ICH Q9, titled "Quality Risk Management," provides a framework and principles for the implementation of quality risk management in the pharmaceutical industry. The purpose of ICH Q9 is to ensure a systematic and proactive approach to managing risks that may affect product quality, patient safety, and data integrity. It recognizes that risk management should be an integral part of the pharmaceutical quality system and be applied throughout the lifecycle of a product, from development to post-marketing activities. The purpose of ICH Q9 is to ensure a systematic and proactive approach to managing risks that may affect product quality, patient safety, and data integrity. It recognizes that risk management should be an integral part of the pharmaceutical quality system and be applied throughout the lifecycle of a product, from development to post-marketing activities. Overall, ICH Q9(R1) plays a crucial role in promoting a proactive and systematic approach to risk management in the pharmaceutical industry. It aligns with regulatory expectations and industry best practices, ensuring the delivery of safe and effective pharmaceutical products to patients worldwide.

Why should Attend

The training session aims to provide participants with an understanding of the International Council for Harmonization (ICH) Q9 guideline, with a focus on the revised version, ICH Q9(R1). Participants will learn about the principles, concepts, and application of the risk management approach outlined in the guideline, and how it relates to the pharmaceutical industry. This session will discuss some potential applications and tools used in the industry for Quality Risk Management. Additionally, a few examples of how to apply these applications will be reviewed.

Areas Covered in the Session

1. Introduction to ICH (Q9) R1 Regulations

• Brief overview of ICH and its purpose
• Introduction to ICH Q9 and its significance

1. Key Concepts and Definitions

• Understanding risk and risk management
• Principles of quality risk management
• Risk assessment, control, communication, and review.

3. Risk Management Process

4. Overview of the risk management process:

• Risk identification.
• Risk evaluation.
• Risk control.
• Risk communication.
• Risk review.

5. Integration of Risk Management in the Pharmaceutical Industry

• Application of ICH Q9 in pharmaceutical manufacturing
• Risk management in drug development.
• Risk management in post-marketing activities.

6. Quality Risk Management Methods and Tools

7. Potential Applications for Quality Risk Management

Target Companies

1. Biotechnology: Companies involved in biotechnology research, development, and manufacturing can benefit from understanding and implementing risk management practices outlined in ICH Q9(R1).
2.  Medical Devices: Manufacturers of medical devices can gain valuable insights into quality risk management principles to enhance product safety and comply with regulatory requirements.
3. Contract Research Organizations (CROs): CROs engaged in clinical research, data management, and regulatory support for pharmaceutical and biotechnology companies can improve their risk management practices and ensure compliance with ICH Q9(R1) guidelines.
4. Clinical Research: Professionals involved in clinical research, including clinical trial coordinators, investigators, and study sponsors, can utilize risk management principles to identify, evaluate, and mitigate risks associated with clinical trials.
5. Pharmaceutical Supply Chain: Companies involved in the pharmaceutical supply chain, including distributors, wholesalers, and logistics providers, can benefit from understanding risk management practices to ensure the integrity and quality of pharmaceutical products throughout the supply chain.

Target Association/Societies

1. American Association of Pharmaceutical Scientists (AAPS)

2. International Society for Pharmaceutical Engineering (ISPE

3. American Society for Quality (ASQ

4. Drug Information Association (DIA

5. Regulatory Affairs Professionals Society (RAPS

6. International Society for Quality in Health Care (ISQua)

7. Local pharmaceutical and biotechnology association

Target Audience to market

1. Quality Assurance/Quality Control Professionals: ·

• Quality Assurance Managers
• Quality Control Analysts
• Compliance Officers
• Regulatory Affairs Specialists

2. Manufacturing and Operations Professionals:

• Manufacturing Managers
• Process Engineers
• Validation Specialists
• Production Supervisors

3. Research and Development Professionals:

• R&D Scientists
• Formulation Scientists
• Product Development Managers

1. Regulatory Affairs Professionals

• Regulatory Affairs Managers
• Regulatory Compliance Specialists
• Regulatory Affairs Associates

4. Pharmacovigilance and Drug Safety Professionals:

• Pharmacovigilance Managers
• Drug Safety Specialists

• Medical Affairs Professionals

1. Risk Management Professionals:

• Risk Management Specialists
• Risk Assessment Analysts
• Risk Control Officers

5. Cross-Functional Team Members:

• Project Managers
• Cross-Functional Team Members involved in risk assessment and control
• Quality and Compliance Team Member