Preview Drug Regulatory Affair

Module1: Introduction to Drug regulatory affairs

Lecture 1. Introduction of Drug Regulatory Affair

Lecture 2.Role of Regulatory Affair

Lecture 3. Origin Regulatory Affair

Lecture 4. Goals of Regulatory Affair

Lecture 5. Importance of Regulatory Affair

Module2: Regulatory Authorities

Lecture 6. Drug Regulatory Authorities Across the World

Lecture 7. List of Document with Which Regulatory Affair Deals

Lecture 8. Applications Filed by Regulatory Affair

Lecture 9. Drug Approval Process

Module3: Regulatory Requirements in Pharmaceutical

Drug Product Lifecycle

Clinical Development

CTD and eCTD, NDA, Regulatory Compliance Activities, GLP, GCP, GMP, Pharmacovigilance

Class 3: Drug Regulatory Affair: 7th Dec

Module 4: Medical Device Regulation

Definition and Classification of Medical Devices

Steps in Medical Device Development, Product Lifecycle)

Product Lifecycle

Class 4: Drug Regulatory Affairs: 9th Dec

Module 5: Applicable ICH Guidelines in DRA

Q1A, Q1B, Q1C, Q1D, Q1E, Q1F, Q2, Q3, Q6, Q7

Class 5: Drug regulatory Affair: 11th Dec

Class 6: Drug Regulatory Affair: 15th Dec

Class 7: Drug Regulatory Affair: 16th Dec

Class 8: Drug Regulatory Affair: 18th Dec

Class 9: Drug Regulatory Affairs: 21st Dec

Class 10: DRA:23rd Dec

Class: Drug Regulatory Affairs: 2nd July

Assessment and Evaluation through MCQ test

Drug Regulatory Affairs