Aggregate Reporting

Aggregate Reporting

About the course:-

Aggregate reporting, also known as periodic reporting, plays a key role in the safety assessment of drugs. Aggregate reporting involves the compilation of safety data for a drug over a prolonged period of time (months or years), as opposed to single-case reporting which, by definition, involves only individual AE reports. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug. Worldwide, the most important aggregate report is the Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR). This is a document that is submitted to drug regulatory agencies in Europe, the US and Japan (ICH countries), as well as other countries around the world. The PSUR was updated in 2012 and is now referred to in many countries as the Periodic Benefit Risk Evaluation report (PBRER). As the title suggests, the PBRER's focus is on the benefit-risk profile of the drug, which includes a review of relevant safety data compiled for a drug product since its development.

Objective of the course:-

THIS COURSE IS BEST SUITABLE FOR SERIOUS JOB ASPIRANTS CHOOSING MEDICAL REPORTING AS THEIR PROFESSION

Course Syllabus

Topic : 1 Introduction to Pharmacovigilance

• Introduction to ICH-E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting.
• Introduction to Clinical Trials
• Medical Information Centre
• Literature Search & Analysis in case processing
• Argus safety database access and management
• Case Processing & Regulatory Reporting
• EU EudraVigilance Case Management

Topic : 2 Introduction to Aggregate Reporting

• Scope, terminology, initiation, process, distribution and frequency of submission of Global Aggregate reports (PSURs/PBRERs/PADER/ACO)
• Periodic Aggregate Reports Preparation and Medical Review of Global Aggregate Reports (PSURs/PBRERs/PADER/ACO)
• GVP Module VII/ICH E2C R2 guidelines
• Template demonstration of PSURs/PBRERs/PADER/ACO
• Handling literature in aggregate reports

Topic : 3 Introduction to Risk Management Plan

• GVP Module V – Risk management systems
• Benefit-risk analysis evaluation

  Topic: 4 Introduction to Signal Management Process

• GVP Module IX – Signal management
• Signal detection, validation & confirmation
• Signal analysis and prioritisation
•  Signal assessment and recommendation for action 
• Signal and risk evaluation
•  Benefit evaluation