SW-1C - Consolidated Multi-product/Disease-based Pregnancy Exposure Registries: How to Encourage Collaboration in a Fragmented Environment?

Background: 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 The FDA’s draft guidance on the conduct of post-approval pregnancy safety studies (May 2019) encourages pharmaceutical companies (sponsors), “to work together directly or through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 consolidated multi-sponsor efforts, numerous challenges remain.

Objectives: This symposium will bring together global views from several key perspectives on the conduct of multi-product/multi-sponsor pregnancy registries. We will review scientific methods, present regulatory perspectives on collaborative approaches, provide pharmaceutical industry perceptions of internal and external considerations and identify best practices to overcome obstacles. This symposium will benefit researchers, regulators and drug manufacturers wanting to better understand the benefits, opportunities and mechanics of initiating such an endeavor.

Description: Sara Ephross (moderator - 10 min) will provide an introduction of the symposium and will provide a brief background on the historical context for pregnancy registries and current state of the affairs with regard to regulatory considerations, issues with timing of approvals, and inter-agency coordination while highlighting missed opportunities for collaboration.

Leyla Sahin (panel - 15 min) will present regulatory agency view(s) from FDA perspective towards encouraging collaborations and limitations of current legislation.

Corinne de Vries (panel - 15min) will present regulatory agency view(s) from EMA perspective towards encouraging collaborations and limitations of current legislation.

Sigal Kaplan (panel - 15 min) will present industry viewpoints on operational considerations and practical challenges in setting up and maintaining collaborative registries.

Jessica Albano (panel - 15min) will present example(s) of successful multi-sponsor collaborations and lessons learned.

This symposium will conclude with a moderated interactive dialogue with the panel and audience engagement to discuss the current atmosphere, identified challenges and potential solutions that may increase the willingness and ability to initiate future multi-product/multi-sponsor collaborations (20 min).