
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.
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.
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.
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.
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.
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