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Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines and ethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility ...
The QPPV must reside in the EU, and should be permanently and continuously at the disposal of the MAH. Each company (i.e. Applicant/Marketing Authorisation Holder or group of Marketing Authorisation Holders using a common pharmacovigilance system) should appoint one QPPV responsible for overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations ...
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.
It is also a benefactor of Health Level Seven International, [10] a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [11] and the International Pharmaceutical Regulators Programme (IPRP), [12] and a partner of the Society for Immunotherapy of Cancer [13] and Vaccine Confidence ...
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In employment law, a bona fide occupational qualification (BFOQ) (US), bona fide occupational requirement (BFOR) (Canada), or genuine occupational qualification (GOQ) (UK) is a quality or an attribute that employers are allowed to consider when making decisions on the hiring and retention of employees—a quality that when considered in other contexts would constitute discrimination in ...
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
The Bureau of Labor Statistics (BLS) maintains the Direct Match Title File (DMTF) that contains job titles that match detailed occupations in the SOC. [5] For example, the following job titles all match to the occupation Bill and Account Collectors (SOC code of 43-3011): Collection Agent, Collections Clerk, Collections Representative, Debt Collector, Installment Agent, Installment Loan ...