ICH E6(R3) Training Program Under the auspices of Mesned Pharma Consult Center In Cooperation with ICH Experts from Egyptian Drug Authority

Learning Objectives:

To equip clinical research professionals with the knowledge and skills necessary to conduct clinical trials in compliance with ICH E6(R3) guidelines, ensuring data integrity, participant safety, and ethical conduct.

Targeted Trainees:

• Pharmaceutical industrial
• Investigators
• Study Coordinators
• Data Managers
• Ethics Committee Members
• Sponsor Representatives / CROs
• Monitors (CRAs)

Trainer’s;

• Dr. Rania Ibrahim Shousha – Manager of Protocols and Clinical Studies Follow-up Administration
• Dr. Dalia Kamal – Manager of the Pharmaceutical Protocols Unit at Protocols and Clinical Studies Follow-up Administration

Program Agenda 

Day 1: Introduction to ICH E6(R3) and GCP Principles
Objectives:

Understand the historical context and purpose of ICH GCP.
Identify the core principles of GCP and their importance.
Define the roles and responsibilities of key stakeholders in clinical trials.

Day 2: Sponsor Responsibilities, Monitoring, and Quality Management
Adverse Event Reporting & Safety Assessment in Clinical Trials: Regulatory Requirements and Best Practices
Objectives:

• Describe the responsibilities of sponsors in ensuring the quality and integrity of clinical trials.
• Understand the importance of monitoring and quality management in clinical research.
• Explain the concept of risk-based monitoring and its implementation.
• Apply principles of data integrity and data quality in clinical trials.
• Describe the requirements for computerized systems used in clinical research.
• Understand the process of adverse event reporting and management.

Day 3: IRB/IEC, Investigator Responsibilities and Essential Documents
Data Management, and Computerized Systems
Objectives:

• Explain the role and function of IRB/IEC in protecting the rights and welfare of trial participants.
• Describe the responsibilities of investigators in conducting ethical and compliant clinical trials.
• Identify essential documents required for clinical trials and their significance.
• Apply principles of data integrity and data quality in clinical trials.
• Describe the requirements for computerized systems used in clinical research.
• Understand the process of adverse event reporting and management.