Risk Evaluation & Mitigation Strategies Summit 26th and 27th January
We will be attending the 9th Risk Evaluation & Mitigation Strategies Summit in Arlington, Virginia on the 26th and 27th of this month, the same week President Trump will be sworn into office, so it should be an exciting time to be in Washington!
REMS 2017 will feature over thirty speakers from industry, patient advocacy organisations, academia, and healthcare providers and consultancies. Professor Mike Wolf, one of our own academic advisors from Northwestern, Chicago will be presenting. We look forward to learning more about developing patient-centered practises in risk mitigation to ensure compliance and to increase patient safety.
A Risk Evaluation and Mitigation Strategy (REMS) is a special program required by the US Food and Drugs Administration (FDA). This ensures that the benefits of prescription drugs outweigh their risks, similar to the Risk Management Plan (RMP) in the EU.
According to the FDA, a REMS is required as part of the approval of a new product, or for an approved product when new safety information arises.
The US authorities are currently exploring new avenues with the specific aim of helping to inform patients about high risk medicines, a topic which our co-founder and academic advisor Professor Theo Raynor and his colleagues have been researching for a number of years.
Theo was in Washington DC autumn 2015, as the only expert invited from outside North America to provide input to a closed meeting of the FDA. The meeting took place under the auspices of the prestigious Brookings Institution, close to the White House in Washington DC and one of the world’s most influential think-tanks.
Theo was able to draw on his expertise and experience at Luto when discussing previous research which explored the likelihood of harm from a medicine, and how this informs best practice in contemporary health communication.
At Luto, we can help pharmaceutical companies modify and improve their communications via testing for existing and future REMS products. For more information about your REMS or RMP plans, please contact us in the US office at Chicago +1 708 406 6531 or the UK office at +44 (0) 113 384 5882.