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Aggregate Safety Reports Services in Pharmacovigilance

Detailed analysis of the benefit-risk evaluation for a pharmaceutical product cannot be conducted at the level of ICSR submission. Periodic safety reports review is important to determine the benefit-risk profile of a pharmaceutical product. These reports consist of detailed overview of data that the MAH has accumulated during consistent and critical monitoring of the product’s benefit-risk profile and adhere to ICH guidelines. Safety regulations and guidelines are ever evolving under aegis of stringent regulatory agencies like U.S. FDA and EMA. Thus, preparing aggregate reports & periodic safety update reports require vigilant & diligent review of periodic data on ADRs and SAEs. The regulatory requirements for report submission frequency are different for each region. It is important to maintain constancy when submitting crucial safety data to avoid duplication of effort. Organizations face many challenges during the development of Pharmacovigilance Aggregate reporting. Due to the wide range of documents involved, the process can be labour intensive and daunting. Additionally, high volumes of data bring high risks of error that could lead to non-compliance.

DDReg offers high-quality Pharmacovigilance Aggregate reporting and addendums as per ICH/EMA/U.S. FDA requirements & templates. From pre-submission to post-marketing reports, our dedicated team of life science experts work in initial research, information collation, authoring, compilation, preparation of individual case study report and submission to respective regulatory authorities and regulators across the globe. Our in-house tools and database allow efficient management and tracking of reports and mitigate potential errors.

DDReg’s Aggregate Report Expertise includes authoring, compilation, quality review and submission of :

  • Periodic Benefit-Risk Evaluation Report (PBRERs)
  • Periodic Safety Update Report (PSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • Annual Safety Reports (ASRs)

Basics of Pharmacovigilance Aggregate Reports and their essential role in drug safety

The safety of pharmaceutical products is critical for pharmacovigilance, and it’s foundation lies in the development and submission of pharmacovigilance aggregate reports. These reports, also commonly referred to as periodic safety reports, are pivotal in Literature Monitoring and assessing the safety profile of pharmaceutical products throughout their lifecycle Management.

Pharmacovigilance Aggregate Reporting involves the compilation and analysis of safety data from various sources, including individual case study reports. These reports communicate a comprehensive overview of the safety profile of a drug and provide valuable insight into potential risks and benefits that are associated with the drug’s use. Indeed, periodic safety reports are a key part of pharmacovigilance aggregate reporting and are submitted at regulatory intervals to regulatory authorities around the world. These reports are key in demonstrating a pharmaceutical organization’s commitment ongoing safety monitoring. They include a range of reports including but not limited to Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs)

Basics of Pharmacovigilance Aggregate Reports and their essential role in drug safety

Periodic Safety Update Reports (PSURs) are a comprehensive document that provide a detailed analysis of the global safety information regarding a pharmaceutical product. PSURs are typically submitted annually or quarterly depending on the competent authority’s requirements. PSURs consolidate safety information from various sources, including but not limited to clinical trials and post-market surveillance. They offer a more holistic view of the product’s safety profile.

A Periodic Adverse Drug Experience Report (PADER) is a requirement of the US FDA and it focusses on the adverse drug experiences reported for a particular pharmaceutical product during a defined reporting period. These reports are structured in a way that systematically present & communicates the most recent safety information, contributing to a comprehensive understanding of the drug’s safety profile over time.

Although individual case study reports provide detailed information about certain adverse events, pharmacovigilance aggregate reports offer a much broader and holistic perspective on safety. They allow trends & patterns to be identified, and potential signals which may not be noticed during the evaluation of individual cases in isolation.

Meticulous attention is given to data quality, consistency, and accuracy when preparing pharmacovigilance aggregate reports. Rigorous analysis is conducted to evaluate the overall safety of the drug and to identify any emerging safety concerns. The insights that are derived from these aggregate reports are incorporated into informed regulatory services decisions, updates in product labels, and risk mitigation strategies.

Pharmacovigilance aggregate reporting goes beyond regulatory compliance as it is also a proactive measure taken by stakeholders which contributes to public health. This is because it ensures the benefits of a drug continue to outweigh the risks associated with it. DDReg’s pharmacovigilance aggregate reporting services are pivotal in support global pharmaceutical companies in fulfilling their regulatory & compliance obligations and maintaining the highest standards of drug safety.

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