What is MedDRA? MedDRA, or the Medical Dictionary for Regulatory Activities, is a clinically validated international medical terminology used by regulatory authorities and the biopharmaceutical industry.
Who developed MedDRA? MedDRA was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
How is MedDRA organized? MedDRA is organized in a hierarchical structure, with five levels: System Organ Class (SOC), High-Level Group Term (HLGT), High-Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).
How is MedDRA used? MedDRA is used throughout the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
What are the advantages of MedDRA? MedDRA offers several advantages including universality, precision, flexibility, and standardization.
Is MedDRA available in different languages? Yes, MedDRA is available in several languages, making it accessible to people all over the world.
How can I access MedDRA? Access to MedDRA is through a subscription model, which provides access to the complete MedDRA terminology in all supported languages, as well as a range of tools and resources.
What training and support are available for MedDRA users? MedDRA offers a range of training and support services, including the MedDRA Training Program and MedDRA Support Services.
What is the future of MedDRA? The future of MedDRA lies in its expansion, accessibility, and innovation. It is set to remain a crucial tool in the medical field for years to come.
Where can I find more information about MedDRA? More information about MedDRA can be found on the official MedDRA website.