About the Course
Earn a career certificate

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Refresher Course on New Drugs and Clinical Trials Rules 2019 13th to 17 th Marcch 2023
Overview of Clinical Trials - Regulations & Phases of ct
Clinical trial Design and method of randomization
Evaluation of Clinical Trial Data and Role of Biostatistician
Marketing Authorization Process of ND, IND, FDC and SND
IEC Registration & role of Ethics Committee
Emerging Issues in Clinincal Bioresearch Monitoring
Evaluation of CMC data
Post-marketing surveillance and its monitoring
Introduction to GCP, Conduct of GCP inspections and findings
Pharmacovigilance programme in India
Good Clinical Practices
SAE in Clinical Trials and reporting Causality
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Certificate
CDSCO Certificate
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