Ads
related to: gmc good clinical practice
Search results
Results from the WOW.Com Content Network
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]
The main guidance that the GMC provides for doctors is called Good Medical Practice. [21] This outlines the standard of professional conduct that the public expects from its doctors and provides principles that underpin the GMC's fitness-to-practise decisions.
The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
The British Journal of General Practice (BJGP) is an international journal publishing research, debate and analysis, and clinical guidance for family practitioners and primary care researchers worldwide, formerly known as The Journal of the Royal College of General Practitioners [17]
Events triggering a SEA can be diverse, include both adverse and critical events, as well as good practice, and are a structured way of reviewing an occurrence that caused harm, a near miss or an identified risk, or a reason for celebration. With the aim of being a positive development, it can cover clinical as well as administrative areas. [3 ...
The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
Owing to the importance of the IB in maintaining the safety of human subjects in clinical trials, and as part of their guidance on good clinical practice (GCP), the U.S. Food and Drug Administration (FDA) has written regulatory codes and guidances for authoring the IB, and the International Conference on Harmonisation (ICH) has prepared a ...
Ads
related to: gmc good clinical practice