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This SOP outlines the procedures for monitoring study sites post-approval to ensure compliance with ethical standards in research conducted by ERC, BBS in Bangladesh.
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What is sop 10 post approval?
SOP 10 Post Approval refers to a set of procedures and documentation required by regulatory bodies after a product has received approval for marketing to ensure ongoing compliance.
Who is required to file sop 10 post approval?
Individuals or companies that have received approval for a product from regulatory authorities, such as manufacturers or marketers, are required to file SOP 10 Post Approval.
How to fill out sop 10 post approval?
To fill out SOP 10 Post Approval, entities must complete the provided forms with accurate information regarding the product, ensure all necessary documentation is included, and submit it to the appropriate regulatory authority.
What is the purpose of sop 10 post approval?
The purpose of SOP 10 Post Approval is to monitor and ensure that approved products continue to meet safety and efficacy standards after they are brought to market.
What information must be reported on sop 10 post approval?
Information that must be reported includes product performance data, adverse event reports, changes in manufacturing processes, and any other information pertinent to the continued safety and effectiveness of the product.
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