Term of References

Seminar DaringThe Importance of Big Data  in Improving the Quality of Healthcare” vol. III


Online Zoom Meeting and Livestreaming Youtube

Saturday, 27 February 2021

14.55 – 17.15 WIB (GMT+7)


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


Meeting Objectives

  1. 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.
  2. To define the issues regarding the quality of health services and drug evaluation in Indonesia.
  3. To provide an understanding of medical device risk management.
  4. Discuss the work plan for risk control in the Indonesian health sector..


  1. Staffs from the Ministry of Health (from several Directorates)
  2. Staffs from BPJS Kesehatan (Healthcare and Social Security Agency)
  3. Staffs from Badan POM (Indonesian FDA)
  4. Organizers and members of PERSI (Indonesian Hospital Association)
  5. Members of IDI (Indonesian Medical Doctor Association)
  6. Members of IAI (Indonesian Pharmacist Association)
  7. Academia
  8. Organizers and Members of IPMG (International Pharmaceutical Manufacturers Group)
  9. Organizers and Members of GP Farmasi (National Association of Local Pharmaceutical Manufacturer Companies)
  10. Other participants

Schedule of The Meeting

Time Topic Resource Person
14.55 – 15.00


Opening The Head of Department of Pharmacology, Faculty of Medicine, Nursing, and Public Health, Universitas Gadjah Mada
15.00 – 15.30


Therapeutic Risk Management using the Clinical Practices Research Datalink

Eleanor L. Axson, PhD

Clinical Practices Research Datalink, Medicines & Healthcare products Regulation Agency, UK

15.30 – 15.45


Discussion (session 1) Moderator:

dr. Alfi Yasmina, M.Sc., Ph.D.

Faculty of Medicine, Universitas Lambung Mangkurat

15.45 – 16.00


Quality of Care

Prof. dr. Adi Utarini, M.Sc., M.P.H., Ph.D.

Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada

16.00 – 16.15


Drug Evaluation

Dr. Lucia Rizka Andalusia, Apt,. M.Pharm, MARS

Director of Drug Registration, National Agency for Drug and Food Control (Badan POM RI)

16.15 – 16.30


Risk Minimization Action Plans

Dra. Lucky S. Slamet, Apt, M.Sc.

Independent Regulatory Expert

16.30 – 16.45


Failure Mode And Effects Analysis (FMEA)

Dr. dr. Hanevi Djasri, MARS, FISQua

Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada

16.45 – 17.15


Discussion (session 2) Moderator:

Anis Fuad, S.Ked, DEA

Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada

Video Recording