The term “human trafficking” typically triggers images of children and women being coerced, bought and sold into lives of sexual slavery. Tragically, that picture is true; and just as tragically, it is incomplete. The International Labor Organization estimates as many as 21 million people are victims of human trafficking, forced labor and slavery. Men, women [...]
Posted on 20. Jun, 2016 by Karl Kapp.
The math is simple if not scary; the number of hospital mergers increased 18 percent over last year and, in general, when a single hospital has a monopoly, the prices are 15 percent higher than in areas with four or more competitors. Finally, this has increased the average in-patient stay in those places by almost [...]
Given the number and complexity of regulatory requirements facing compliance officers of global Life Sciences companies, compliance officers could be excused for not looking outside the industry to track regulatory developments not specific to the life sciences industry. Because regulatory and enforcement trends may be evident first in other industries, compliance professionals with the resources [...]
Posted on 15. Jun, 2016 by Karl Kapp.
To create a culture of continual learning in an EHS organization, three key elements need to be in place. If these elements are in place, it becomes easier and more effective to sustain a learning culture and to continually improve. 1) Treat learning as a valuable activity. Too often learning about EHS topics is treated [...]
Posted on 13. Jun, 2016 by Rob Sims.
Last week I attended the ISPE/FDA/PQRI Quality Manufacturing Conference in Bethesda, MD, USA, and attended the ISPE Quality Metrics working group session. Some background: ISPE has really taken a leadership effort to collecting and sharing meaningful feedback to FDA regarding CDER’s Quality Metrics initiative. The session on “Quality Culture” was especially enlightening. The event featured [...]
On March 8, 2016 the US Food and Drug Administration (FDA) entered into a settlement agreement with Ireland-based Amarin Pharma, Inc., about the company’s off-label marketing of its drug Vascepa®.The settlement followed a decision by US District Judge Paul Engelmayer who ruled that Amarin could promote Vascepa beyond the narrow uses approved by the FDA [...]
EvGen is the shortened version of evidence generation. And EvGen is becoming a hot topic. The concept of EvGen is that the life sciences industry and others need to provide evidence of medical results in such a way that researchers will be able to distill the data into actionable evidence that can ultimately guide clinical, [...]
Because equipment for measurement, control, and laboratory use is crucial to the quality and consistency of medical products, IEC 61010 exists to ensure that this equipment meets certain standards. The International Electrotechnical Commission (IEC) published the third edition of the IEC 61010-1 standard in June 2010. IEC 61010 requires that equipment be accompanied by certain [...]
An interesting blog article titled, What We Mean When We Talk About EvGen Part I: Laying the Foundation for a National System for Evidence Generation is the first in a series of blog entries on the FDA Voice blog which explores the idea of what is being called evidence generation or “EvGen.” The blog article [...]