Approach to promoting ICH standards globally

ICH Overview

ICH Members and Observers

Composition of ICH Working Groups

ICH Guideline Development

ICH Training

Eligibility Criteria: Regulators

Eligibility Criteria: Industry

Summary

Engagement is Essential to inform EWG Work

What Drug Substances/Products are Out of Scope for M7?

The Hazard Assessment: What is it?

ICH M7 Section 6: Impurity Classes

How is a Classification Provided by Industry Evaluated?

Monitoring Options Outlined in ICH M7 (Sections 8.1, 8.2, and 8.3)

Summary

Learning Objectives

Post Approval Changes

Established Conditions (EC)

Identifying ECs and the Role of Risk

Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”

Summary of Major Differences in Recommendations Between Draft M13A and the Draft FDA ANDA BE Guidance (Aug 2021)

Additional Discussion on Selected Topics

Q&A Panel Discussion

Opening remarks

History of E8

History

Overview of the E8 guideline

General principles

Scientific approach in clinical studies

Quality

Critical quality attributes

Reviewing Critical to Quality Factors

Implementation of E8

Opening Remarks

Overview of ICH

Updates on ICH Efficacy Related Guidelines: M12, Drug Interaction Studies

E2D(R1), Post-Approval Safety Data Management: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

E6(R3) Good Clinical Practice Principles and Annex 1

M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines

E14/S7B, Clinical Evaluation of Qt/QTc Interval Prolongation and Proarrhythmic Potential QnA

Topics Recently Reaching Step 4 of the ICH Process: ICH Q3D(R2)

Questions & Answers Panel

Opening Remarks

Overview of ICH

E11A, Pediatric Clinical Trials Extrapolation

Q9(R1), Quality Risk Management

Q2/Q14, Analytical Validation

What is ICH?

What are the benefits of ICH?

What is the impact of ICH on patients worldwide?

ICH Members

How has ICH evolved?

ICH Governance Structure

What is the key to continued success of ICH?

What is the key to success in the future?

Closing Remarks

Agenda

What is ICH Q11 Q&A?

Common issues in starting material selection and justification

Custom synthesized chemicals vs commercially available chemicals

How to apply ICH M7 principles in the selection of starting material

Computational toxicology assessment

Starting material selection case study

Hypothetical Drug Substance Specification

Non-isolated Intermediates

Selection of Starting Materials

Pronunciation Intro

How to Pronounce Ich

Copyright Notice

Main messages of E17

Multiregional Clinical Trials

Advantages of multi-regional clinical trials

Challenges of Multiregional Clinical Trials

Conclusion

How can the E17 guideline help?

ICH E17 Training Modules

Outro

Terminology

Impurity Classification

Summary of MDDs

Other Impurity Qualification Methods

Proposed Limits

Permitted Daily Exposure for Class 2 Solvents

Ich Q3d

How to qualify elemental impurities?

Impurity Qualification: Common Issues

Outro

What is GCP?

Who is responsible for GCP?

History of Good Clinical Practice (GCP)

History of Good Clinical Practice

Ich E6

Core principles of GCP

GCP in Europe

Why is GCP important?

Conclusion

Outro

What is ICH?

When was ICH initially founded?

Organization Structure of ICH

ICH Process for Guideline Development

ICH Guidelines

Ich Q8

Continuous Manufacturing of Drug Substance and Drug Product

Efficacy guidelines

ICH Guidelines on Pharmacogenomics and Pharmacogenetics

Conclusion