Course in Drug Regulatory Affairs
General overview of Pharmaceutical Industry
Introduction to RA profession
ICH guidelines overview
ICH Quality guidelines - Q1, Q2, Q3, Q6 and Q7.
Types of Drug Applications
a) DMF (Types)
b) ASMF
c) IND
d) NDA
e) ANDA
Regulatory Authorities and their submissions
Ø Regulatory submissions to Regulated countries like EU, US
Ø Regulatory submissions to Semi-Regulated countries
Ø Regulatory submissions to Non-Regulated countries
Ø Indian Regulatory submission
Preparation of Drug Applications (Dossiers) in Different formats
a) CTD
b) ACTD
Importance of stability studies while submitting dossiers
Handling deficiencies from Drug Regulatory Authorities
Bioavailability and Bioequivalence studies (BA & BE)
Preparing the student for regulatory Interview
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