Drug Regulatory Affairs

Class 1: Introduction, Definition, Rationale, Roles and responsibilities

Class 2: How RA works in pharma, Regulatory Authorities, Innovator & Generic Drugs, Drug development

Class 3: Different guidelines used in Regulatory work

Class 4: ICH Guidelines — Quality in depth; Safety, Efficacy, Multidisciplinary overview

Class 5: CTD Structure — Module-wise content detailing

Class 6: ACTD Structure; Difference between CTD and ACTD

Class 7: Dossier filing — Europe, USA and Rest of World

Class 8: Documents required for Dossier preparation

Class 9: Post approval — Variations and Renewals

Class 10: Overview of medical device regulatory

Class 11: Clinical Trials, phases, Pharmacovigilance, PSUR

Class 12: Frequently asked interview questions with answers