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Aggregate Reporting (Advanced Level)

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.


Why this course ?

At basic pharmacovigilance, though the individual case safety reports were submitted on expedited basis to health authorities, detailed analysis and evaluation of benefit/risk ratio of a drug is not possible at this level. Therefore, analysis of safety-reports analyzed cumulatively becomes highly significant to analyze the benefit/risk balance of product and taking appropriate actions where signals, new risks or changes to known risks are identified.

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real-time Case 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 x 7 Expert 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. Covalent certifies you as an course Expert based on the project.

Course Curriculum

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  • Aggregate Reporting (Advanced Level) Content

    Introduction to Aggregate reporting

    Introduction, scope, terminology, frequency and timing of PSURs/PBRERs

    Comparision of PSUR and PBRER

    GVP module VII/ICH E2C R2 guidelines

    PADER and PBRER Scheduling

    Data gathering

    PADER Template

    PBRER Template

    PBRER Submission

    Handling literature in aggregate reports

    Guide on contents of PSURs in special situations/addendum PSURs/Safety statement

    Introduction to Addendum to Clinical Overview (ACOs)

    Sections of ACO (including appendices)

    Signal detection

    Signal assessment

    Contents of DSUR as per guideline

Projects

  • Aggregate Reporting (Advanced Level) Project

    We will provide Aggregate Reporting Realtime case reports.

FAQ's

  • Can I attend a demo session before enrollment?

    Yes.

  • What if I miss a class ?

     If you miss a class we can provide recording video for particular session or we can arrange you the back up session.

  • Will I get placement Assistance ?

    Yes.

  • Do I receive a certificate for training ?

    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.

  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Mock interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real-time scenarios
    Working faculties
    Placement assistance
    Resume preparation
    Doubts clarification

Certifications

  • Course completion certificate

    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.

Videos

Aggregate Reporting (Advanced Level)

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