Advanced Program in Regulatory Affairs
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  • 7 May 2020

    Type: e-Learning

  • Filling Fast
  • Percentage Of Seats Remaining: 62% 62%
  • 8 Weeks
  • 60 Hrs
  • Placement Support


    Join our community of learners and elevate your career in clinical research.

    Course Brief

    This online program helps you to provide an overview on the general legal requirements to bring a pharmaceutical product to market –whether it is the creation of a new product, or import/export of a product to a new market – and maintaining it afterwards. To provide a sound knowledge and understanding of Global regulatory affairs. To create a thorough understanding of important regulatory concepts. Deliver innovative, breakthrough regulatory strategies for product development and registration.

    Advanced Program in Regulatory Affairs

    Duration: 2 Months

    Program Overview

    1. Regulatory Affairs Background: Introduction
    2. History of Regulatory Affairs
    3. Over view of Drug Development Procedures and Clinical Research
    4. Regulatory Filing Procedures in India
    5. Regulatory Filling Procedures in US
    6. Regulatory Filling Procedures In Europe
    7. Regulatory Filling Procedures For UK
    8. Marketing Authorization Application (MAA)
    9. Regulatory Filling Procedures For Canada
    10. Regulatory Filling Procedures For Australia
    11. Regulatory Procedures For Japan
    12. Submission of Global Documents
    13. Chemistry Manufacturing Control
    14. Global Harmonization Task Force (GHTF)/ International Medical Device Regulators Forum (IMDRF)
    15. Health Care Industry Intellectual Property Rights (IPR), Patents, Copyrights and Trademarks
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