Aggregate Reports in Pharmcovigilance
Taking emerging adverse events in its ambit, Aggregate reports (PSURs/PBRERs/DSURs) aim to provide a comprehensive and critical analysis of the risk benefit balance of the product. They periodically create the golden opportunity for an overall safety re-evaluation thus providing an insight into any investigations or any changes which need to be made to the product information. Several sources contribute to the formation of the aggregate reports viz. Spontaneous reports, observational studies, and data from clinical and non-clinical studies to mention a few. In light of the complexity of the document and the exacting and inflexible regulations, preparation of aggregate reports of the highest quality and timely submission is a major challenge globally.
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved. We now recognize the significance of a systematic approach to monitoring and improving the safe use of medicines. Aggregate reporting is the process that examines the collective safety information from a broad range of sources systematically and gives the conclusions to regulators worldwide.
The aggregate safety records are presented to regulators as soon as the medicine is marketed all-around and facilitates understanding of the product’s risk and benefit profile over time. These reports focus not on individual cases, but preferably on overview, assessment of the safety profile and benefit-risk-evaluation of Adverse Drug Reaction (ADR) and the Serious Adverse Event (SAE) and pregnancy reports.
Join the Aggregate Reporting Certification in Drug Safety and Pharmacovigilance and upgrade your skill set today.
Modules to be Covered
- Introduction to Aggregate Reports
- Extraction of NDA line listing from Argus Safety for preparation of PADERs
- Overview of PADERs and its preparation
- Extraction of ICH line listing from Argus Safety for preparation of PSURs
- Overview of PSURs and its preparation
- Literature Search and identification of Potential and Identified Risk
- Extraction of Case listing for Aggregate reporting purposes
- Live Online Sessions
- Hands-on Practical training on the Oracle Argus safety database.
Why Gratisol Labs ?
- Industry Endorsed Curriculum
- Access to Oracle Argus Safety database
- Live Online Sessions
At the end of this Program you will be able to learn:
- The procedure to generate line listings
- Summarize tabulation of ADR cases in Oracle Argus Safety Database
- Detailed discussion on
- Content and preparation of the reports
- Country specific requirements
- Guidelines governing periodic reports
Aggregate Safety Report Services and Expertise
Gratisol Labs Aggregate Safety Report services include planning, time management, data requests, writing, quality control, strategic advice, communication, and evaluation. We have wide-ranging experience in analyzing and evaluating data and generating required periodic reports such as the Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs).
Preparation and submission of aggregate reports
Gratisol Labs can work in conjunction with the customer and can help support the document preparation and submission of aggregate reports by providing the following services:
- Development and maintenance of an aggregate reporting schedule
- Planning of a preparation and review schedule with agreed timelines for all parties involved in the preparation and review, including requesting and collating information
- Generation of listings from the safety database
- Preparation of line-listings and tabulations for inclusion in the report
- Drafting, medical review, formatting of reports
- Submission of reports, including registration and submission of reports via centralised repositories for aggregate reports if required, including submission via PSUR centralised repository, Common European Submission Portal (CESP) and other portals for electronic submission
- Submission of reports by courier service in either paper or CD format
- Provision of quality metrics
- Management of assessment reports and responding to any questions that may arise from authorities
Why is aggregate reporting critical in Pharmacovigilance?
Though the Original case safety reports were tendered on an expedited basis to regulatory authorities, detailed analysis and evaluation of a drug’s benefit/risk ratio are not possible at this level. Therefore, periodically reviewing safety reports received cumulatively worldwide becomes highly significant to analyze the product’s benefit/risk balance. These reports need exceptional diligence and attention to detail, including an overview and a sense of what is essential, on the other hand.
At the individual case safety reports level, marketing authorization holders (MAH) can’t evaluate the benefit/risk ratio profile and understand a medicinal product’s detailed safety feature. In addition to presenting individual case safety reports, MAH also evaluates regular reviews of collective safety information obtained from various sources and presents the conclusions of aggregate reports to drug regulators.
Types of aggregate reports:
- Clinical study reports (CSR)
- Development Safety Update Report (DSUR)
- Periodic Safety Update Report (PSUR)/Periodic Benefit-Risk Evaluation Report (PBRER)
- Periodic Adverse Drug Experience Report (PADER).
- NDA and ANDA annual reports
Aggregate reporting is an indispensable tool to analyze a medicinal product’s benefit/risk balance throughout its life cycle.