Overview:

This advanced course provides a deep dive into the essential coding systems used in Pharmacovigilance—MedDRA (Medical Dictionary for Regulatory Activities) and WHO-Drug. It focuses on understanding the structure, hierarchy, and conventions of these coding dictionaries, and provides hands-on training in coding medical events and drugs. This course is critical for ensuring consistency, accuracy, and compliance in ICSR processing and reporting.

Objectives:

1. To understand the structure, organization, and functionalities of MedDRA and WHO-Drug dictionaries.
2. To master the coding conventions and best practices for medical terms and drug names.
3. To apply coding skills to real-life case studies and ensure regulatory compliance.
4. To handle advanced scenarios such as special situations, complex medical terms, and synonym matching in coding.

Outcomes:

By the end of this course, learners will:

• Demonstrate proficiency in coding medical events using MedDRA and drug information using WHO-Drug dictionaries.
• Ensure consistency and accuracy in medical coding for ICSR processing.
• Apply advanced coding techniques to handle complex cases and special scenarios.
• Maintain compliance with global regulatory requirements for coding practices.