
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.
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 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.
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.
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.
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.
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.
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.
Explore standardized MedDRA queries (SMCs), groups of related medical terms under one clinical concept, created to resolve coding disputes in adverse event assessment since version 15.1.
Explore the structures of SMQs, including standalone SMCs with direct PIDs and main SMCs with multiple sub SMCs. Note that, unlike the MedDRA hierarchy, PIDs link to sub SMCs.
Learn to select between narrow and broad SMC in MedDRA analysis, recognizing that broad includes narrow terms and increases data and sensitivity, while narrow provides specificity.
Explore algorithmic smc within the broad and narrow smc framework, using defined event-term combinations to identify valid cases. See anaphylactic reaction across categories a–d and dress syndrome examples.
Explore the benefits, limitations, and applications of SMQ in pharmacovigilance and clinical data management, including standardized communication, algorithmic use, and signal detection across trials and post-marketing.
Discover how MTS:PTC guides Meddra term selection, showing March updates and global coding consistency through regulatory, industry, and WHO roles, with medical judgment on a case-by-case basis.
Explore how MedDRA maintenance handles change requests via the maintenance and support service organization, with up to 100 requests per month and rigorous physician review to update adverse event terms.
Learn how to submit a web change request online, with medical rationale, using the MedDRA change request tool, including fields, login credentials, justification, and attachments.
Explore MedDRA tools, including the desktop browser, web-based mirror browser, and mobile browser, each designed for easy searches and analysis across platforms.
Explain the important medical events (IME) list, its use with designated medical events (DME), and how MedDRA updates guided by the EudraVigilance Expert Working Group drive EMA pharmacovigilance, version 27.1.
Explore why coding conventions are essential in MedDRA coding with Matera, unifying coders' medical judgment for consistent terminology and balancing automated encoding with manual coding for reliable signal assessment.
Apply general MedDRA coding principles by selecting the lowest level term that best matches the latest MedDRA version and the reported adverse event, including device related terms.
Explore MedDRA coding examples, from specificity and symptoms to investigations with troponin and CPK, patient demographics, medication errors, product quality issues, and outcomes.
Log in to the MedDRA web browser, explore concepts, legends, and SMCs, and learn to use search history, versioning, and exporting SMC data to Excel.
Congratulations on completing the course; retrieve your certificate from your profile, share it on LinkedIn, and access downloadable materials and Q&A on Udemy to explore pharmacovigilance and MedDRA courses.
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