Pregnancy safety studies are essential for meeting regulatory requirements to assess the safety of medications and vaccines during pregnancy. However, designing and conducting these studies presents challenges such as small sample sizes, long follow-up periods, inadequate recruitment and retention and delayed timelines. Addressing these obstacles requires specialized knowledge, experience and tailored solutions.
Join this informative webinar to gain insights from leading pregnancy and lactation study experts who will discuss innovative and comprehensive approaches to optimize the design and execution of pregnancy safety studies. Attendees will learn practical strategies and specialized solutions to conduct these studies more efficiently and with the quality and rigor needed for regulatory acceptance.
Key topics covered:
- Understand the Regulatory Landscape: Learn how to navigate and respond to regulatory commitments, understand current trends and gain insight into the evolving FDA and EMA regulatory landscape, including strategies for complementary (prospective + retrospective) study delivery.
- Optimize Study Designs: Examine the advantages of various pregnancy safety study designs, improve multi-sponsor collaborations and leverage real-world data to develop an optimal approach:
- Pregnancy exposure registries (single and multi-product)
- Descriptive pregnancy safety studies
- Healthcare database pregnancy studies (using existing data)
- Innovative Recruitment and Retention Solutions: Explore effective global recruitment strategies, practical operational approaches and the use of digital technologies to reduce burden, streamline data collection and improve participant retention.
Register now to gain valuable insights and discover innovative strategies to optimize pregnancy safety studies.
Speakers
Barbara Hawkins, Vice President, Global Head, PPD Observational Studies, Thermo Fisher Scientific
Barbara is a highly seasoned senior leader who provides strategic vision and direction to ensure proper study conduct and operational excellence across a global portfolio. Her focus on enhancing systems and processes fosters an effective working environment across departments, ensuring the highest quality deliverables to meet client expectations. Barbara’s strategic and collaborative approach not only optimizes client relationships but also drives innovation excellence. With more than 35 years of experience in the pharmaceutical industry, she has held positions in both operations and commercial strategy, spanning all phases of drug development.
Message Presenter
Diego Wyszynski, MD, MHS, PhD, Vice President, PPD CorEvitas Pregnancy Registries, Thermo Fisher Scientific
Dr. Diego Wyszynski is a distinguished clinician and perinatal pharmacoepidemiologist specializing in drug safety evaluation using non-randomized data, particularly in pregnancy and early infancy. He has led numerous international pregnancy exposure registries and descriptive pregnancy safety studies.
Dr. Wyszynski has authored over 100 peer-reviewed publications and edited three textbooks on birth defects. He founded Pregistry, a company focused on pregnancy research and registries, which was acquired by CorEvitas and later by Thermo Fisher Scientific. Earlier in his career, he served as Associate Professor of Medicine and Epidemiology at Boston University and worked in drug safety for more than 20 biopharma and biotech companies.
He is editor of Birth Defects Research, the official journal of the Society for Birth Defects Research and Prevention, and a member of the Society’s Publications Committee. He also participates in the Medications in Pregnancy and Lactation Special Interest Group of the International Society for Pharmacoepidemiology.
Message Presenter
Syd Phillips, MPH, Senior Research Scientist, Epidemiology and Scientific Affairs, PPD Observational Studies, Thermo Fisher Scientific
Syd Phillips, MPH, is a researcher with more than 17 years of experience in pharmacoepidemiology, drug utilization and safety studies (including pregnancy studies), real-world evidence and regulatory strategy/decision-making in industry settings. She is a founding member of the IQVIA US Epidemiology and Drug Safety team, where she was responsible for single/multi-year studies, single/multi-country projects and multi-vendor collaborations for post-marketing activities across a wide variety of therapeutic areas. Most recently, she led the US RWE Safety and Epidemiology team for Lumanity.
Ms. Phillips is an active member of the International Society for Pharmacoepidemiology (ISPE) where she served on the Development Committee (Chair 2015 – 2016), the Scientific Program Committee (Chair 2021), Asian Conference on Pharmacoepidemiology (ACPE) Steering Committee and is a founding member of the of the Health Equity and Diversity Special Interest Group. She received her undergraduate and graduate degrees (Master of Public Health [MPH]) from the University of Michigan.
Message PresenterWho Should Attend?
- Pharmaceutical and biotech professionals
- Pharmacovigilance/drug safety scientists
- Clinical Development/clinical researchers
- Regulatory Affairs
- Medical Affairs
- Real-World Evidence (RWE) professionals
- Epidemiologists
- Obstetricians
- Maternal-fetal medicine specialists
- Pediatricians
- Public health experts
- Policy makers
- Patient advocacy organizations
What You Will Learn
Attendees will:
- Learn how to navigate regulatory commitments, track trends and address evolving FDA and EMA requirements, including strategies for complementary (prospective and retrospective) study delivery
- Explore pregnancy safety study designs, enhance multi-sponsor collaboration and apply real-world data for better outcomes
- Discover global recruitment strategies, operational solutions and digital tools to ease burden and boost participant retention
Xtalks Partner
The PPD clinical research business of Thermo Fisher Scientific Inc.
The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, enables customers to accelerate innovation and increase drug development productivity. Utilizing patient-centered strategies and data analytics, their capabilities cover multiple therapeutic areas and include early development, all phases of clinical development, peri- and post-approval, novel approaches to patient recruitment and investigator sites, and comprehensive laboratory services. Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, they serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, they apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.
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