Did you know that by 15 March 2019, the FDA will only support submissions in the new WHO Drug Global B3 or C3 formats? The older B2 and C formats will no longer be accepted. There will be a number of significant changes that will affect your coding practices and reporting systems. Are you prepared?
- Does your system support a drug name of 1,500 characters?
- How well is your coding systems learning from your decisions?
- Can you teach your coding system to better aid you in coding decisions?
- Can your coding system “see” past the clutter in verbatim terms? For example “5/5/18 FX to left leg” should auto-code to the MedDRA term “Leg fracture”
Learn from renowned industry expert Kim Rejndrup, SVP of Development, OmniComm Systems, holder of two coding patents, who will walk you through the considerations in adopting the new WHO Drug formats. He will also cover the general principles of what you should expect from a coding system.
Kim Rejndrup,
Senior Vice President Development
Kim Rejndrup, senior vice president - Development, is helping drive OmniComm’s products to new levels of innovation. Mr. Rejndrup spent nearly 20 years at Oracle Corporation, where he was a vice president of Development for many clinical research applications, including systems for electronic data capture (EDC), clinical trials management, data management, medical coding and data warehousing.
- You will learn how to use WHO Drug B3/C3 in compliance with the CM domain in the CDISC STDM standard.
- You will learn how a coding system should learn from your decisions to make better coding recommendations.
- You will learn how a coding system should be able to invoke different verbatim term manipulation and matching strategies to provide better coding recommendations.
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