This workshop provides a forum for an inside look at the commonly encountered issues and the possible solutions and their implications. The workshop design encourages audience participation by asking delegates to share their MedDRA experience. Each topic is supported by a presentation, examples and a discussion. In this way specific concerns are adequately addressed.

Workshop Objectives:

§        Present challenges and strategies learned through MedDRA implementation and daily application

§        Identify issues shared by participants through an interactive session

§        Discuss possible solutions to problem areas

§        Apply theory to real life examples

Workshop Outline:

1. MedDRA Implementation

Regulatory status

MedDRA implementation examples

MedDRA implementation processes

2. MedDRA Coding practices

Capturing the medical concepts

Internal coding guidelines

- Creation and application

- Coding guidelines maintenance

- Exceptions to the rules documentation

Strategy for coding challenging verbatims

Processing AE file vs. History file vs. Indications

Data extraction from narratives

Work flow

3. Legacy data conversion issues

4. MedDRA Quality Assurance (QA)

Concepts in QA

- Uniformity across coders

- Uniformity across verbatim text concepts

- Consistency over time

Training

- Documenting the process

- Tracking results and feedback

5. Internal MedDRA Maintenance

MedDRA Management team

Synonym table

- Criteria for inclusion

- Provisional/approved additions

- Synonym table QA

Change requests

6. MedDRA up-versioning

Post marketing vs. Clinical

7. Implications of MedDRA and Internal Coding Guidelines on Data Analysis and Extraction

Discussion of examples demonstrating the impact of coding on data management and retrieval

Discussion of examples demonstrating the impact of coding on data presentation

8. Q & A