How is the ACCME participating in the data collection and auditing process for the ER/LA Opioid Analgesics REMS?

Published Date: 
October 29, 2013

As a service to the CME community and to the FDA, the ACCME has agreed to contribute to fulfilling the data collection and auditing requirements for the ER/LA Opioid Analgesics REMS. The ACCME has modified its Program and Activity Reporting System (PARS) to enable accredited providers to submit information about REMS CME activities and has a process for generating reports containing data about those activities. The ACCME believes that these modifications will offer accredited CME providers within the ACCME system a streamlined, efficient, and effective process for submitting data about REMS-compliant activities.

The ACCME has also agreed to conduct independent audits of at least 10 percent of RPC-funded, REMS-compliant activities.  Each audit will include a review of whether the content of the activity complied with the requirements outlined in the FDA Blueprint, as well as with the ACCME’s Standards for Commercial Support. 

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