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الرئيسية غير مصنف ICH E6(R3) Training Program Under the auspices of Mesned Pharma Consult Center In Cooperation with ICH Experts from Egyptian Drug Authority
Qualified Person form Pharmacovigilance (QPPV) SAR  3,277
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Quality Management Systems - Risk Management – Risk Assessment and Control SAR  1,150
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ICH E6(R3) Training Program Under the auspices of Mesned Pharma Consult Center In Cooperation with ICH Experts from Egyptian Drug Authority

SAR  2,165

التصنيف: غير مصنف
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الوصف
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.
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  • الموقع : السعودية - الرياض.
  • رقم الهاتف:
    (+966)920019011
  • البريد الالكتروني:
    info@mesned.com
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