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Regulatory affairs

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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
Intellectual Property and Patents rights (IPPR)
Module 1
  • Introduction to Intellectual Property (IP)
  • Patents
  • Trademarks
  • Copyrights
  • Basic concepts of patent law-India, United States and European Union
  • Patent Cooperation Treaty
  • Patent Specifications
  • Terms and terminology
Intellectual Property and Patents rights (IPPR)
Module 1
  • Introduction to Intellectual Property (IP)
  • Patents
  • Trademarks
  • Copyrights
  • Basic concepts of patent law-India, United States and European Union
  • Patent Cooperation Treaty
  • Patent Specifications
  • Terms and terminology
Intellectual Property and Patents rights (IPPR)
Module 1
  • Introduction to Intellectual Property (IP)
  • Patents
  • Trademarks
  • Copyrights
  • Basic concepts of patent law-India, United States and European Union
  • Patent Cooperation Treaty
  • Patent Specifications
  • Terms and terminology
Module 2
  • Basic Patent Law and concept
  • Structure of patent
  • Patent searching
  • Indian Patent Office (IPO)
  • United States Patent and Trademark Office (USPTO)
  • European Patent Office (EPO)
  • Delphion and Thomson Reuters
  • Tools of patent searching
  • Keyword searching
  • Boolean searching
  • Query searching
  • Image searching
  • Chemical structure searching
  • Citation searching
  • Cluster searching
  • Classification code searching
Module 3
  • Patent Analysis
  • This module will cover various types of patent searches
  • Prior Art Search
  • Validity Search
  • Infringement Search
  • Freedom to operate search
  • Patentability search
  • Novelty search
  • Technology landscaping
  • State of art search
  • Maps portraying an overall composition of a technology field or an expanse of a technology field
  • Map portraying expanses of application of a technology field
  • Map portraying a technology fields related to a technology field
  • Map portraying a technological progress
  • Map portraying changes of relations between activity of a technology developmetn and participating companies
  • May portraying changes of technical contents
  • Map portraying trends of problems in a technological development
  • Map portraying changes of influential industrial field in technological development
  • Map portraying the status quo of applications with multiple perspective of a technology field
  • Maps portraying problems in a technological development
  • Map portraying correspondence between problems and technologies
  • Map portraying applications having filed many applications
  • Map portraying structural differences applications among the US, Europe and Japan
  • Map portraying upper ranked applicants (right holders) of foreign countries
  • Map portraying expanses of a technology development in foreign countries
Need Help?
  • 04066844855

    09989330160

  • Email: writeus@syntenylifesciences.com

  • Windsor Plaza, Vegitable Market Road, New Nallakunta Center,Hyderabad.

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Many students and entrepreneurs often restrict themselves in learning and at the same time mastering a specialised area of biological studies rather than taking up the holistic study of complete life sciences.

Contact Us
  • Windsor Plaza, Vegitable Market Road, New Nallakunta Center,Hyderabad.

  • Email: writeus@syntenylifesciences.com

  • 04066844855

    09989330160

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