Aug 18
The WS Overview Deck aims at providing readers with an understanding of why the RBM initiative was initiated, the problem it aims to solve, available tools and materials to facilitate operational implementation and the value realized by member companies since inception.
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A New Era in Advancing Care for Pregnant and Breastfeeding Patients
One major challenge facing the clinical research ecosystem is not whether, but how to study drug safety and efficacy in pregnant and breastfeeding populations. A growing number of organizations—including the ICH E21 Expert Working Group (EWG) and TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative—are diligently seeking ethical and responsible solutions to protect these…
Improving Medicine Use During Pregnancy & Breastfeeding: Forging a Path Forward
The scientific community intended to protect pregnant and breastfeeding populations when it strictly limited their involvement in clinical trials after the thalidomide crisis of the 1950s-1960s. Yet over the past few decades, people have increasingly recognized the real-life challenges posed by the lack of research into the safety of medications used during pregnancy and breastfeeding.…
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Patient safety depends partly on sponsor organizations’ compliance with pharmacovigilance (PV) regulatory requirements—even when global variations exist. Helping sponsors interpret and operationalize challenging PV regulations and guidances is the goal of TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative. In this third installment of our IGR PV blog series, we will examine the solutions…