If folks in your marketing department seem unduly cheerful despite the end of summer, they may be experiencing a case of Amarin-induced euphoria. But, while your colleagues are feeling euphoric, you, as a compliance professional, may now feel acute off-label promotion anxiety. What may the future hold in a post-Amarin world?
Continue reading "Amarin v. FDA: Predicting the Future of Off-Label Promotion"
In The Headlines
October 9, 2015
Abraham Gutman | AG Mednet
Abraham Gutman | AG Mednet
It has been said for many years that philosophy and ethics need to keep up with technological progress else we will release advances that may hurt us rather than help us. Some have gone as far as saying that technological advancement should follow philosophy and ethics since this is the safest course to avoid possible mistakes. I can’t help but think of regulatory compliance in this context: How can we ensure that as advanced data-gathering technologies come to market, the lag in compliance regulations doesn’t slow down our ability to benefit from them?
Continue reading "Predictions for Pharmaceutical Compliance: Will They Come True?"
Topic of Discussion
CEOs help organizations establish the tone at the top for the role of compliance at drug and medical device companies. Traditionally, that tone has been one of mixed messages in the life sciences industry.
It’s understandable. CEOs at major life sciences companies mostly come from the ranks of clinicians, engineers, marketers or finance executives. The top job is rarely given to someone from compliance, unless the board feels a need to address regulatory issues.
Continue reading "CEOs and Pharma Compliance: Tone is Set at the Top"
A UL EduNeering Sponsored Article
The whitepaper for this article is available for free download here: “Top Seven Risks to Consider When Selecting a Life Science LMS”.
Scott Barnard | UL EduNeering/UL Life & Health
Life Science companies operate in a highly regulated industry. With risk mitigation core to their DNA, they must be careful when evaluating an enterprise Learning Management System (LMS) or a Talent Management System (TMS) used in GxP areas. It is critical that these systems meet data integrity standards and are validated against the stringent requirements of 21 CFR Part 11 and EU Annex 11.
We find that, as companies look to harmonize systems and bring in enterprise applications to manage both employee development and qualification training, these projects are increasingly influenced or guided by IT and HR. Since these organizations are not as versed in US and international regulatory requirements and since their training programs do not require a validated platform, the project teams they lead are bringing in vendors and systems that do not support the GxP requirements of their organization. This is putting a lot of pressure on QA to “relax” their standard of validation, putting their organization at a data integrity risk.
Continue Reading: “Performance Gaps in LMS Functionality May Lead to Critical Risk for Life Science Companies.”