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Good clinical practice training

Good clinical practice training is essential for anyone involved in testing medicines on human volunteers. Good Clinical Practice (GCP) is an ethical and practical standard for the protection of the welfare of all clinical study participants including the integrity of the data collected.
Who needs Good clinical practice training
All the personnel involved in any way during […]

By |January 16th, 2016|GCP|Comments Off on Good clinical practice training

Causes of FDA 483 warnings

FDA 438 warnings are dreaded by many companies as they affect reputation of those who are concerned. It begins with the issue of  FDA 483 form . This may be issued to inform the Principal Investigator or the institution of important unpleasant conditions observed during an FDA inspection. This letter can be issued for many […]

By |December 9th, 2015|GCP|Comments Off on Causes of FDA 483 warnings

Clinical Research

Clinical Research is an important professional discipline just as Regulatory Affairs. It deals with the art of designing experiments and carrying them out to determine if health products such as new drugs or medical devices are safe and effective for use in health care.

Regulatory professionals require a certain amount of knowledge in Clinical Research as […]

By |March 23rd, 2015|GCP|Comments Off on Clinical Research