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Regulatory Affairs Training



PSN Trainings is the Best Regulatory affairs Online/Classroom Training institute in Hyderabad,india


Regulatory Affairs Course Description


Introduction to Regulatory Affairs

  • What is Regulatory Affairs, Importance of RA department, Roles and their functions, Worldwide regulatory agencies and their roles

  • Notes on clinical trials, Drug development, Pre-formulation studies, API characterization, Generics, Innovator drugs, bio technology products and medical devices (CE marking)

  • ICH guidelines: Stability Testing of New Drug Substances and Products Stability Testing, Photo stability Testing of New Drug Substances and Products, Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Impurities in New Drug Substances, Impurities in New Drug Products, Impurities: Guideline for Residual Solvents, Pharmaceutical Development, carcinogenicity Studies, Genotoxicity Studies.

  • Introduction to Indian Pharma industry, Drug approval process in India, Regulations of Drugs and cosmetics Act, 1945.

  • USFDA Introduction, 21CFR, ANDA Regulatory Approval Process (US), Hatch-Waxman act, Patents and their types, GDUFA, Post approval changes (Annual reports, CB-30 and prior approval supplements), Types of DMF’s, Rules and guidelines.

  • Drug regulatory authorities in European Union (EU), different types of approval procedures (MRP, DCP, National and Centralized Procedures), brief study on post approval changes (variations and extensions), approval procedures for drug substance (DMF and CEP), rules and regulations.

  • Drug approval process in Australia, Canada, Japan and ROW markets.

  • Discussion in details on M4 Common Technical Document CTD (Module 1 to 5), eCTD submissions, NeeS format.

  • Hands on experience in CTD dossier compilation

  • Handling of responses, post inspection, audit queries, GMP, GLP trainings.

  • Resume preparation and mock up interviews



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