Webinar Proyek Konvergensi Regulasi Alat Kesehatan COVID-19 (Indonesia)

COVID-19 Medical Device Regulatory Convergence Project (Indonesia)

Webinar on Good Regulatory Practices and Medical Device Regulation

Good regulatory practices (GRPs) include formalized, mandatory principles and practices by which regulatory authorities develop technical regulations for all regulated sectors, aligned with international standards. They are, in essence, a quality control mechanism that provide a benchmark for developing and implementing highest quality, cost-effective and efficient regulatory oversight. Unsurprisingly, the medical device sector is one of the most regulated sectors globally, given the diverse range of products; challenges in accurately determining safety, efficacy, and quality; complexities in production, distribution, and surveillance; and impact on health of citizens. It is therefore critical that government agencies and authorities responsible for the oversight of the medical device industry adhere to GRPs that are grounded on sound legal frameworks and international norms and standards.

This two-part webinar, held in partnership with the Government of Indonesia and Gadjah Mada University, will focus on the World Trade Organization’s (WTO) Technical Barriers to Trade (TBT) agreement and legal obligations as it relates to GRPs and Indonesia’s national commitments, global frameworks for medical device regulations, and best practices on management of safety and efficacy of medical devices.

The webinar is part of the COVID-19 Medical Device Regulatory Convergence Project (MDRC), a U.S. government-funded public-private partnership, between the U.S. Agency for International Development (USAID) and the American National Standards Institute (ANSI), in collaboration with the Advanced Medical Technology Association (AdvaMed). The MDRC’s mission is to advance regulatory convergence with key global partners, in partnership with standards developing organizations, as well as national and regional health and regulatory authorities.

The two-part webinar will be held the mornings of 15 and 22 June 2022

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Webinar 1: Global Trends in Good Regulatory Practice

Wednesday, 15 June 2022 – 0900 to 1100 Indonesia time (GMT +7)

Time	Session
09:00 – 09:10	Opening Remarks by Dr. Lucia Rizka Andalusia, Director General of Pharmaceutical Services & Medical Devices, Ministry of Health, Indonesia Introduction by Prof. Laksono Trisnantoro, Special Advisor to Indonesia’s Minister of Health for Resilience of Pharmaceutical and Medical Device Industries
09:10-09:15	Introductory Remarks by Steven Bipes, Vice President AdvaMed and MDRC Project Lead, on the MDRC, and the utility of international standards / guidance in the medical device sector, including its immediate benefits in the midst of COVID-19, and to building long-term resilience in the national health systems for future pandemics and health crises.
09:15 – 10:05	Panel: Overview of Good Regulatory Practices and Standards Moderator: Mugant Mehanathan, MDRC Lead, Southeast Asia, Crowell & Moring International Speakers Renata Amaral, GRP Lead, MDRC Konny Sagala, Director of System for Standards and Conformity Assessment Implementation, BSN Indonesia Renee Hancher, GRP Lead, Office of the U.S. Trade Representative
10:05 – 10:55	Panel: Global Frameworks for Regulation of Medical Devices Moderator: Janet Trunzo, Senior Executive Vice President, AdvaMed and Chair, Global Medical Technology Alliance Regulatory Working Group Speakers Agnes Sitta Kijo, Technical Officer, World Health Organization Wong Woei Jiuang, Assistant Group Director, Medical Devices Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore Sodikin Sadek, Director of Production and Distribution of Medical Devices, Ministry of Health, Indonesia
10:55 – 11:00	Closing Remarks by Mugant Mehanathan, MDRC Lead, Southeast Asia, Crowell & Moring International

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Webinar 2: Good Regulatory Practices in Indonesia and Stakeholder Perspectives

Wednesday, 22 June 2022 – 0900 to 1130 Indonesia time (GMT +7)

09:00 – 09:05	Introduction by Prof. Laksono Trisnantoro, Special Advisor to Indonesia’s Minister of Health for Resilience of Pharmaceutical and Medical Device Industries
09:05 – 09:10	Mugant Mehanathan, MDRC Lead, Southeast Asia, Crowell & Moring International will provide a recap of Webinar 1, and outline the objectives of the current Webinar.
09:10 – 10:00	Panel: Convergence in Medical Device Quality Management System: National Regulatory Authority and Industry Perspectives Moderator: Sandra Ligia González, Medical Device Sector Lead, MDRC Speakers: Melissa Torres, Associate Director for International Affairs, Office of the Center Director, Center for Devices and Radiological Health, US Food and Drug Administration Fikriansyah bin Irman, Health System and Strategy Officer, Ministry of Health, Indonesia Randy Teguh, Secretary General, GAKESLAB
10:00 – 11:25	Panel: Post-Market Surveillance in Indonesia Moderator: IGM Wirabrata, Apt., Head of Center for Health Security System Policy and Health Resources, Health Development Policy Agency, Ministry of Health, Indonesia Speakers: ISO/TR 20416:2020 Medical devices — Post-market surveillance for manufacturers WHO – Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics IMDRF Working Group Representative Cut Putri Arianie, Director of Medical Device Supervision, Ministry of Health, Indonesia Erwin Hermanto, Head of Division, Product Promotion, ASPAKI
11:25 – 11:30	Closing Remarks by Mugant Mehanathan, MDRC Lead, Southeast Asia, Crowell & Moring International

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