| Time (UTC+7) | Topic | MC/Chair | Speaker* | |
| Name | Title | |||
| Start at 08.30 | Participants Registration | Video Presentation & Safety Induction | ||
| 09.30-09.35 | Opening | MC UI | ||
| 09.35-09.40 | Opening remarks 1 | MC UI | H.E. KIYA Masahiko | "Ambassador Extraordinary and Plenipotentiary Mission of Japan to ASEAN" |
| 09.40-09.45 | Opening remarks 2 | MC UI | Ms. ENDO Ayumi | Office Director of Asia Training Center and International Cooperation (OAIC), PMDA |
| 09.45-09.50 | Opening remarks 3 | MC UI | Prof. Dr. Hamdi Muluk, M.Si. | Vice Rector of UI for Research and Innovation |
| 09.50-10.10 | Opening remarks 4 /Key Note Lecture | MC UI | Prof. Dante Saksono Harbuwono | Vice Minister of Health |
| 10.10-10.25 | Photo Session | MC UI | "Photo Session Photo Session 1: For all opening remarks speakers and all other speakers, to be held on the stage. Photo Session 2: For all VVIP guests with all speakers, also to be held on the stage. Photo Session 3: For all VIPs, VVIPs, AMS, all participants, and all IA at their respective chairs." |
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| 10.25-10.45 | Coffee Break/ Press Conference | MC UI Moderator: Public relations team |  Prof. Dante SaksonoHarbuwono" | Vice Minister of Health |
| Dr. L. Rizka Andalusia, Apt., M.Pharm., MARS (co-speaker) | Director General for Pharmaceutical and Medical Devices, Ministry of Health" |
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| H.E. KIYA Masahiko | Ambassador Extraordinary and Plenipotentiary Mission of Japan to ASEAN" |
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| Dr. KITAHARA Jun | Head of PMDA Asia Office |
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| Prof. Dr. Arry Yanuar, M.Si., Apt. | The Dean of Faculty of Pharmacy UI |
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| Prof. Dr. Hamdi Muluk, M.Si. | Vice Rector of UI for Research and Innovation" |
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| 10.45-11.45 | Session 1 (Lecture 40min + Q&A 20min) Overview of global trend on MD Regulation 1. Current Status of IMDRF 2. Regulatory Reliance in the field of MD 3. Q&A (20min) | MC UI Moderator: Ms. ENDO Ayumi, Office Director of Asia Training Center and International Cooperation (OAIC), PMDA, Japan | Ms. YAMADA Hiromi Dr. ISHIBASHI Kenichi | Principal Reviewer, Office of In Vitro Diagnostics, Pharmaceuticals and Medical Devices Agency (PMDA) Senior Scientist, Pharmaceuticals and Medical Devices Agency (PMDA) |
| 11.45-13.15 | Lunch (Break) / Visit Medical Devices Exhibition in Indonesia 2025 | |||
| 13.15-14.15 | Session 2 (Lecture 40 min + Q&A 20min) Recent topics ～Current status of SaMD～ 1. Recent innovation and development of CADe/CADx medical devices in Japan 2. The Future of Clinical Practice: Leveraging HMI Data from Medical Devices 3. Q&A (20min) | MC UI Moderator: Ms. ENDO Ayumi, Office Director of Asia Training Center and International Cooperation (OAIC), PMDA, Japan | Dr. ITAI Yoshinori Ms. HAGIWARA Hiroko | Manager, IT Solution Division, Medical Business Division FUJIFILM Corporation Operating Officer, General Manager of Clinical Development & Regulatory Affairs Division, Nihon Kohden |
| 14.15-14.25 | Coffee Break | |||
