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Virtual

Jan 24, 2022 8:00 AM - Jan 26, 2022 5:00 PM

DIA Global Pharmacovigilance and Risk Management Strategies Conference

Global Pharmacovigilance and Risk Management Strategies Conference is now fully virtual. Join us from the comfort of your own space!

Session 10: Post Approval Safety Studies: Approaches to Assessing Medication Exposure and Potential Safety Risks During Pregnancy

Session Chair(s)

Annette  Stemhagen, DrPH, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer

UBC, United States

Chelsea  O'Connell, MS, RAC

Chelsea O'Connell, MS, RAC

Director, Global Regulatory Policy & Intelligence

Amgen, United States

Historically, regulators have required sponsors to collect pregnancy safety information in the post-marketing setting through prospective registries. However, pregnancy registries have practical barriers to enrolling subjects and often suffer from the lack of an adequate control group, inadequate power to achieve study objectives, high operational cost, a lack of generalizability, and long timelines before results are available to support clinical decisions.

There is increasing opportunity and ability for real-world data and real-world evidence (RWD/E) from claims and electronic health record (EHR) databases to address some of the challenges seen with registries and more efficiently answer the question of drug safety during pregnancy. Retrospective database studies allow for observation of patients representing a broad population – not just those self-selected for registry enrollment or referred by providers, and the larger sample size enables faster accumulation of data and ultimately insight into patient safety.

This session will discuss various fit-for-purpose pregnancy study options to inform a framework that includes prospective registries, retrospective database studies, and single-arm safety/enhanced pharmacovigilance studies with criteria dependent on the patient population in scope.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize challenges that occur in prospective pregnancy registries
  • Describe opportunities that retrospective database studies bring to understanding drug safety during pregnancy
  • Assess a future framework of fit-for-purpose pregnancy study options in the postapproval phase

Speaker(s)

Leyla  Sahin, MD

Speaker

Leyla Sahin, MD

FDA, United States

Deputy Director for Safety, DPMH, OND, CDER

Carrie  Nielson, PhD, MPH

Speaker

Carrie Nielson, PhD, MPH

Amgen, United States

Observational Research Senior Manager

Carla  Jonker, MS

Speaker

Carla Jonker, MS

Medicines Evaluation Board (MEB), Netherlands

Senior Regulatory Project Leader

Krista F. Huybrechts, PhD, MS, FISPE

Global Challenges and Opportunities in Evaluating Peri-pregnancy Exposure and Safety Risks Through Database Studies

Krista F. Huybrechts, PhD, MS, FISPE

Harvard Medical School, United States

Associate Professor of Medicine and Epidemiology

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