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- Guidances for statistics in regulatory affairs are applicable to the pharmaceutical industry and medical devices industry. These Guidances represent the current thinking of regulatory agencies on a particular subject. It is to be noted that the term “Guidances” is used in the USA, whereas the term “Guidelines” is used in Europe. Regulatory affairs, also called government affairs, is a profession within regulated industries, such as pharmaceutical and medical devices, where professionals such as statisticians are expected to implement regulatory guidance into their work practices. Statisticians working in a regulated environment (e.g. the pharmaceutical and healthcare industry) are obliged to have a sound knowledge and understanding of the regulatory requirements that affect the design, conduct, analysis and reporting of their studies. Regulatory guidance for the pharmaceutical and medical devices industry can be found at the international level (e.g. ICH - International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), as well as at the regional/national level; for example:
* EMA - European Medicines Agency in Europe,
* MHRA - Medicines and Healthcare products Regulatory Agency in UK,
* IQWiG - Institute for Quality and Efficiency in Health Care in Germany,
* FDA - Food and Drug Administration in USA and
* PMDA - Pharmaceuticals and Medical Devices Agency in Japan. Furthermore, statistical regulatory guidance is found under general topics (e.g. Good Clinical Practice - ICH E6(R2)) and specific ones explicitly related to statistics (e.g. Statistical Principles for Clinical Trials - ICH E9 ) or not explicitly (e.g. Special Populations: Geriatrics [ICH E7] or Clinical Trial Endpoints in Oncology [FDA]). This large volume and diversity of regulatory guidances (draft and/or final ) is subject to revisions. Therefore, users of the guidances are advised to consult the original website to check for the latest version. Users are also encouraged to update the Wikipedia content The Wikipedia List of Guidances for Statistics in Regulatory Affairs provides links to various guidances under different topics. (en)
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- 7363 (xsd:nonNegativeInteger)
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- Guidances for statistics in regulatory affairs are applicable to the pharmaceutical industry and medical devices industry. These Guidances represent the current thinking of regulatory agencies on a particular subject. It is to be noted that the term “Guidances” is used in the USA, whereas the term “Guidelines” is used in Europe. Regulatory affairs, also called government affairs, is a profession within regulated industries, such as pharmaceutical and medical devices, where professionals such as statisticians are expected to implement regulatory guidance into their work practices. (en)
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- Guidances for statistics in regulatory affairs (en)
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