| 14.25-16.15 | Session 3 (Lecture 60min + Panel Discussion 30min + Q&A 20min) Current status and Future for Medical Device Regulation in ASEAN 1. Current status of ASEAN-AMDC 2. Industry Perspectives: Strategies to Intensify Research and Development Collaboration and Promote Technology Transfer for Innovative Medical Devices 3. WHO Prequalification of Medical Devices and IVDs 4. Panel Discussion 5. Q&A (20min) | MCUI Moderator: Ms. Siti Sari Septiani, Minister of Health of the Republic of Indonesia | Ms. Eva Zahrah, S.Farm., Apt. Ms. Febie Yuriza Poetri, M.Sc. Ms. Irena Prat All Symposium Speakers | Vice Chair of ASEAN Medical Device Committee (AMDC), Ministry of Health, Republic of Indonesia. Director of Marketing & Finance, PT Graha Teknomedika Indonesia (Indonesia) Team Lead, In Vitro Diagnostics Assessment, World Health Organization (online) |
| 16.15-16.25 | Closing Remarks | MC UI | Prof. Dr. apt., Arry Yanuar, M.Si. | The Dean of Faculty of Pharmacy UI |
* Language: English
| Time (UTC+7) | Topic | MC/Chair | Speaker* | |
| Name | Title | |||
| Start at 09.30 | ||||
| 09.30-09.35 | Opening | Mr. Hayato Ishida PMDA | Ms. Ayumi Endo | Office Director, Office of Asia Training Center and International Cooperation(OAIC), PMDA |
| 09.35-12.30 | Session 1(10min/each AMS x 10: Presentation 7min + Q&A 3min) Round Table Discussion 1.Current status and challenges for Medical Device Regulations in each AEAN Member States 2.Future Outlook | Mr. Hayato Ishida PMDA | AMS representative in alphabetical order 1. Brunei Darussalam 2. Cambodia 3. Indonesia 4. Lao PDR 5. Malaysia 6. Myanmar 7. Philippines 8. Singapore 9. Thailand 10. Viet Nam | |
| 12.30-13.30 | Lunch (Break) | |||
| 13.30-14.30 | Session 2 (Lecture 40min+Q&A 20min) 1. Standard workshop 2. Q&A (20min) ※ | Mr. Hayato Ishida PMDA | Mr. Yuki Morishita | Division of Standards for Medical devices Office of Vigilance and Standards for Medical Devices, PMDA |
| 14.30-15.05 | Session 3 (Lecture + Q&A 35min) | Mr. Hayato Ishida PMDA | Mr. Jeffri Ardiyanto | Director of Pharmaceuticals and Medical Devices Resilience, MoH of RI |
| 15.05-15.20 | Break | |||
| 15.20-16.50 | Session 4 (Lecture 70min+Q&A 20min) Medical Device Single Audit Program（MDSAP） 1. Current Status of MDSAP 2. Industry Perspective for MDSAP 3. Q&A (20min) ※ | Mr. Hayato Ishida PMDA | Dr. Kenichi Ishibashi Dr. Naoki Morooka | Senior Scientist, PMDA Senior General Manager, Medical Regulatory Policy Division, Shimazu Corporation |
| 16.50-17.00 | Seminar Evaluation (Day1) | All Seminar Participants | ||
| 17:00- | Photo Session End of Seminar (Day1) | |||
* Language: English
| Time (UTC+7) | Topic | MC/Chair | Speaker* | |
| Name | Title | |||
| Start at 09.30 | ||||
| 09.30-11.30 | Session 5 (Guidance 10min+Lecture 10min +Group Discussion 10min+ Presentation 10min)x3, etc.) Review of high-risk MD Case study | Ms. Natsuko Ito / Mr. Yuki Morishita, PMDA | Ms. Natsuko Ito / Mr. Yoshitomo Watanabe (pre-record) | Reviewer, Office of Medical Devices I, PMDA |
| 11.30-11.45 | Break | |||
| 11.45-12.30 | Session 6( Lecture 30min+Q&A 15min) 1. Review of SaMD 2. Q&A (15min) ※ | Mr. Kaito Shimizu, PMDA | Mr. Yuki Furusawa (online) | Reviewer, Office of Software as a Medical Device, PMDA |
| 12.30-13.30 | Lunch (Break) | |||
| 13.30-14.15 | Session 7 (Lecture 30min+Q&A 15min) 1. Review of IVDs 2. Q&A (15min) ※ | Mr. Hayato Ishida /Mr. Kaito Shimizu, PMDA | Ms. Hiromi Yamada | Principal Reviewer, Office of In Vitro Diagnostics, PMDA |
| 14.15-15.00 | Session 8 Seminar Wrap up and General Discussion | Mr. Hayato Ishida, PMDA | ||
| 15.00-15.15 | Break/ Seminar Evaluation (Day2) | |||
| 15.15-15.40 | Photo Session and Closing Ceremony | Mr. Hayato Ishida /Mr. Kaito Shimizu, PMDA | AMS representative Ms. Ayumi Endo | Office Director, Office of Asia Training Center and International Cooperation(OAIC), PMDA |
* Language: English