Using automation and templates to accelerate PBRER and DSUR generation Using Automation and Templates to Accelerate PBRER and DSUR Generation Pharmaceutical companies are tasked with maintaining patient safety and product efficacy through various regulatory frameworks, including the preparation of Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs). This article aims to provide a comprehensive step-by-step tutorial for global pharmacovigilance professionals on using automation and templates to enhance the generation of these reports. The guidance outlined herein is aligned with US FDA requirements, as well as relevant EU and UK standards. 1. Understanding PBRER and DSUR in Global…

Quality Checks, Consistency Controls, and Style Guides for PSUR Content Introduction to Periodic Safety Update Reports (PSUR) The Periodic Safety Update Report (PSUR) is an integral component of global pharmacovigilance obligations, particularly in the context of post-market surveillance. Both the FDA and EMA, as well as other global regulatory bodies, mandate that marketing authorization holders (MAHs) provide these reports at defined intervals. The PSUR informs regulatory authorities about the safety profile of a product throughout its lifecycle. This article delineates the step-by-step processes for quality checks, consistency controls, and style guides essential for effective PSUR content. Understanding PSUR Regulations To…

Outsourcing models for PSUR authoring and safety medical review Outsourcing models for PSUR authoring and safety medical review Post-Marketing Safety Update Reports (PSUR), Periodic Benefit-Risk Evaluation Reports (PBRER), and Development Safety Update Reports (DSUR) are critical components of global pharmacovigilance and periodic safety reporting. These documents help ensure that the safety profile of a medicinal product remains favorable throughout its lifecycle. For professionals in the pharmaceutical, clinical operations, and regulatory affairs sectors, understanding various outsourcing models for authoring these reports is crucial for compliance with the U.S. FDA, EMA, and other regulatory bodies. Understanding PSUR, PBRER, and DSUR in Global…

Future Outlook for Harmonised Periodic Safety Reporting Requirements The global pharmaceutical landscape is continuously evolving, necessitating greater harmonization in periodic safety reporting requirements such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). This comprehensive article aims to provide an in-depth tutorial on the current and future state of these safety reporting requirements, focusing on regulatory frameworks from the US, UK, and EU. The article is structured to support pharmaceutical professionals engaged in clinical operations, regulatory affairs, and medical affairs in navigating the complexities associated with global pharmacovigilance. Understanding Periodic Safety Reporting…

Periodic Safety Reporting for Biosimilars, Vaccines, and ATMP Portfolios The significance of safety monitoring in the pharmaceutical industry cannot be overstated, especially concerning Biosimilars, Vaccines, and Advanced Therapy Medicinal Products (ATMPs). Adhering to regulatory frameworks such as the PSUR (Periodic Safety Update Report), PBRER (Periodic Benefit-Risk Evaluation Report), and DSUR (Development Safety Update Report) is essential for maintaining global pharmacovigilance obligations. This article serves as a comprehensive tutorial aimed at guiding pharmaceutical professionals through the intricacies of periodic safety reporting, providing step-by-step instructions to achieve compliance with US and international regulations. Understanding the Regulatory Landscape for Safety Reporting Periodic safety…

Training safety writers and physicians on PBRER and DSUR best practices Training Safety Writers and Physicians on PBRER and DSUR Best Practices Introduction to PBRER and DSUR The Post-Authorization Safety Study (PASS) and Data Safety Update Reports (DSUR) are essential components of global pharmacovigilance. These reports serve to ensure that drugs on the market are monitored for safety and efficacy after authorization. Professionals in the pharmaceutical industry, including safety writers and physicians, must understand the requirements and best practices for generating these documents, particularly for the US market where the FDA has set specific guidelines. Periodic Safety Update Reports (PSUR)…

How inspectors review PSUR and PBRER content during PV inspections Understanding Inspector Review of PSUR and PBRER Content during Pharmacovigilance Inspections Introduction to Periodic Safety Reporting Pharmacovigilance (PV) serves as a critical element in ensuring the safety and efficacy of pharmaceutical products. Central to this framework are periodic safety update reports (PSURs) and periodic benefit-risk evaluation reports (PBRERs). These documents enable regulatory authorities to assess the safety profile and risk-benefit balance of marketed drugs over time. Regulatory expectations for PSURs and PBRERs span across various global jurisdictions, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA),…

KPIs and dashboards to monitor periodic report on time performance KPIs and Dashboards to Monitor Periodic Report On Time Performance In the evolving landscape of global pharmacovigilance, staying compliant with periodic safety reporting requirements is essential for pharmaceutical organizations. This article serves as a comprehensive guide for industry professionals to understand the Key Performance Indicators (KPIs) needed to monitor the on-time performance of periodic reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs). We will also discuss the utilization of dashboards for effective monitoring, ensuring that your organization maintains compliance…

Case Studies of REMS Programmes That Evolved After Safety Signals In an era rife with evolving safety signals, the application of Risk Evaluation and Mitigation Strategies (REMS) has become increasingly important for ensuring patient safety while allowing patients access to necessary medications. Implementing effective REMS programmes is an essential component of post-marketing commitments (PMCs), particularly within the regulatory frameworks set forth by the US Food and Drug Administration (FDA). This tutorial will provide a step-by-step analysis of case studies highlighting how REMS programmes have adapted following the emergence of safety signals. Furthermore, we will explore associated elements such as post-marketing…

Tracking and Fulfilling PMCs and PMRs to Avoid Regulatory Non-Compliance In the complex landscape of pharmaceutical regulation, ensuring compliance with post-marketing commitments (PMCs) and post-marketing requirements (PMRs) is paramount. These obligations arise as crucial components of risk evaluation and mitigation strategies (REMS) and are essential for the ongoing safety and efficacy assessment of marketed products. This tutorial serves as a comprehensive guide for pharmaceutical and clinical professionals in the US, UK, and EU to effectively track and fulfill these commitments while avoiding potential regulatory pitfalls. Understanding Post-Marketing Commitments (PMCs) and Post-Marketing Requirements (PMRs) Before diving into compliance strategies, it is…