About the Course
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Refresher Course on New Drugs and Clinical Trials Rules 2019 13 to 17 March 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
Dr Bhatt-CDSCO-ECRole-14Mar23
Various Committees and there roles in New Drugs Approval Process
Emerging Issues in Clinincal Bioresearch Monitoring
Evaluation of CMC data
Clinical Data Evaluation for marketing authorization of new drugs
Post-marketing surveillance and its monitoring
Introduction to GCP, Conduct of GCP inspections and findings
Pharmacovigilance programme in India
Detection of Data Integrity and Forensic Evaluation of Electronic data
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