Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submit the findings to regulators worldwide. Aggregate Reports refers to those reports that focus not so much on individual cases, but rather on overview, assessment of the safety profile and benefit-risk-evaluation.
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Introduction to Aggregate reporting |
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Introduction, scope, terminology, frequency and timing of PSURs/PBRERs |
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Comparision of PSUR and PBRER |
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GVP module VII/ICH E2C R2 guidelines |
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PADER and PBRER Scheduling |
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Data gathering |
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PADER Template |
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PBRER Template |
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PBRER Submission |
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Handling literature in aggregate reports |
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Guide on contents of PSURs in special situations/addendum PSURs/Safety statement |
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Introduction to Addendum to Clinical Overview (ACOs) |
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Sections of ACO (including appendices) |
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Signal detection |
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Signal assessment |
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Contents of DSUR as per guideline |
We will provide Aggregate Reporting Realtime case reports.
Yes.
If you miss a class we can provide recording video for particular session or we can arrange you the back up session.
Yes.
Once you are successfully through the course you will be awarded with Covalent's Training certificate.
Covalent certification has industry recognition and we are the preferred training partner for many MNCs.
Doubts clarification up to getting a job
Resume preparation
Mock interviews
Placement Assistance
Class Room & Online Live sessions
Real-time scenarios
Working faculties
Placement assistance
Resume preparation
Doubts clarification
Once you are successfully through the course you will be awarded with Covalent's Training certificate.
Covalent certification has industry recognition and we are the preferred training partner for many MNCs.
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