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P.D.E.As Prof Ramkrishna More Arts,Commerce and Science College,Akurdi Pune44Introduction to Cyber Security Practice MCQ Questions with SolutionsModule 4: System and Application Security 1. When an
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What is module 4 system and?
The Module 4 system refers to a specific part of regulatory reporting that focuses on the submission of information regarding safety and efficacy data for products, typically related to pharmaceuticals and medical devices.
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Manufacturers and sponsors of pharmaceuticals and medical devices are required to file Module 4 system data as part of the regulatory submissions to health authorities.
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To fill out Module 4, one must gather necessary clinical study data, organize the information according to the required format stipulated by regulatory bodies, and ensure compliance with the specific guidelines.
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The purpose of Module 4 is to provide comprehensive data on clinical studies to demonstrate the safety and efficacy of a product prior to approval.
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Information that must be reported includes details of clinical studies, study design, study results, adverse event data, and laboratory findings.
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