What does MedDRA mean?
Medical Dictionary for Regulatory Activities
The Medical Dictionary for Regulatory Activities (MedDRA) Terminology is the international medical terminology developed under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.
What is MedDRA and how is it used?
MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre- marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
Where is MedDRA used?
It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorised for sale. Products covered by the scope of MedDRA include pharmaceuticals, vaccines and drug-device combination products.
Why is MedDRA used?
MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multiaxial hierarchy or through the special feature of Standardised MedDRA Queries.
What is MedDRA clinical trials?
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the …
What is the difference between MedDRA and WHO drug dictionary?
In the WHO Drug case, it will be the variable pertaining to the drug name while the MedDRA case is referring to the adverse event verbatim variable. The other distinction is that the WHO Drug can also have an indication and route variable.
What is the difference between MedDRA and WHO Drug dictionary?
What does Whodrug stand for?
The WHO Drug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre.
How many MedDRA terms are there?
There are five levels to the MedDRA hierarchy, arranged from very specific to very general. At the most specific level, called “Lowest Level Terms” (LLTs), there are more than 80,000 terms which parallel how information is communicated.
Which is better clinical research or medical coding?
Clinical Research has more opportunities than Medical coding. Clinical Research deals with research aspects of new drugs & formulations. It deals with research project designing and research project management as per GCP guidelines.
What is the difference between MedDRA and WHO Drug Dictionary?