NEWGeneral Considerations for Clinical Studies ICH E8 (R1)

سرفصل های دوره

Key Concept for ICH GCP E6 (R3) - Guideline on Best Practices to Design Quality into Clinical Studies

1 - Introduction

1 - Welcome and Objectives of the Course

2 - Purpose of ICH E8

3 - Link between ICH E8 and ICH GCP E6

2 - General Principles of Clinical Research

4 - ICH-GCP-R3-Overarching-Principles-Version-March-2021.pdf

4 - Protection of Clinical Study Participants

5 - Scientific Approach in Clinical Study

6 - FDA-Guidance-1-Collecting-Comprehensive-and-Representative-Input.pdf

6 - FDA-Guidance-2-Methods-to-Identify-What-is-Important-to-Patients.pdf

6 - FDA-Guidance-3-DRAFT-Selecting-Developing-or-Modifying-Fit-for-Purpose-Clinical-Outcomes-Assessments.pdf

6 - ICH-ReflectionPaper-PFDD-FinalRevisedPostConsultation-2021-0602.pdf

6 - ICH-ReflectionPaper-PFDD-OutcomeOfPublicConsutlation-2021-0527.pdf

6 - Patient Input into Drug Development

6 - ich-reflection-paper-proposed-ich-guideline-work-advance-patient-focused-drug-development-pfdd-en.pdf

3 - Process to Design Quality into Clinical Studies

7 - Strategy for implementing Quality by Design into Clinical Studies

8 - Considerations-in-Identifying-Critical-to-Quality-Factors-in-Clinical-Research.pdf

8 - Definition of Critical to Quality Factors

8 - Example-of-Factors-Principles-Document-CTTI.pdf

9 - Approach to Identifying Critical to Quality Factors

4 - Quality by Design Principles in Drug Development Planning

10 - General Principles of Drug Development Planning

11 - Quality of Investigational Medicinal Product

12 - Scope and Timing of Nonclinical Studies with respect to Clinical Studies

13 - Optimizing Clinical Development Planning

14 - Additional Development

15 - Conclusions and Ways to Move Forward

5 - Quality by Design Elements to Design Effectively Clinical Studies

16 - Background and Rationale

17 - Definition of Study Population

18 - Treatment Description

19 - Choice of Control Group

20 - Response Variables

21 - Methods to Reduce Bias

22 - Statistical Analysis

23 - Study Data

6 - Quality by Design Approaches during Study Conduct Safety Monitoring Reporting

24 - Study Conduct

25 - Safety Monitoring during Study Conduct

26 - Study Reporting

7 - Quality by Design in Practice Dos and Donts

27 - Case Studies and Assignment.html

27 - Case-studies-QbD.pdf

8 - Conclusion and Final Quiz

28 - Conclusion

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