台灣-泰國-美國 三校聯合醫療器材法規科學國際研討會
This international conference will unite three esteemed universities from across the globe and four renowned programs specializing in biomedical engineering and regulatory science. Together, they converge at Mahidol University, solidifying its position as the forefront of digital health product innovation in Thailand.
活動介紹
台灣-泰國-美國 三校聯合醫療器材法規科學國際研討會
(成大-Mahidol-南加大) 在泰國曼谷舉行 ,歡迎各界踴躍參加
Rationale and Background Thailand 4.0, launched in 2016, is a comprehensive 20-year master plan designed to facilitate Thailand's transition into the Industry 4.0 era. This endeavor encompasses various sectors, with a particular focus on the medical sector. It is driven by the concerted efforts of two influential government initiatives. “Innovation Thailand” is spearheaded by National Innovation Agency (NIA). Its primary objective is to position Thailand among the top 30 nations on the Global Innovation Index by 2030. The "Thai Innovation List" was initiated by the National Science and Technology Development Agency (NSTDA).” This program highlights and supports Thai entrepreneurs who have harnessed research and innovation from higher education institutions and research institutes. Its overarching aim is to reduce healthcare costs by promoting the domestic production of medical products within Thailand.
Nevertheless, the manufacturing of digital health products and technologies (e.g. smart devices, medical devices, medical artificial intelligence, etc) demands rigorous scrutiny from regulatory authorities, including the Thai FDA and other regulatory agencies. This stringent oversight is essential to ensure the safety and efficacy of these medical products. In this regard, Mahidol University's Regulatory Science Program holds a unique position as the sole program of its kind not just in Thailand but across the entire ASEAN region. It assumes a distinctive and vital role in this field. This international conference will unite three esteemed universities from across the globe and four renowned programs specializing in biomedical engineering and regulatory science. Together, they converge at Mahidol University, solidifying its position as the forefront of digital health product innovation in Thailand. |
Objectives
- Collaborate with Mahidol and USC Regulatory Science Programs as well as the Mahidol Biomedical Engineering Program.
- Cultivate interactions among regulatory agencies, the industry, and regulatory affairs within Thailand and beyond.
- Promote international cooperation and collaboration in the development of medical devices and the convergence of regulatory standards.
Host Organizations
Master of Science Program in Regulatory Sciences for Pharmaceutical and Health Products (International Program), Faculty of Pharmacy, Mahidol University
- Prof. Dr. Leena Suntornsuk, Email: [email protected]
- Assoc. Prof. Dr. Chutima Phechkrajang, Email: [email protected]
Mobile. 087-5597393, E-mail: [email protected]
Conference Email: [email protected]
Cohosts
- National Cheng Kung university, Taiwan
- University of Southern California, USA
- Medical Device Control Division, Thai Food and Drug Administration
- Faculty of Engineering, Mahidol University, Thailand
Participants
International and local pharmacists, regulators and scientists in the area of digital health products from both public and private sectors, faculty members, students and those who are interested.
Conference’s Date, Time, and Venue:
March 12-15, 2024 at Rajaratana Building (Room 206), Faculty of Pharmacy, Mahidol University
活動議程
Date/time | Topic | Speaker |
---|---|---|
12 March 2024 | ||
08.40-08.45 | Chairperson's remark | Prof. Leena Suntornsuk Faculty of Pharmacy, Mahidol University |
08.45-09.00 | Opening ceremony Welcome remark |
Assoc. Prof. Eunjoo Huisung Pacifici, Chair, Department of Regulatory and Quality Sciences, USC, USA Prof. Fong-Chin Su, NCKU, Taiwan Assoc. Prof. Surakit Nathisuwan, Dean, Faculty of Pharmacy, Mahidol University |
09.00-09.30 | Keynote lecture I : FDA regulates digital health devices | Assist. Prof. Chiaoyun Benson Kuo, USC, USA |
09.30-10.00 | Keynote lecture II : Digital health product in Thailand | Mr. Pongpat Techavijit, Medical Device Control Division, FDA, Thailand |
