Therapeutic risk management is an important component of strategic planning. This conceptual approach has been used in various fields such as the high-tech industry sector, the financial sector, and the health care sector. The importance of a therapeutic risk management conceptual framework has been adopted in the healthcare and pharmaceutical sectors. Therapeutic risk management serves as a part of an effective quality assurance system.
As we know, risks can arise from various sources. The definition of risk is a combination of the likelihood of a harm occurring and the severity of that harm. Different stakeholder attitudes and perceptions of risk can have an impact on risk management implementation. In the context of the pharmaceutical industry, there are several stakeholders such as patients, doctors, pharmacists and the government. Apart from that, ensuring patient safety by managing risks in the quality system and production processes is a major focus in the pharmaceutical industry.
Drug development programs are always associated with risk. It is important to understand that a consistent method is needed to maintain drug quality and ensure patient safety throughout the entire development process. An effective risk management approach can serve as a tool to help keep the quality of medicinal products for patients. A good therapeutic risk management can facilitate and increase the effectiveness of risk-related decision making.
Topic of The Meeting
Topic: “The Importance of Big Data in Improving the Quality of Healthcare” volume III
Subtopic: THERAPEUTIC RISK MANAGEMENT
Meeting Objectives
To increase awareness of the importance of therapeutic risk management in improving the quality of health services, both for routine healthcare services, policy formulation, and research.
To define the issues regarding the quality of health services and drug evaluation in Indonesia.
To provide an understanding of medical device risk management.
Discuss the work plan for risk control in the Indonesian health sector..
Therapeutic Risk Management using the Clinical Practices Research Datalink
Eleanor L. Axson, PhD
Clinical Practices Research Datalink, Medicines & Healthcare products Regulation Agency, UK
Materi
Quality of Care
Prof. dr. Adi Utarini, M.Sc., M.P.H., Ph.D.
Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
Materi
Drug Evaluation
Dr. Lucia Rizka Andalusia, Apt,. M.Pharm, MARS
Director of Drug Registration, National Agency for Drug and Food Control (Badan POM RI)
Materi
Risk Minimization Action Plans
Dra. Lucky S. Slamet, Apt, M.Sc.
Independent Regulatory Expert
Materi
Failure Mode And Effects Analysis (FMEA)
Dr. dr. Hanevi Djasri, MARS, FISQua
Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
Materi
