Qtech-Sol Professional Development Center

Advanced Drug Safety – Pharmacovigilance Program (ADPP)

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  • Curriculum Overview

    Designed by industry experts for students and young professionals. The training program provides in depth knowledge of roles and responsibilities of Drug Safety / Pharmacovigilance Specialist including theoretical aspect of the field and exposure to variety exercises based on industry requirements.

    ADDITIONAL DRUG SAFETY-PHARMACOVIGILANCE

    LIST OF TOPICS:

    1.  Introduction to MedDRA

    2.  MedDRA Coding Guidelines- Part 1

    3.  MedDRA Coding Guidelines- Part 2

    4.  MedDRA Coding Guidelines- Part 3

    5.  MedDRA Coding Guidelines- Part 4

    6.  AE Causality assessments

    7.  ICSR Medical Causality assessment

    8.  Introduction to Risk Management Plan (RMP)

    9.  Introduction to Risk Management Plan (REMS)

    10.  Argus Safety End-User Training - Module 1

    11.  Argus Safety End-User Training - Module 2

    12.  Argus Safety End-User Training - Module 3

    13.  Argus Safety End-User Training - Module 4

    14.  Argus Safety End-User Training - Module 5

    15.  Product Quality Complaints (PTC / PQC)

    16.  Corrective and Preventative Actions (CAPAs)

    17.  Overview of Aggregate Reporting (PSUR/ PBRER)

    18.  Overview of Aggregate Reporting - PADER

    19.  Overview of Aggregate Reporting - PRAC / DSUR



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