Regulatory Affairs courses in hyderabad - Hyderabad

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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