Pharmacovigilance & Drug Safety

December 9, 2024

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…

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October 10, 2024

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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August 16, 2024

Transforming Pharmacovigilance: Solutions to Solve Regulatory Challenges

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…

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June 20, 2024

DE&I and Drug Safety: Surprising Connections to Improve Patient Health

Diversity, Equity, and Inclusion (DE&I) and drug safety in clinical trials teams may not have established relationships within an organization. Yet, these two areas of focus have more similarities than one might think. In our next installment of our series on our Interpretation of Pharmacovigilance Guidances and Regulations Initiative (IGR PV), we are exploring this…

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December 5, 2023

Operationalizing Patient Safety: An Overview of TransCelerate’s Interpretation of PV Guidances & Regulations Initiative

For the second installment of our Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) Initiative blog series, we will take a deep dive into the initiative and its goals. Established in 2018, this initiative germinated when it became apparent that some of the regulations issued by global Health Authorities can be unclear and/or challenging for…

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August 21, 2023

Clinical Research’s Next Frontier: Medicines in Pregnancy & Breastfeeding

This is the first post in an ongoing blog series about TransCelerate’s efforts to help biopharma R&D organizations navigate global regulations and improve safety for medications prescribed to pregnant and breastfeeding individuals. Future topics in this series will include tips on cultural shifts within an organization, patient experience in clinical trials, and future TransCelerate projects,…

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March 25, 2021

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practice

Intelligent automation of pharmacovigilance (PV) tasks holds significant potential to automate manual work associated with the processing and evaluation of reported adverse reactions, thereby facilitating higher quality and more efficient risk mitigation. However, while these technologies provide great hope for vastly improving pharmacovigilance processes for both sponsors and patients, existing ways of validating technology will…

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