Overview What is GxP? GxP refers collectively to several different types of “good practice” quality guidelines and regulations, each serving a specific purpose. In pharmaceutical product development, these include but are not limited to: GCP (Good Clinical Practice)GLP (Good Laboratory Practice)GMP (Good Manufacturing Practice) GxP standards broadly cover what are commonly referred to as the...
PHILADELPHIA, November 20, 2015 — Proposed updates to the International Conference for Harmonization Good Clinical Practice guidelines would be the most significant changes to international clinical research guidance in 20 years. What’s changing, and how will it affect you? Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will discuss proposed revisions to...
PHILADELPHIA, October 21, 2015 — Clinical research must produce consistent, reproducible results to be of real value. But too often, underlying decisions are based on opinions and not on well-defined, objective criteria, complicating things and making objectivity impossible. Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will address this issue at the...