Multi-sponsor Pregnancy Exposure Registries: Physician, Scientific Advisory and Industry Insights

This webinar will examine the conduct of multi-product/multi-sponsor pregnancy registries from several key perspectives.

October 7, 2024

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 The FDA’s draft guidance on the conduct of post-approval pregnancy safety studies (May 2019) encourages pharmaceutical companies (sponsors), “to work together directly or through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 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. We 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.

Presenters 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 RWD 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

This webinar will provide:

Historical context of single- vs multi-sponsor pregnancy exposure registries and current landscape
Methodological, scientific and operational best-practices
Lessons learned from successful multi-sponsor pregnancy exposure registries
This webinar will benefit drug and biologics manufacturers wanting to better understand the benefits, opportunities and mechanics of initiating such an endeavor.