Advanced Program in Regulatory Affairs

Advanced Program in <strong> Regulatory Affairs</strong>

7 May 2020

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8 Weeks 60 Hrs Placement Support

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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