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WHO/ROTA/DRAFT2/PC1/JULY 2023-Page 11 2WHO/ ROTA/DRAFT2/PC1/JULY 20233ENGLISH ONLY4 5 6Guidelines to assure the quality, safety and efficacy of live attenuated rotavirus vaccines (oral)7Proposed revision
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What is efficacy and safety of?
Efficacy and safety refer to the demonstrated ability of a product, often a drug or medical device, to produce a beneficial effect in treating a condition while not posing unacceptable risks to the patient.
Who is required to file efficacy and safety of?
Manufacturers and sponsors of clinical trials are required to file data on the efficacy and safety of their products with regulatory authorities.
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To fill out efficacy and safety submissions, one must compile clinical trial results, summarize methodology, report any adverse effects, and adhere to specific guidelines set by regulatory agencies.
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The purpose of filing efficacy and safety data is to ensure that products on the market are both effective for their intended use and safe for patients.
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Reported information must include clinical trial results, statistical analyses of efficacy, reported adverse events, and demographic data of trial participants.
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