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Protocol AMG NICOFACTCANo.: 15138 Principal Investigator Univ.Prof. Dr. med. Jr SchulzV03.4, 05.12.2018SiteEudraCT No.:Department of Neurology University Hospital Aachen201700216317A RANDOMIZED, DoubleClick,
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What is protocol amg?
Protocol AMG stands for Protocol for Approval of Marketing Authorization Applications for Gene, Cell, and Tissue Medicinal Products.
Who is required to file protocol amg?
Marketing Authorization Holders (MAHs) are required to file Protocol AMG with regulatory authorities.
How to fill out protocol amg?
Protocol AMG can be filled out by following the guidelines provided by regulatory authorities and by ensuring all required information is included.
What is the purpose of protocol amg?
The purpose of Protocol AMG is to provide a detailed plan for the pre-submission activities and assessment of marketing authorization applications for gene, cell, and tissue medicinal products.
What information must be reported on protocol amg?
Protocol AMG must include detailed information on the development plan, quality control methods, preclinical and clinical studies, risk management plan, and pharmacovigilance activities.
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