Stability: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team

The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) – A Pathway for Harmonization

Results from clinical laboratory measurement procedures must be equivalent to enable effective use of clinical guidelines for disease diagnosis and patient management. Analytical results that are harmonized and independent of the measurement system, time, and location of testing is essential for providing adequate patient care. The key to generating harmonized results is establishing traceabili...

Global Harmonization of Hemoglobin A1c

Measurement of glycohemoglobin (GHb) is widely used in patients with diabetes mellitus as a monitor of longterm glycemic control (1–3). In addition, prospective randomized clinical trials, most notably the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS), have demonstrated that GHb is a measure of the risk for the development of diabetes ...

Global harmonization--a catalyst for safety.

The majority of employers in the United States would not argue the point that the Hazard Communication Standard (HCS) has cost their company an incredible amount of time, money, and grief since its inception. Though it is a great concept, I question whether the HCS, even after more than 20 years in existence, has produced more than a few positive results in the eyes of most employers and employ...

Definition , Harmonization Cube Indicators & Good Practices

The need for global regulatory harmonization: A public health imperative.

DRUG REGULATION SERVES TO PROTECT PUBLIC HEALTH. DONE RIGHT, IT DRIVES THE ongoing assessment of product safety, efficacy, and quality and promotes the development and availability of new and better products. However, in our modern world, the mosaic of regulations that govern drug development and oversight nation by nation are creating unnecessary barriers to the efficient delivery of safe, inn...