台灣-泰國-美國 三校聯合醫療器材法規科學國際研討會

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.
  • 日    期:2024-03-12 ~ 2024-03-15
  • 地    點: Rajaratana Building (Room 206), Faculty of Pharmacy, Mahidol University
  • 主辦單位:國立成功大學
  • 活動網址

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) 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
  1. Collaborate with Mahidol and USC Regulatory Science Programs as well as the Mahidol Biomedical Engineering Program.
  2. Cultivate interactions among regulatory agencies, the industry, and regulatory affairs within Thailand and beyond.
  3. 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 Academic Service Supporting Unit, Faculty of Pharmacy, Mahidol University
Mobile. 087-5597393, E-mail: [email protected]
Conference Email: [email protected]
 
Cohosts
  1. National Cheng Kung university, Taiwan
  2. University of Southern California, USA
  3. Medical Device Control Division, Thai Food and Drug Administration
  4. 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
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