- 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.
Frequently Asked Questions
