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The code revision has been followed by Ethoscope [8] – an open-source, continuously evolving resource that contains diverse guidance designed to keep pace with emerging developments. The pharmaceutical industry contributes to the Sustainable Development Goals ( SDGs ), in particular Goal 3 to ensure healthy lives and promote well-being for ...
The CMA Code of Ethics and Professionalism (Code) is a document produced by the Canadian Medical Association. The Code articulates the ethical and professional commitments and responsibilities of the medical profession in Canada. [1]
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as "Attachment X", "Page X of X", signed and dated by person who attached it, etc.)
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies.Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]
A code of practice is adopted by a profession (or by a governmental or non-governmental organization) to regulate that profession. A code of practice may be styled as a code of professional responsibility, which will discuss difficult issues and difficult decisions that will often need to be made, and then provide a clear account of what behavior is considered "ethical" or "correct" or "right ...
Medical Code of Ethics is a document that establishes the ethical rules of behaviour of all healthcare professionals, such as registered medical practitioners, physicians, dental practitioners, psychiatrists, psychologists, defining the priorities of their professional work, showing the principles in the relations with patients, other physicians and the rest of community.