Regulatory Affairs Training Course

The Training Modules are

⦁ Introduction to Regulatory Affairs
⦁ Overview of the Regulatory Environment
⦁ Importance and Role of Regulatory Affairs in Pharma and Biotech
⦁ Regulatory Bodies: FDA (USA), EMA (Europe), CDSCO (India), TGA (Australia), etc.

⦁ Drug Development and Approval Process
⦁ Preclinical and Clinical Trial Phases (I-IV)
⦁ IND, NDA, ANDA, BLA – Application Procedures
⦁ Clinical Trial Protocol and Good Clinical Practices (GCP)

⦁ Regulatory Documentation and Submission
⦁ Common Technical Document (CTD/eCTD)
⦁ Dossier Preparation for Global Submissions
⦁ Regulatory Writing: Investigator Brochure, Package Inserts, Labels

⦁ Global Regulatory Guidelines
⦁ ICH Guidelines (Q, S, E, M series)
⦁ FDA Guidelines and CFR
⦁ EMA and WHO Requirements

⦁ Regulatory for Biologics, Vaccines & Medical Devices
⦁ Regulatory Pathways for Biologics
⦁ Device Classification and Approval (510(k), PMA)
⦁ Combination Products

⦁ Post-Approval and Lifecycle Management
⦁ Pharmacovigilance and Risk Management Plans
⦁ Post-Marketing Surveillance
⦁ Product Labeling Changes, Renewals & Variations

⦁ Regulatory Compliance and Quality Assurance
⦁ GMP, GLP, GDP Overview
⦁ Inspection Readiness and Audit Handling
⦁ CAPA and Change Control

⦁ Regional Regulatory Affairs
⦁ US FDA Submissions and Interactions
⦁ EMA & European Regulatory Requirements
⦁ India (CDSCO), ASEAN, Japan (PMDA), and China (NMPA)

⦁ Ethics, Legal and Professional Aspects
⦁ Regulatory Ethics
⦁ Intellectual Property and Patent Basics
⦁ Communication and Liaison with Regulatory Authorities

⦁ Project Work / Case Studies
⦁ Real-world Regulatory Case Studies
⦁ Simulated Regulatory Dossier Submission