Advanced Program in Regulatory Affairs
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7 May 2020
Type: e-Learning
Filling Fast
- Percentage Of Seats Remaining: 62%
- 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
- Regulatory Affairs Background: Introduction
- History of Regulatory Affairs
- Over view of Drug Development Procedures and Clinical Research
- Regulatory Filing Procedures in India
- Regulatory Filling Procedures in US
- Regulatory Filling Procedures In Europe
- Regulatory Filling Procedures For UK
- Marketing Authorization Application (MAA)
- Regulatory Filling Procedures For Canada
- Regulatory Filling Procedures For Australia
- Regulatory Procedures For Japan
- Submission of Global Documents
- Chemistry Manufacturing Control
- Global Harmonization Task Force (GHTF)/ International Medical Device Regulators Forum (IMDRF)
- Health Care Industry Intellectual Property Rights (IPR), Patents, Copyrights and Trademarks
