Course Length:

1.5 days

Recommendations:

If you intend to participate in this course, participation in the MedDRA Basics course is not recommended.

Objectives:

§        Provide users with an in-depth understanding of the MedDRA structure

§        Provide users with specific knowledge of coding concepts applicable to MedDRA

§        Provide extensive, hands-on, practical coding experience with MedDRA from both the clinical safety and drug safety (pharmacovigilance) perspective

§        Provide users with detailed understanding of the ICH MedDRA Terms Selection: Points to Consider classification guidelines

§        Provide an overview of MedDRA ‘s impact on data management

Course Benefits:

At the conclusion of this course, participants will be able to:

§        Use a MedDRA tool to browse for terms

§        Utilize the full MedDRA hierarchy during term selection

§        Navigate and validate MedDRA with confidence

§        Appreciate the need for and appropriately apply ICH classification guidelines

§        Identify coding issues which require internal vs. external resolution

Course Outline:

Day 1:

1.      MedDRA Background

§        Coding concepts

-         Objectives of coding

-         Legacy Dictionaries

§        MedDRA intent and scope

2.      MedDRA Structure

§       Hierarchical structure

-         Detailed discussion of organization of terms at the 5 levels

§       Multiaxial structure

-         Primary/Secondary SOCs

-         Benefit of multiaxiality

§       Associative structure/SSCs/SMQs

§       Dictionary rules and conventions

3.      Coding Guidelines

§       Necessity for coding guidelines

§       Discussion of ICH PTC guidelines

§       Company specific coding guidelines

4.      MedDRA "Tools"

§       Autoencoder

§       Browser

§       Reference texts

-         Coder's manual

-         Medical abbreviations - common versus standard

-         Lab references

-         Medical text

-         Medical dictionary

§       Online Resources

5.      Q&A

End of Day 1

Day 2:

6.      MedDRA Coding: Applications and Implications

§       MedDRA coding techniques

-         Top down approach

-         Bottom up approach

§       Applying classroom theory to real life examples using company specific data and applying company specific coding guidelines

-         Clinical safety perspective (verbatim string text exercises)

-         Drug safety (pharmacovigilance) - coding from actual post-marketing reports

§       Explanation of the step-by-step thought process required to find the most appropriate LLT in MedDRA

-         Re-enforcing guidelines and MedDRA conventions through approximately 50 challenging hands-on exercises

-         Identification of internal (company guideline) versus external (MedDRA) related issues in the practice exercises

7.      MedDRA Validation Techniques

§       Present and discuss examples of why MedDRA needs to be validated

§       Validation from a structural perspective

-         Verifying associations within MedDRA are valid

§       Validation from a clinical perspective

-         Verifying appropriate use of terminology

-         How MedDRA structure may be used to validate user’s understanding of the term

8.     MedDRA Maintenance

§       External maintenance

§       Internal maintenance

§       MedDRA management team

§       Change request process

-         MSSO

-         Internal tracking process

-         Updates

9.     Summary Q&A

End of Day 2