Thomas Doherty | Intelligent Hospital Systems
The passage last year of federal legislation to regulate pharmacy compounding was not only necessary but long overdue. Compounding pharmacies had historically been regulated at the state level, even though some produced drugs that were being sold in other states. Meanwhile, the public remained largely unaware of the compounding industry, confident that their health care providers would never inject them with anything that was not safe.
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In The Headlines
Daniel Draz | Fraud Solutions
Monday Morning Quarterbacking
On Monday mornings during pro football season in offices around the country, win or lose, there’s the inevitable water cooler discussion about the team’s performance and what they should have done during the game in critical situations. The discussion, or post game review, is generally referred to as “Monday morning quarterbacking” and is analogous to the kind of after the fact analysis that occurs in a highly regulated industry.
In the business environment, this kind of hindsight, and post event regulatory scrutiny, heightens the need for effective governance, risk and compliance (GRC) programs as “getting it wrong” often comes with penalties, fines and sanctions. Everything companies do on the global playing field is viewed microscopically by regulators in the unique position to assess day to day operational performance after the fact.
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Topic of Discussion
Michael Abrams | Numerof & Associates, Inc.
Expanding government and payer requirements for additional data on products, whether for safety monitoring, efficacy confirmation or economic and clinical value evaluation, underscore the importance of an integrated strategy for investigator initiated trials (IIT) and real world evidence (RWE) research. In developing an IIT/RWE strategy, companies need to be clear up front about why specific research should be supported, and use this criteria to decide which studies have the potential to be valuable. Determining how and where to use IITs and RWE requires clear objectives for the research and coordinated organizational capabilities.
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