The more things change, the more they stay the same. Three years ago, I wrote a column for the Clinical Researcher titled “Global Regulatory Insights: Why Do We Have Regulatory Compliance Professionals?” Three years later, the U.S. Food and Drug Administration (FDA) has become more open and communicative, and regulatory bodies are acknowledging that change […]
As a former volunteer and now the newly appointed Workforce Innovation Officer, I am pleased to continue to support ACRP’s ongoing efforts to further enhance the quality and competency of the clinical research workforce. From informal activities to formal, industry-wide programs, ACRP is involved in a wide variety of initiatives about which I will be […]
“Quality” is a term that is thrown around at will when speaking about clinical research—we speak of quality by design, quality systems, quality endpoints, quality management plans, quality data, quality outcomes, etc. We have been talking about quality for as long as I have been involved in clinical research, and that has been for more […]
The new European Medical Device Regulation 2017/745 (MDR)1 and the European Union (EU) In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR)2 passed in the European Parliament on April 5, 2017. The MDR was published in the Official Journal of the European Union on May 5, 2017, and entered into force on May 25, 2017.
At PRA, “remote” doesn’t mean alone. We’re a global organization of more than 13,000 people. Many employees work in our offices around the world, but many others make up a special group – our remote employees. For some people, the thought of being a remote employee is daunting. It’s easy to feel isolated and not […]