Regulatory affairs

Regulatory affairs, Intellectual Property and Patent rights are some of the crucial components of biological research. The research could also involve an extensive evaluation of a particular drug formulations that could ensure protection of public health, promotion of the products, drug registration, marketing authority and also pharmacovigilance.

Course Goal

An aspirant would be able to have a comprehensive concepts on:

• Intellectual Property (IP) in general
• Industrial Property (Mostly patents) and copyright.
• Principles and legal rules of IP law
• Theoretical and practical connections between IP and academic/scientific works/studies

Curriculum for Regulatory Affairs and Intellectual Property & Patent Rights

Regulatory Affairs:

• Introduction to Regulatory Affairs
• International Council for Harmonization of Technical Requirements (ICH) overview
• ICH Guidelines: Q1, Q2, Q3 and Q 7

Types of Drug Applications

• DMF (Types)
• ASMF
• IND
• NDA
ANDA

Regulatory Authorities and their submissions

• Regulatory Submissions to regulated countries like European Union (EU), United States
• Regulatory Submissions to Semi-Regulated countries
• Regulatory Submissions to Non-Regulated countries
• Indian Regulatory Submission

Preparation of Drug Applications (Dossiers) in different formats:

• CTD
• ACTD
• Importance of stability studies while submitting dossiers
• Authorities (DRA)
• Bioavailability and Bioequivalence studies (BA & BE)
• Preparing the student for regulatory interview