registries and the current landscape. The featured speakers will discuss methodological, scientific and operational best practices. They will share lessons learned from successful multi-sponsor pregnancy exposure registries. Attendees will gain insights into industry viewpoints on operational considerations and practical challenges in setting up and maintaining single-product and collaborative registries.
TORONTO, Sept. 19, 2024 /PRNewswire-PRWeb/ -- Pregnancy exposure registries remain an important study design in the assessment of medication safety when used during pregnancy. However, slow enrollment, low numbers of patients and long study duration are well-known limitations.
The US Food and Drug Administration (FDA)'s draft guidance on the conduct of post-approval pregnancy safety studies (May 2019) encourages pharmaceutical companies (sponsors) "to work together directly or through consortiums to develop or support multiproduct registries." Likewise, the European Medicines Agency (EMA) addresses pregnancy registries in their Guidelines on Good Pharmacovigilance Practices (Dec 2019) urging the creation of disease registries over "medicinal product-specific registries." While there is concrete regulatory interest in the development of collaborative multi-sponsor efforts, numerous challenges remain.
This webinar will examine the conduct of multi-product/multi-sponsor pregnancy registries from several key perspectives. The expert speakers will review scientific methods in the context of regulatory precedent, provide pharmaceutical industry perceptions of internal and external considerations, offer Physician/scientific advisory committee member perspective and identify best practices to overcome obstacles.
The expert speakers will cover:
- Historical context for pregnancy registries and current state of affairs with regard to regulatory considerations in light of revised guidances from FDA and EMA, including real-world data approaches and descriptive pregnancy safety studies, issues with timing of approvals and inter-agency coordination while highlighting missed opportunities for collaboration
- Industry viewpoints on operational considerations and practical challenges in setting up and maintaining single-product and collaborative registries
- Physician, professional society and scientific advisory committee member perspectives
- Examples of successful multi-sponsor collaborations and lessons learned
Register for this webinar today to understand how pregnancy exposure registries are helping in assessing medication safety and thus enhance pregnancy safety studies.
Join Jessica Albano, PhD, MPH, Vice President – Epidemiology & Analytics, Syneos Health; Sara Ephross, PhD, Senior Director - Epidemiology, Syneos Health; Dr. Sigal Kaplan, PhD, BPharm, Director, Pharmacoepidemiology Leader, Teva Pharmaceutical Industries Ltd; and Laura McKain, MD, FACOG, Board-certified Obstetrician and Gynecologist, for the live webinar on Monday, October 7, 2024, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Multi-sponsor Pregnancy Exposure Registries: Physician, Scientific Advisory and Industry Insights.
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, [email protected], https://xtalks.com
SOURCE Xtalks
Share this article