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Xtalks, Online
2024-10-07
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The US Food and Drug Administration (FDA)’s draft guidance on the conduct of post-approval pregnancy safety studies (May 2019) encourages pharmaceutical companies (sponsors) “to work together directly or through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 (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
Register for this webinar today to understand how pregnancy exposure registries are helping in assessing medication safety and thus enhance pregnancy safety studies.
Keywords: Drug Development, Pregnancy, Clinical Research, Drug Safety, Patient Recruitment, Patient Safety, Registries , Clinical Data, Regulatory, Patient Registry, Safety Assessment, Clinical Data Registry
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Organized by:
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Xtalks |
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Invited Speakers:
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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
Laura McKain, MD, FACOG, Board-certified Obstetrician and Gynecologist
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Deadline for Abstracts:
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2024-10-07
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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