PhRMA has adjusted its Code on Interactions, partly in response to the Special Fraud Alert issued by the OIG.
Pro-ficiency is on a mission is to eliminate protocol deviations, one clinical study at a time. This mission is more important than ever, given the recent changes to the Code on Interactions with Health Care Professionals by the Pharmaceutical Research and Manufacturers of America (PhRMA). The update was announced on August 6, 2021, and will take effect on January 1, 2022.
The full Code on Interactions can be found here.
The update was partly released in response to a Special Fraud Alert issued by the Office of Inspector General (OIG) on November 16, 2020.
The full Special Fraud Alert issued by the OIG can be found here.
The OIG memo highlighted several key concerns including on-site meetings held at high-end resorts or hotels, expensive meals, and the overall medical value of meetings sponsored by members of PhRMA. Although, the industry has made many changes over the years regarding its interactions with HCPs the critical issue remains the same and that is providing important scientific or clinical information that an HCP can utilize in an unbiased and instructive manner.
Pro-ficiency’s virtual simulation technology can do just that – provide clinical instruction in a web-based solution that allows the user to learn at any time and at their own pace; thereby, ensuring that the information is retained and utilized to ultimately eliminate protocol deviations and improve overall understanding.
In addition to providing a training platform for clinical trials, the technology can also be easily used for presenting CME’s to HCPs in a remote, cost-effective, and accountable method that eliminates the risk of triggering any concerns associated with the revised PhRMA Code or the recent OIG Fraud Memo.
Reach out to Pro-ficiency to learn how we can help you eliminate protocol deviations and improve HCP training.
As Head of Regulatory Affairs and general council at Pro-ficiency, Margaret is committed to improving the clinical trial experience and bringing new solutions to market safely and ethically. With over 25 years of experience in the regulatory and legal fields of the life sciences, she has taken on the challenge of managing several trials across the globe throughout her impressive career. She brings this same dedication in developing new ideas and progressing clinical innovation at Pro-ficiency.