Training

ThesIS offers a variety of training classes on MedDRA and WHO Drug, as well one-on-one training for coding.

Our training classes incorporate the unique insights and experience amassed from our extensive use of these dictionaries. The classes are available by specific arrangement with your company and are typically given on-site, with no limit to the number of people from your company who can attend. Any class can also be customized to your needs.

MedDRA Classes
WHO Drug Classes
One-on-One Training

MedDRA Classes

Introduction to MedDRA

This introductory class covers the fundamentals of MedDRA and is especially well-suited not only for coders but also for statisticians, medical reviewers, and others who will be working with MedDRA-coded data.

The Introduction to MedDRA class covers the following topics:

• History
• MSSO
• Structure and Content
• Comparison to COSTART
• Coding and the Points to Consider Document
• Standardised MedDRA Queries (SMQs)
• Versioning
• CTCAE Mapping to MedDRA
• Regulatory Expectations

The duration of the Introduction to MedDRA class is 1.5 to 2 hours.

MedDRA Coding

This class is directed to individuals who already have some familiarity with MedDRA but desire more in-depth training on how to properly code using MedDRA. Participants in the class should also have some medical knowledge as the course will go into detail about specific medical concepts. A primary objective of this class will be on the use of the “MedDRA Term Selection: Points to Consider” document to determine proper selection of MedDRA lowest level terms when coding.

The MedDRA Coding class covers the following topics:

• Review of MedDRA
• Rules and Conventions Used In MedDRA
• MedDRA Term Selection: Points to Consider Document
  • Detailed Discussion of Each of the Term Selection Points
  • Discussion of the Coding Examples Provided in the “Points to Consider” Document
  • Additional Coding Examples to Further Explain the Term Selection Points
• How to Code Terms Not Covered by the “Points to Consider” Document
• Importance of Company Coding Conventions
• Using the MedDRA Browser
• Change Request Process

The duration of the MedDRA Coding class is 7 to 8 hours.

Best Practices for MedDRA Versioning

This class is targeted to those individuals who are tasked with creating an effective MedDRA versioning strategy. It discusses the rationale for versioning on an ongoing basis and presents a practical strategy that enables complete versioning with minimal impact.

The Best Practices for MedDRA Versioning class covers the following topics:

• MedDRA Versions: Recap
• Why Continually Update to Each Version?
• Methods for Versioning
• Impact of Versioning
• Keys to Success

The duration of the Best Practices for MedDRA Versioning class is one hour.

WHO Drug Classes

Introduction to WHO Drug

This introductory class covers the fundamentals of WHO Drug and is especially well-suited not only for coders but also for statisticians, medical reviewers, and others who will be working with WHO Drug-coded data.

The Introduction to WHO Drug class covers the following topics:

• Dictionary Types
• Format Definitions
• Structure and Content
• Drug Code
• Ingredients vs. Preferred Names
• Standardized Drug Queries (SDQs)
• Versioning
• Considerations and Challenges for
  • Coding
  • ATC Selection
  • Analysis
  • Versioning
• Recommendations

The duration of the Introduction to WHO Drug class is 2 to 2.5 hours.

WHO Drug Coding

This class is directed to individuals who already have some familiarity with WHO Drug but desire more in-depth training on how to properly code using WHO Drug.

The WHO Drug Coding class covers the following topics:

• Review of WHO Drug
• Identifying the Drug
  • Using a "Fuzzy" Search Engine
  • Search Using Google
  • Martindale Online
  • Other Web Resources
• General Principles for Selecting the Appropriate WHO Drug Entry
• Abbreviations
• Handling Drugs with Multiple WHO Drug Entries
• Special Rules for Coding Certain Drugs and Drug Categories
• Multi-Ingredient Drugs
• Querying Terms
• Importance of Company Coding Conventions
• Change Request Process

The duration of the WHO Drug Coding class is six hours.

One-on-One Training

ThesIS offers one-on-one training for both MedDRA and WHO Drug. This training is intended to supplement "standard" MedDRA and WHO Drug coding classes. Training one-on-one with a ThesIS expert enables your coder(s) to get a better and more specific understanding of MedDRA and WHO Drug than is achievable through a class setting.