ICH E8

ICH E8 Section 4 – Drug Development Planning

This course dives into Section 4 of ICH E8: Drug Development Planning. We’ll explore the key principles for designing and developing drugs, including drug manufacturing, non-clinical (animal) studies, general human study design, and research. We’ll examine the rigorous testing process, international guidelines, and ethical considerations involved in bringing new medications to patients.

CEU Credits: 0.1

Course Code: ELM-929

Duration: 15 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: v1.0

Effective Date: 05/17/2024

Curriculum for this course

Welcome

Introduction

Drug Development Process

Quality Considerations for IMP Development

Drug Development Phases

Types and Phases

Non-Clinical Trials

Clinical Studies

Phase 1: Clinical Pharmaceuticals

Phase 2: Therapeutic Exploratory Studies

Phase 3: Confirmatory Studies

Phase 4: Post-Approval Studies

Name That Phase!

Name That Phase Results

Other IMP Considerations

Special Populations

Additional Development

Conclusion

Summary

Test your Knowledge!

Revision History

v1.0 - Course Released on 10/29/2024

Author

Nick Cohen

GxP Quality Assurance Expert

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.