The company has been the industry leader in MedDRA and WHO-DRUG training since 1994. Our courses support the customization that our clients have come to expect while saving them time and money. The courses are scheduled in 90-minute blocks, which are more efficient than having your staff leave their desks for 1-3 days at a time.
Course Instructor
Dr. Joseph’s involvement with MedDRA began in 1993, as the expert medical informatics and autoencoding advisor on the FDA's Standardized Nomenclature Project. He is considered the leading authority on MedDRA and autoencoding, and more than 25 years of industry experience he has spoken, consulted, and published widely on coding and drug safety surveillance techniques.
MedDRA 101 – Overview (One 90-minute session)
Course Description
This course will provide a concise introduction to the MedDRA dictionary. Instruction is aimed at industry staff members who are interested in obtaining a general understanding of MedDRA’s impact on their work practices.
Course Objectives
MedDRA’s: Structure and content;
Business rules and conventions;
Strengths and deficiencies.
Course Prerequisites
Medical terminology;
At least one year’s experience with safety data in any phase of drug development.
MedDRA 201 – Coding Tutorial (Two 90-minute sessions)
Course Description
This 2-part course will demonstrate practical strategies for coding verbatim terms accurately and efficiently into MedDRA. Instruction is aimed at coders and other staff interested in the implications of MedDRA coding. Presentations will cover the management of general coding issues and the new challenges presented by the MedDRA philosophy, structure, content, and maintenance.
Course Objectives
Avoiding common coding problems;
Term selection options;
Reference development;
Coding conventions maintenance;
Autoencoding and browsing techniques.
Course Prerequisites
MedDRA 101, or equivalent training or experience;
Experience with a MedDRA browser;
At least one year’s experience coding with an industry adverse event dictionary.
MedDRA 301 – Analysis Tutorial (One 90-minute session)
Course Description
This course will demonstrate efficient techniques for retrieving data from MedDRA-coded databases, and using official and custom queries. Instruction is aimed at data manager, statisticians, medical writers, and other interested staff who are involved in safety surveillance, labeling, and regulatory affairs.
Course Objectives
Applying MedDRA’s multiaxial concept mappings;
Event monitoring and signal recognition techniques;
Using Standardised MedDRA Queries (SMQs);
Course Prerequisites
MedDRA 201, or equivalent hands-on MedDRA experience;
Adverse event surveillance requirements;
Clinical experience.
