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In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Improving the efficiency and effectiveness of evidence-based guideline development, adaptation, dissemination and implementation; Building a Network and partnerships for guideline developing organisations, end users (such as health care providers, healthcare policy makers and consumers) and stakeholders.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Many guidelines and governance bodies have been established to ensure a common approach within a given industry to a set of parameters used to identify the minimally acceptable standard for that industry. The pharmaceutical industry is no exception, with several trade groups (e.g. PhRMA, EFPIA, RQA, etc.) coming together to enhance collaboration.
The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [1] [2] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [3] and Switzerland. [1]
Plates vi & vii of the Edwin Smith Papyrus (around the 17th century BC), among the earliest medical guidelines. A medical guideline (also called a clinical guideline, standard treatment guideline, or clinical practice guideline) is a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare.
Fundamentally healthcare and hospital accreditation is about improving how care is delivered to patients and the quality of the care they receive. Accreditation has been defined as "A self-assessment and external peer assessment process used by health care organisations to accurately assess their level of performance in relation to established standards and to implement ways to continuously ...
The International Classification of Health Interventions (ICHI) is a system of classifying procedure codes being developed by the World Health Organization (WHO). It is currently available as a beta 3 release. The components for clinical documentation are stable. The component on public health interventions is in the process of being finalized.