10.00-10.30 | Keynote lecture III : Medical device safety and performance | Prof. Kuo-Sheng Cheng, NCKU, Taiwan |
10.30-10.45 | Break | |
10.45-11.15 | Plenary lecture I : Strategic navigation of FDA registration for digital health innovation: An industry perspective | Mr. Wirun Wetsiri, Pharm Connection (Thailand) Co., Ltd. |
11.15-11.45 | Plenary lecture II : Medical Device Regulations in Taiwan and its Actions Promoting AI/ML-based Medical Device | Dr. Chia-Hung Chien, Deputy Director Taiwan FDA, Taiwan Mr. Shang-Ching Lin, Associate Technical Specialist Taiwan FDA, Taiwan |
11.45-12.15 | Plenary lecture III : FDA clinical validation requirements for AI/ML-enabled medical devices | Mr. Yu Zhao, Bridging Consulting, USA |
12.15-13.30 | Lunch break | |
13.30-14.00 | Plenary lecture IV : Labeling requirements for digital health devices | Assoc. Prof. Eunjoo Huisung Pacifici, USC, USA |
14.00-14.30 | Invited lecture I : Software as medical device &AI | How to implement and regulate in Thailand | Mr. Nakorn Tangwancharoenchai, Medical Device Control Division, FDA, Thailand |
14.30-15.00 | Invited lecture II : The key elements of QMS and/or ISO 13485 for digital health devices | Dr. Lequina Myles, USC, USA |
15.00-15.15 | Break | |
15.15-15.45 | Invited lecture III : Digital technology transforms the designs and implementations of clinical trials | Prof. Frances Richmond, USC, USA |
15.45-16.15 | Invited lecture IV : Regulation of 3D printing medical device | Dr. Chen-Hsun Weng, NCKU, Taiwan |
16.15-16.45 | Invited lecture V : Exploring the FDA regulatory framework for AI/ML-enabled medical devices | Dr. Mary Wilhelm, USC, USA |
13 March 2024 | ||
08.30-09.00 | Invited lecture VI : Biosensors, a revolution in healthcare | Assoc. Prof. Benchaporn Lertanantawong, Faculty of Engineering, Mahidol university, Thailand |
09.00-9.30 | Invited lecture VII : Design considerations for digital health devices | Prof. Gerald Loeb, Biomedical Engineering, USC, USA |
9.30-10.00 | Invited lecture VIII : Bringing a medical device to the market: Regulatory and commercializing challenges | Dr. I-Ching Fang, CEO of Codent Technial Industry Co. Ltd, Taiwan |
10.00-10.30 | Invited lecture IX : Development of rehabilitation system and software | Assoc. Prof. Panrasee Ritthipravat, Faculty of Engineering, Mahidol university, Thailand |
10.30-10.45 | Break | |
10.45-11.15 | Invited lecture X : Cybersecurity | Dr. Samuel Wang, Consultant of MDIC and GEM Consultants International CORP, Taiwan |
11.15-11.45 | Invited lecture XI : AI applications in pharmacy | Assoc. Prof. Natapol Pornputtapon, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Thailand |
11.45-12.15 | Invited lecture: XII: Pharmacy informatics and digital health system | Assoc. Prof. Anuchai Theeraroungchaisri, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Thailand |
12.15-13.30 | Lunch break | |
13.30-14.00 | Invited lecture XIII : Drug identification information technology for healthcare providers | Asst. Prof. Brompoj Prutthiwanasan, Faculty of Pharmacy, Mahidol University, Thailand |
14.00-14.30 | Invited lecture XIV : Digital disruption in dentistry | Assoc. Prof. Pong Pongprueksa, Faculty of Dentistry, Mahidol University, Thailand |
14.30-14.45 | Break | |
14.45-16.00 | Workshop I : Digital health : Introduction | Dr. Lequina Myles, USC, USA |
16.00-17.15 | Workshop II : The Q-Submission program | Mr. Yu Zhao, Bridging Consulting, USA |
14 March 2024 | ||
09.00-10.30 | Workshop III : 510k vs. De Dovo process | Dr. Lequina Myles, USC, USA |
10.30-10.45 | Break | |
10.45-12.15 | Workshop IV : Software as a medical device | Mr. Yu Zhao, Bridging Consulting, USA |
12.15-13.30 | Lunch break | |
13.30-14.00 | Exhibition | |
14.00-15.30 | Workshop V : AI/ML-enabled medical devices | Dr. Mary Wilhelm, USC, USA |
15.30-15.45 | Break | |
15.45-17.15 | Workshop VI : Cybersecurity | Mr. Jeffery Chou, Black Squid Inc., USA |
15 March 2024 | ||
Morning | Site visit : Faculty of Engineering, Mahidol University | International participants |
Afternoon | Cultural excursion | International participants |