Category:
Drug Safety |
Duration: 3 Weeks / 80 Hours |
MedDRA & WHO-DD Coding – Basics
Accurate medical coding is one of the most critical steps in pharmacovigilance (PV) and clinical research. Coding ensures that adverse events (AEs), medical history, and medications are captured consistently and standardized across global databases, enabling regulators, sponsors, and safety teams to interpret safety data reliably.
The MDRA: MedDRA & WHO-DD Coding – Basics program introduces learners to the Medical Dictionary for Regulatory Activities (MedDRA) and the World Health Organization Drug Dictionary (WHO-DD), both widely used in safety case processing and regulatory submissions. This program equips students with the foundational knowledge and practical understanding of medical coding, preparing them for real-world roles in PV and drug safety operations.
SIP – Self-Paced Online with Support
- Course Duration: 3 weeks (80 hours)
- Format: Self-Paced Online with Support (presentations, readings, quizzes, and case-based coding practice).
By the end of this course, learners will:
- Understand the purpose and importance of medical coding in pharmacovigilance.
- Gain an overview of the MedDRA hierarchy (System Organ Class → High Level → Preferred Term → Lowest Level Term).
- Learn how to code AEs and SAEs using MedDRA consistently.
- Understand the WHO-DD structure and its role in coding concomitant medications.
- Recognize the impact of accurate coding on signal detection, safety reporting, and regulatory submissions.
- Perform basic case exercises to reinforce practical coding application.
- Drug Safety / PV Associates learning case processing.
- Clinical Research staff handling AE reporting.
- Healthcare professionals moving into PV and regulatory roles.
- Career changers seeking entry into drug safety and clinical data management.
- Gain hands-on knowledge of MedDRA and WHO-DD coding.
- Learn to apply coding rules for case safety reporting (ICSRs).
- Improve job readiness for PV case processor and coding specialist roles.
- Build a foundation for advanced PV tools (e.g., Argus Safety, ArisG).
- Contribute to quality data used for regulatory compliance and patient safety.
- Drug Safety Associate (DSA)
- ICSR Case Processor
- Coding Specialist (MedDRA / WHO-DD)
- Pharmacovigilance Associate
- Clinical Data Specialist
Modules | |
1. Introduction to Medical Coding in Pharmacovigilance
2. Overview of MedDRA – History, Purpose, and Global Use 3. MedDRA Hierarchy & Structure Explained 4. Principles of Coding AEs and SAEs 5. Common Coding Challenges & Best Practices 6. WHO-DD Overview – Structure, Use, and Applications 7. Coding Concomitant Medications & Medical History 8. Linking Coding to Case Processing & ICSR Reporting 9. Coding and Its Role in Signal Detection & Analysis 10. Case Studies – Practical Coding Scenarios |
For more information, please call us at +91 8925971788 / +91 8977943100 (WhatsApp)or email qpdc@qtechelearncenter.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.