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BUS I Knew S AN RAM SM M A C NA R NT OG AG E M E GR A D UAT E P Saunas 2009 Project Managers Institute June 2224, 2009 Tempe, Ariz. Experienced SMA CNA Contractors know that their best project managers
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RAM SM - PINP stands for Risk Assessment and Mitigation Strategies - Postmarket Implementation Plan. It is a document submitted to the FDA by pharmaceutical companies to outline the measures they will take to mitigate specific risks associated with their drugs.
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Pharmaceutical companies that have been required by the FDA to implement Risk Evaluation and Mitigation Strategies (REMS) for their drugs are required to file RAM SM - PINP.
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RAM SM - PINP should be filled out according to the FDA guidelines, including detailed information on the specific risks being addressed, the proposed mitigation strategies, timelines for implementation, and monitoring plans.
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The purpose of RAM SM - PINP is to ensure that pharmaceutical companies proactively address and mitigate specific risks associated with their drugs to protect public health.
What information must be reported on ram sm - pinp?
RAM SM - PINP must include information on the specific risks being addressed, proposed mitigation strategies, timelines for implementation, monitoring plans, and any additional information requested by the FDA.
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