An Introduction to MedDRA and MedDRA Coding
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Speaker : GRAEME LADDS
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When : Wednesday, October 23, 2024
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Time : 12 : 00 PM EST
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Graeme Ladds, Director of PharSafer, has over 30 years of experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1990 and becoming Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals and has also served as EU QP PV at many top ten Pharma Companies. The last twenty-one years have been spent in his consultancy company, PharSafer Associates Ltd, a niche CRO specializing in performing pharmacovigilance for many Companies around the world. During this time, Graeme has been involved in establishing Pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP PV for companies, and helping with regulatory inspections.
Graeme is also the inventor of RAPTAR – an automated safety case processing tool that enhances case processing accuracy, and speed and provides cost savings for Companies serious about safety
MedDRA was introduced in the late 1990s. The aim was to unify the way that all aspects of medical terminologies for indications; lab data, signs, symptoms, and diagnoses were unified globally.
Up until this time various different coding mechanisms were used – WHO-ART; HARTS; CO-START and others.
Now with a unified system came the challenge of learning to code one way consistently and globally. This meant also translating MedDRA into multiple languages without diluting or changing the meaning of the various terms. This course is designed to show what is needed to be put in place to understand and use MedDRA from case processing to signal detection.
Areas Covered
- What is MedDRA used for?
- How is MedDRA to be Used?
- Understanding how to Code with MedDRA
- Keeping MedDRA up to date
Who Should Attend
- PV Compliance
- Regulatory
- EU QP PVs
- Clinical Staff
- Director/Manager of Pharmacovigilance
- PV QA
Why Should You Attend
This course is essential for those working in the area of drug safety/pharmacovigilance who will be using the MedDRA system daily. Equally, those people using MedDRA for labeling activities or QA for auditing purposes need to know how the system should be used effectively in order that they can assess the Company's compliance in using the system.
Regulatory Authorities routinely assess Company MedDRA coding capabilities during inspections, whether in the clinical setting or post-marketing and so it is essential to understand how the Company uses MedDRA and its various versions when issued.
Topic Background
MedDRA coding for adverse reactions and many other aspects of drug safety over the last 25 years has become an essential tool for pharmacovigilance activities globally.
It is vital to understand fully how to utilize such a system to ensure patient safety and help healthcare professionals understand the risks associated with each product accurately before treating their patients.
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$199.00
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