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.

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CEU Credits: 0.1
Course Code: ELM-929
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.1
Effective Date: 05/17/2024

Curriculum for this course

Introduction
Drug Development Process
Quality Considerations for IMP Development
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
Special Populations
Additional Development
Summary
Test your Knowledge!
v1.1 Minor update on 04/01/2025 to rewrite two quiz questions for clarity. Additionally, the course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v1.0 Course Released on 10/29/2024

Author

Nick Cohen

GxP Quality Assurance Expert

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