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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]
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.
September 1, 1996 - Standards Malaysia officially started its operation at 21st Floor, Wisma MBSA, Shah Alam, Selangor. September 3, 2001 - Standards Malaysia moved its operations from Shah Alam to the Federal Government Administrative Centre in Putrajaya. 2008 - Standards Malaysia moved its operation to Century Square, Cyberjaya.
Courses last five or six years. Two years of pre-clinical training in an academic environment and three years clinical training at a teaching hospital. [6] The medical program is usually divided into three phases. Phase 1 consists of the first two years of the programme involving integrated teaching and learning of the relevant basic medical ...
Medical training takes usually 5 years. Newly graduated doctors are required to perform at least 4 years, including 2 years of housemanship (internship before becoming a fully qualified general practitioner) and 2 years compulsory government service, in public hospitals throughout the nation, thus ensuring adequate coverage of medical needs for ...
Meet the clinical and communication skills requirements (see section) [7] Medical education credential requirements: A medical diploma of medical education taken at an institution registered in the World Directory of Medical Schools (WDOM). The official source to confirm that a medical school meets ECFMG's requirements, is the World Directory ...
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