AGGREGATE REPORTING IN PHARMACOVIGILANCE

Aggregate reporting in pharmacovigilance refers to the process of collecting and analyzing data from multiple sources, such as clinical trials, post-marketing surveillance, and spontaneous adverse event reporting, to identify patterns or trends in the safety of a drug or medical product. The goal of aggregate reporting is to provide a comprehensive and accurate overview of the safety profile of a drug or medical product, and to identify any potential safety concerns.

Aggregate reports are typically required by regulatory authorities as part of the pharmacovigilance requirements for drug and medical product approval and post-marketing surveillance. These reports are also used by manufacturers to monitor the safety of their products and to make decisions regarding product labeling and risk management.

The most common types of aggregate reports in pharmacovigilance include periodic safety update reports (PSURs), which provide a comprehensive overview of the safety profile of a drug or medical product over a specified time period, and signal detection reports, which identify potential safety signals or concerns based on analysis of adverse event data.

The process of aggregate reporting typically involves the collection and analysis of data from multiple sources, including clinical trials, post-marketing surveillance, and spontaneous adverse event reporting. This data is then analyzed using statistical methods to identify patterns or trends in the safety of the drug or medical product. The results of this analysis are then compiled into a comprehensive report, which includes a summary of the safety profile of the drug or medical product, any identified safety concerns, and recommendations for further monitoring or risk management.

1. Welcome AGGREGATE REPORTING IN PHARMACOVIGILANCE RUKHAYYA PHARM.D CSRPL_STD_IND_HYD_ONL/CLS_014/012023 2/16/2023 www.clinosol.com | follow us on social media @clinosolresearch 1

2. Index INTRODUCTION IMPORTANCE OF AGGREGATE REPORTING TYPES OF AGGREGATE REPORTING KEY TERMINOLOGIES AND SUBMISSION SCHEDULES VALUE CHAIN AND ACTIVITIES 2/16/2023 www.clinosol.com | follow us on social media @clinosolresearch 2

3. INTRODUCTION: Aggregate reporting is a process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submit the findings to regulators worldwide. The aggregate safety reports are presented to regulators as soon as the medicine is marketed anywhere in the world and enables understanding of risk and benefit profile of the product over a period of time. These reports focus not so much on individual cases, but rather 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. 2/16/2023 www.clinosol.com | follow us on social media @clinosolresearch 3

4. IMPORTANCE OF AGGREGATE REPORTING Why aggregate reporting is important? Though the Individual case safety reports were submitted on expedited basis to regulatory authorities, detailed analysis and evaluation of benefit/risk ratio of a drug is not possible at this level. Therefore periodically reviewing safety reports received cumulatively worldwide, becomes highly significant to analyze the benefit/risk balance of the product. These reports need special diligence and attention to detail on the one hand, overview and a sense of what is essential on the other hand. Assessment Aims Standardized Balanced benefit-risk assessment • Authorization or Renewal • Relate safety evaluation with exposure • Identify New safety concerns • Changes to the RSI 2/16/2023 www.clinosol.com | follow us on social media @clinosolresearch 4

5. TYPES OF AGGREGATE REPORTS: Types of aggregate reports: Pre-marketing report: IND annual reports Clinical study reports (CSR) Development Safety Update Report (DSUR) Annual safety reports (ASRs) in Europe Post-marketing report: Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report(PSUR) • Periodic Adverse Drug Experience Report (PADER) .• NDA and ANDA annual reports • Addendum to clinical overviews (ACO) 2/16/2023 www.clinosol.com | follow us on social media @clinosolresearch 5

6. KEY TERMINOLOGIES AND SUBMISSION SCHEDULES Development International Birth Date(DIBD ) - The date authorization is obtained to conduct clinical trials in any country • International Birth date (IBD) - The date of the first marketing authorization, the EU birth date is the date of the first authorization in Europe • Data Lock Point (DLP)- The cut off date for data to be included in theDSUR • Reference Safety Information (RSI) -A document containing a cumulative list of all the adverse events observed. 2/16/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

7. VALUE CHAIN AND ACTIVITIES 2/16/2023 www.clinosol.com | follow us on social media @clinosolresearch 7

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