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An IS0 9001:2015 Certified Institute

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

Topic : 2 Introduction to Aggregate Reporting

Topic : 3 Introduction to Risk Management Plan

  Topic: 4 Introduction to Signal Management Process

Course Features

Instructor Live Sessions

There will be allocated hours of instructor with Live classroom and Simultaneously on Online.

Real Time Studies

Live project based on any of the selected use cases on the above selected Domain.

Assignments

Each class will be followed by practical assignments which can be completed before the next class.

24/7 Support

We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.

Certification

Towards the end of the course, you will be working on a project. Sadhana Infotech certifies you as an course Expert based on the project.

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