ICH Guidelines in Pharmaceutical Landscape
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LevelAll Levels
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Total Enrolled67
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Duration56 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
Description
Pharmastate Academy offers a comprehensive course on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, essential for professionals in the pharmaceutical industry. Established in 1990, ICH aims to harmonize technical requirements for drug registration globally.
This course delves into ICH’s key components, including its Assembly, Management Committee, and Working Groups. We cover ICH guidelines across Quality, Safety, Efficacy, and Multidisciplinary areas, emphasizing their role in ensuring drug safety, efficacy, and quality. Topics include Quality Guidelines (e.g., stability testing and good manufacturing practices), Safety Guidelines (e.g., carcinogenicity and genotoxicity), Efficacy Guidelines (e.g., Good Clinical Practice), and Multidisciplinary Guidelines (e.g., medical terminology and electronic standards).
Learn how these guidelines streamline global regulatory processes, reduce duplication, and enhance public health through effective drug development and management. Perfect for regulatory affairs and pharmaceutical professionals seeking to align with international standards.
Join us to master the essential ICH guidelines and advance your career in the pharmaceutical industry.
What I will learn?
- Organizational structure of ICH.
- Key quality guidelines (Q1 to Q12).
- Key safety guidelines (S1 to S12).
- Key efficacy guidelines (E1 to E20).
- Key multidisciplinary guidelines (M1 to M11).
Course Curriculum
1. ICH Guidelines in Pharmaceutical Landscape
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1.1 Objectives
05:06 -
Quiz: Introduction
2. Structure & Objectives
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2.1 Structure & Objectives
05:31 -
Quiz: Structure and Objectives of ICH
3. ICH Quality Guidelines
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3.1 ICH Quality Guidelines
04:24 -
3.2 ICH Quality Guidelines
04:39 -
3.3 ICH Quality Guidelines
05:20 -
Quiz: Quality Guidelines
4. ICH Safety Guidelines
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4.1 ICH Safety Guidelines
05:54 -
Quiz: Safety Guidelines
5. ICH Efficacy Guidelines
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5.1 ICH Efficacy Guidelines
03:45 -
5.2 ICH Efficacy Guidelines
04:29 -
5.3 ICH Efficacy Guidelines
03:15 -
Quiz: Efficacy Guidelines
6. Multidisciplinary Guidelines
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6.1 Multidisciplinary Guidelines
05:13 -
Quiz: Multidisciplinary Guidelines
7. Implementation & Impact of ICH
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7.1 Implementation & Impact of ICH
05:12 -
Quiz: Implementation and Impact of ICH Guidelines
8. Case Studies
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8.1 Case Studies
03:02 -
Quiz: Case Studies and Real-World Applications
9. Final Assessment
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Quiz: Final
Earn this certificate!
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Course Ratings & Reviews
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LevelAll Levels
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Total Enrolled67
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Duration56 minutes
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Enrollment validityEnrollment validity: 30 days
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CertificateCertificate of completion
Material Includes
- 8 Learning Videos
- 9 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.