Purple Book Used in the Pharmaceutical Landscape
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LevelIntermediate
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Total Enrolled65
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Duration22 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
Description
Explore the intricate realm of biological products through Pharmastate Academy’s comprehensive Purple Book course. Uncover the FDA’s Purple Book significance in ensuring patient safety, regulatory compliance, and risk mitigation, shaping market dynamics for fair competition and potential healthcare cost reduction. Delve into Purple Book limitations, addressing challenges like information delays and coverage gaps. Discover its applications in regulatory submissions, market analysis, empowering healthcare professionals, researchers, and policymakers. Trace its origin from the Biologics Price Competition and Innovation Act, anticipating future trends like real-time updates and enhanced accessibility. Study the Purple Book’s structured format, revealing product listings, categories, license, and manufacturer details. Understand comprehensive product overviews with standardized nomenclature, license numbers, and approval dates. Immerse in the biologicals and biosimilars landscape, differentiating their approval pathways, manufacturing processes, and cost implications. Explore interchangeable biological products and their role in competition and cost reduction. Learn to navigate the Purple Book online, gaining insights into access, user registration, search tools, and customization. Engage in real-world case studies showcasing the Purple Book’s impact on regulatory compliance, market entry, healthcare decisions, and competitive analysis. Enroll in Pharmastate Academy’s Purple Book course for insights into this indispensable pharmaceutical resource.
What I will learn?
- Importance and Limitations of the Purple Book.
- Historical Development of the Purple Book - Origin, Evolution, and Future Trends of the Purple Book.
- Structure of the Purple Book - Content, Elements & Format of the Orange Book.
- Biologicals, Biosimilars & Interchangeable Products.
- Navigation Process within the Purple Book.
- Real-life case studies of Purple Book utilization.
Course Curriculum
1. Purple Book Used in the Pharmaceutical Landscape
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1.1 Objectives
04:35 -
Quiz: Objectives
2. Historical Development
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2.1 Historical Development
03:22 -
Quiz: Historical Development
3. Structure of Purple Book
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3.1 Structure of Purple Book
03:21 -
Quiz: Structure of Purple Book
4. Biologicals & Biosimilars
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4.1 Biologicals & Biosimilars
03:40 -
Quiz: Biologicals & Biosimilars
5. Understanding Navigation Process
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5.1 Understanding Navigation Process
02:50 -
Quiz: Understanding Navigation Process
6. Case Studies
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6.1 Case Studies
04:32 -
Quiz: Case Studies
7. Final Assessments
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Quiz:
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Course Ratings & Reviews
Very informative
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LevelIntermediate
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Total Enrolled65
-
Duration22 minutes
-
Enrollment validityEnrollment validity: 30 days
-
CertificateCertificate of completion
Material Includes
- 6 Learning Videos
- 7 Quizzes
- Course Certificate
Target Audience
- Pharma professionals from manufacturing
- QA, QC, and regulatory Affairs
- Students pursuing D.Pharm, B.Pharm
- M.Pharm, Ph.D, & Pharm D.
Educators
Course Ratings & Reviews
Very informative