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The guideline is not intended to give a detailed understanding of the meta-analytic techniques described, but rather to explain the main strengths and weaknesses of the methodologies. The guideline discusses some common issues in meta-analysis that must be considered when interpreting results.
The EDQM runs a quality evaluation programme for active ingredients and excipients used in the manufacture of medicines. The Certification of Suitability [ 18 ] to the Monographs of the European Pharmacopoeia procedure was initially set up in 1992 as a pilot programme but went on to become routine for chemical substances in 1994; it was ...
This directive provides guidelines for ensuring the highest standards of quality and integrity in clinical research. In the European Union, a parallel guideline exists for clinical trials involving medical devices. This guideline is known as the international standard ISO 14155, and it serves as a harmonized standard within the European Union ...
The European Medicines Agency (EMA) operates as a decentralised scientific agency (as opposed to a regulatory authority) of the European Union (EU) and its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. [8]
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.
Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [1] The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered.
TMFs are a collection of documents and other artifacts which "individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory ...
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]