REGULATORY AFFAIRS
Course Length : Regular - 90 Days, Fastrack - 45 Days
Course Start : For Details Call +91 9247716307,
Limited seats per batch
Course Location : Hyderabad, India
Contact Us : Call +91 9247716307
 

Syllabus

 
  • 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
    a) Regulatory submissions to Regulated countries like EU, US
    b) Regulatory submissions to Semi-Regulated countries
    c) Regulatory submissions to Non-Regulated countries
    d) 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
 

Overview

 
A regulatory affairs (RA), also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory affairs Ensuring that their companies comply with all of the regulations and laws pertaining to their business.

Working with federal, state, and local regulatory agencies and personnel on specific issues affecting their business. i.e. working with such agencies as the Food and Drug Administration or European Medicines Agency (pharmaceuticals and medical devices); The Department of Energy; or the Securities and Exchange Commission (banking).
 

Eligibility

 
  • Ph.Ds in any science discipline
  • Postgraduates with specialization in any of the areas of molecular biology, genetics, microbiology, structural biology, genetics, chemistry, physics, statistics and biotechnology.
  • B. Pharm, M. Pharm, MBBS, MD, BE/B. Tech, ME/M.Tech etc.
  • Final year students of the above courses as a part of fulfilling their project work.
  • Students looking for Research opportunities abroad.
  • Research Scholars in any areas of life & chemical sciences.
  • Bachelors in Biotechnology, Microbiology, Bioinformatics, Life sciences, Biochemistry, Zoology, Botany and related discipline.
 

Course Goal


This course provide you with practical information on effective drug registration processes; best practices for integrating regulatory requirements from early stages of development; advice on how to develop RA project teams and strategies that work for both you and the regulators.

 Job opportunities:
Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:
  • Pharmaceuticals
  • Medical devices
  • Invitro diagnostics
  • Biologics and biotechnology
  • Nutritional products
  • Cosmetics
  • Veterinary products
 
 
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