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Aggregate Reporting (Entry Level)

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.

Why this course ?

The periodic reports plays an important role in risk-benefit evaluation of the drug and involves collective analysis of cases in the database, monitoring regulatory actions, literature searches etc. They are required to be submitted to various regulatory agencies to comply with the regulatory requirements. The advantage of aggregate reporting is that it provides a broader view of the safety profile of a drug.

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

Download
  • Aggregate Reporting Entry 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)

Projects

  • Aggregate Reporting 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
    Lab facilities
    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

Reviews

Mir Firasath Ali

Sr. Drug Safety Associate

Wonderful Training by Mr. Gaurav and Great support by Covalent Management.

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Nidhi Pathak

Sr. Drug Safety Associate

First I would like to Thank you Mr. Gaurav for providing me the best real time Training on Aggregate reporting covering Introdcution, PSUR & PBRER, Signal detection, evaluation etc. Worked on realtime scenarios. Thank you Covalent.

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Anusha

Drug Safety Specialist - Aggregate Reporting

Aggregate Reporting trainer at Covalent comes from MNC with 12+ years of realtime experience. He is very knowledgeable and supportive. I must say this training makes you job-ready.

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Gayathri P

Fresher

Good institute for technical training's. I received prompt schedule from ecorp team and they managed perfectly according to schedule. Trainers are also very efficient.

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Maheshwari

Drug Safety Associate

While there are many training institutes in the city, Covalent is a class apart due to the quality of its instructor and the attention given to the individual learners.

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NALAJAM SUDHAKAR

Fresher

Really satisfied with the training that was being given here. Great support from faculty as well as Administration team. The team has the best support in providing the materials.

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