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Get Name Of National Regulatory Authority Procedure ... - Who

Rial applications for vaccines and Biologicals Guidelines for the Review & Evaluation Process of Applications for Clinical Trials of Vaccines & Biological medicines National Regulatory Authority of Country CONTENTS 1 Introduction 2 Definition of Terms and Abbreviations Check-list for documents in an Application 3 Procedures for Application submission and review 4 Institutional Review Board and/or Independent Ethics Committee 5 Amendments to Trial Protocol 6 Regulatory Authority Inspections 7 R.

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