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Course Modules For Pharma Regulatory Affairs
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Module |
| 1. |
Pharma Regulatory Regime in USA, EU and India
- Pharmaceutical Legislation
- Regulatory Bodies
- Import of Drugs in USA
- Export of Drugs from USA
- Licensing in Europe
- Regulations of Export and Manufacture of Drugs in India
- Pharmacovigilance
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2.
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Introduction to Pharmaceutics
- Introduction to Pharmaceutical drugs and Products
- Classification
- Testing
- Introduction to Pharmaceutical Chemistry
- Industrial Application
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| 3. |
Pharma Regulation Practices and Procedure
- Pharma Regulatory Affairs
- Drug Regulatory Authorities
- Good Manufacturing Practices
- Regulations of Pharmaceutical products
- Regulations of Alternative Systems of Medicine
- Bioethics
- Drug Policy in India
- Regulatory profession
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| 4. |
Good Manufacturing Practices, Quality Assurance and Regulation
- Introduction
- Overview of Good Manufacturing
- Practices
- International GMP Regulation
- Indian GMP Regulation
- Quality Assurance
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| 5. |
Regulatory Compliance for Pharma and Biotech Products
- Regulatory Compliance in USA
- Orphan Drugs
- Regulatory Compliance in India and Other Countries
- Drugs and Magic Pharmaceuticals Production in Transgenic Animals
- Future of Compliance-an efficient and effective Commercial Operation
- Strengthening Governance and Regulatory Compliance
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