What do you need to know about aggregate reporting?

Role of Aggregate Reporting in Pharmacovigilance

Aggregate reporting is a key component of post-marketing surveillance, designed to systematically collect and analyze safety data related to adverse drug reactions (ADRs). These reports are submitted to regulatory authorities and involve a detailed assessment of the drug’s benefit-risk profile, with patient safety as the top priority.

Types of Aggregate Reports

Aggregate reporting services offer comprehensive analysis of global safety data for a product, helping stakeholders understand its evolving safety profile and monitor its benefit-risk ratio over time. The type of aggregate report required depends on the product’s stage in the lifecycle—whether it is in clinical development or on the market. Common types of aggregate safety reports include:

• Clinical Study Reports (CSR)
• Development Safety Update Reports (DSUR)
• Periodic Safety Update Reports (PSUR) / Periodic Benefit-Risk Evaluation Reports (PBRER)
• Periodic Adverse Drug Experience Reports (PADER)

Different regulatory authorities require different types of reports. For instance, the U.S. FDA mandates PADERs, while PSURs or PBRERs are required in the EU, Canada, and Japan. Each of these reports has specific requirements and serves a unique role in the broader pharmacovigilance framework.

Challenges in Aggregate Reporting and DDReg’s Solutions

Aggregate reporting faces several challenges, including:

• Ensuring compliance with regulatory submission timelines
• Managing large volumes of data prone to manual errors
• Tracking the lifecycle of a report from drafting to submission
• Maintaining consistency across updates and subsequent reports
• Adapting to frequently changing regulatory guidelines
• Shortage of skilled resources and cross-functional coordination

As the regulatory environment grows increasingly complex, the demand for specialized expertise, strong project management, and technological support becomes more critical.

How DDReg Supports Aggregate Reporting

The medical and safety experts at DDReg bring decades of experience in preparing high-quality aggregate safety reports for over 130 countries. Their services include:

• Developing and maintaining reporting calendars and submission schedules using proprietary tools
• Generating line listings and tabulations
• Conducting thorough medical reviews
• Managing regulatory submissions and responding to agency queries

With a strong focus on regulatory compliance and efficiency, DDReg leverages automation and digital tools to streamline workflows, reduce manual errors, and ensure reports meet the latest regulatory standards and deadlines.

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