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Some of the special requirements for Internet CME were eliminated as part of the February 2014 changes to simplify the accreditation requirements and process. The requirements that support the Standards...
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Some of the special requirements for enduring materials were eliminated as part of the February 2014 changes to simplify the accreditation requirements and process. The requirements that support content validity...
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Yes. Providers may choose any quality assurance method that works for them in order to ensure that their regularly scheduled series (RSS), and all their activities, are planned and presented...
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No. There are no special requirements for regularly scheduled series (RSS). For RSS, as with any activity type, providers are expected to demonstrate compliance with all applicable ACCME accreditation requirements...
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No. Organizations applying for Provisional Accreditation are not required to have an on-site survey. Surveys are required; conference calls are the standard interview format the ACCME currently uses. Initial applicants...
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CME providers have the option of using the Performance-In-Practice Structured Abstract or to continue using labeled evidence to verify performance-in-practice. The ACCME Structured Abstract is intended to simplify, clarify and make...
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The ACCME expects accredited providers to discontinue the use of the term “sponsor” (e.g., jointly sponsored, joint sponsorship, directly sponsored, direct sponsorship) for new materials published after January 1, 2015....
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Yes. The February 2014 changes to ACCME’s accreditation requirements and processes apply to all accredited providers within the ACCME accreditation system. ACCME Recognized Accreditors are responsible for implementing these changes...
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Accredited CME providers that are interested in conducting the long-term evaluations might provide service in support of the ER/LA Opioid Analgesics REMS in the following ways: Providers can conduct the long-term...
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The RPC has hired inVentiv Health, Ltd. to manage the commercial support. So, in this complicated case, for simplicity, the accreditor is allowing providers to specify the “RPC/inVentiv Health, Ltd.” as...
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CME in Support of REMS: This ACCME Web Page provides updates and resources for accredited CME providers that choose to design education to fulfill the REMS goals. FDA Risk Evaluation and...
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The FDA has provided the following description of the REMS Long-Term Evaluations in its ER/LA Opioid Analgesics REMS Supporting Document: “A subset of CE providers capable of conducting evaluations of long-term...
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The REMS Program Companies (RPC) are responsible to the FDA for fulfilling the requirements for long-term evaluations.  The RPC will provide funding to organizations that will conduct the long-term evaluations...
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The FDA has required long-term evaluations of the ER/LA prescribers who complete REMS-compliant CE activities. Specifically, the FDA is requiring the evaluation of knowledge retention and practice change in ER/LA...
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The CE community addresses prescription drug abuse in many ways. One way is by developing and presenting education that is explicitly part of the RPC-funded ER/LA Opioid Analgesics REMS that...
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REMS-related accredited CE activities meet some but not all of the requirements established by the FDA in its definition of a REMS-compliant CE activity.  
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For the ER/LA Opioid Analgesics REMS, the FDA writes that: “Training will be considered ‘REMS-compliant training’ under this REMS if: it, for training provided by CE providers is offered by an...
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The companies that have come together as a consortium of opioid manufacturers, the REMS Program Companies (RPC), are the entities responsible to the FDA.  
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According to the FDA, the goal of REMS is to ensure that the benefits of a drug or biological product outweigh its risks. The FDA may require a REMS as...
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The Food and Drug Administration Amendments Act of 2007 gave the FDA the authority to require manufacturers of drugs and biological products to put in place special programs if the...

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