OutcomesBy the end of the course, learners will be familiar with the following:
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Level: | Level 01 | ||
Duration: | 18 hrs. | |||
Pre-requisites: | NA | |||
What’s next: | Bio-pharmaceuticals Industry |
Lessons
Drug Life Cycle
- Pre-Clinical Phase: Drugs, Drug Types, Target Selection and Lead Discovery, Optimization and Modification
- Pre-Clinical Phase: Pre-Clinical Development
- Pre-Clinical Phase: Drug Patenting and IND
- Clinical Trials: Types of Clinical Trials
- Clinical Trials: Phases - I, II, III and IV
- Clinical Trials: Trial protocol
- Clinical Trials: New Drug Application and FDA Approval
- Post-Market Phase: Post-market studies
- Post-Market Phase: Entry of competitors, Patent expiry and entry of generics, and Patent extension
Regulatory Bodies and Associated Responsibilities
- History of Drug Regulations in the US
- Standards in Pharmaceuticals Industry
- Regulations in Pharmaceuticals Industry
- Regulations in other global regions apart from the US – Latin America, Canada, China, and Australia
- US Food and Drug Administration
- Enabling Rapid Availability of Drugs in Market
- Compliance regulation for protecting patient and physician data