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MedDRA Training Certificate Course
Rating: 3.9 out of 5(366 ratings)
1,175 students

MedDRA Training Certificate Course

MedDRA, Medical Dictionary for Regulatory Activities, MSSO, SMQ, MTS: PTC, IME List
Last updated 5/2026
English
English [Auto],

What you'll learn

  • Introduction, Purpose and Basics of MedDRA
  • MedDRA Codes and Multi-Axial Terminology
  • MedDRA Dictionary Hierarchy/ Structure
  • Important Features of MedDRA
  • MedDRA: Strengths and Limitations
  • Standardized MedDRA Queries (SMQ)
  • MTS: PTC (MedDRA Term Selection: Points to Consider)
  • MedDRA Maintenance, WebCR, MedDRA tools
  • MedDRA Web Browser Demo
  • Important Medical Event (IME) List

Course content

6 sections23 lectures1h 51m total length
  • Introduction of MedDRA9:42

    Explore MedDRA, the medical dictionary for regulatory activities, used in pharmacovigilance and clinical data management to code adverse events, medical history, and product indications across global regulators.

  • Purpose and Advantages of MedDRA5:15

    Understand how MedDRA standardizes clinical information for global health authorities and pharmaceutical and biopharmaceutical companies, enabling consistent coding, harmonized terminology, and multilingual sharing across systems.

  • MedDRA Codes1:47

    MedDRA codes assign each medical term a unique eight-digit numeric code used for data fields in electronic submissions such as e-2b, with terms like anemia having code 10002034.

  • Multi-Axial Terminology3:12

    Explore the multiaxial terminology in MedDRA, showing how a single concept can link to two or more sources, enabling grouping, retrieval, and standardized data presentation while avoiding double counting.

  • MedDRA Hierarchy / Structure1:47

    Master MedDRA hierarchy from the lowest level term to system organ classes, including the preferred term, high level term, and high level group term, version 26.0 with 86,714 terms.

  • Strengths and Limitations of MedDRA5:35

    Assess MedDRA's strengths, including global alignment, multilingual availability, and precise signal detection, while noting limitations like incomplete coverage of clinical concepts and variability in adverse events coding.

  • Where MedDRA is used?1:44

    MedDRA is used across all clinical trial phases, from pre-clinical to phase four, and in regulatory and industry reporting for safety summaries, clinical study reports, investigator brochures, and prescribing information.

  • Important features of MedDRA4:55

    Explore the granular MedDRA terms, including specific diagnoses like toxic epidermal necrolysis and pneumocystis jiroveci pneumonia, along with signs, symptoms, lab values, outcomes, and misuse categories.

  • Quiz

Requirements

  • Laptop / PC/ Cellphone
  • Good Internet connection
  • Basic English

Description

The Medical Dictionary for Regulatory Activities (MedDRA) is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry.

This course of "MedDRA Training Certificate Course" is exclusively designed for Clinical Research professionals, Pharma students, Medical practitioners and Life science graduates.

This is one of the highly skilled Job Role in Clinical research.

The roles and responsibilities of this role are complex and challenging.

The Trainer of this course has more than 11+ years of Pharmacovigilance Industry Experience from different multinational companies (MNC). He has expertise in ICSR case processing, Aggregate Reports, Signal and Risk Management.


In this course we have covered following topics:


  • Introduction, Purpose and Basics of MedDRA

  • MedDRA Codes

  • Multi-Axial Terminology

  • MedDRA Dictionary Hierarchy/ Structure

  • Important Features of MedDRA

  • MedDRA: Strengths and Limitations

  • Standardized MedDRA Queries (SMQ): Structures, Narrow and Broad Searches, Algorithmic SMQs, Benefits and Limitations, Applications

  • MTS: PTC [MedDRA Term Selection: Points to Consider]

  • MedDRA Maintenance, WebCR, MedDRA tools and IME List

  • MedDRA Web Browser Demo

By completing this course, you will be able to know how MedDRA works.


So, what are you waiting for? Enroll and join us in this exciting course. See you soon in the class.


Thanks & Regards,

PV Drug Safety Academy

Who this course is for:

  • Clinical Research professionals
  • Pharmacovigilance professionals
  • Pharmacy, Medical and Life science students