Time

Topics

Speakers

09:30 - 10:10(40‘)

▪Registration (등록 및 안내)

10:10 - 10:20(10‘)

▪Opening Remarks (개회사)

Sohn Yeowon

(Director General, NIFDS, MFDS)

10:20 – 10:30(10‘)

▪Group Photo (단체 사진 촬영)

-

Session Ⅰ. Medical Device Industry and Regulatory Science in the Age of the Fourth Industry Revolution - 4차 산업혁명 시대에 따른 의료기기 산업과 규제과학 -

Chair : Hye-Kyung(Rachel) Chung(Director, Intuitive Surgical Korea)

10:30 - 11:00(30‘)

▪Medical Device in the Age of the Fourth Industry Revolution

- 4차 산업혁명 시대의 의료기기 -

Piet Hinoul

(Vice President, Ethicon, Johnson & Johnson)

11:00 - 11:30(30‘)

▪Current Medical Device Regulations and Changes for the Fourth Industry Revolution

- 4차 산업혁명에 따른 선진국 의료기기 규제 현황 및 변화 -

Brian Kersten

(Vice President,

Abbot Vascular)

11:30 - 12:00(30‘)

▪Success Story and Strategy of Korean Medical Device Manufacturing Company in the age of the Fourth Industry Revolution- 4차 산업혁명시대의 제조업체 해외 성공사례 및 전략 -

Seung-Yong Hong

(Vice President, NEOFECT)

12:00 - 12:30(30‘)

▪Panel Discussion (패널 토론)

All Participants

12:30 - 13:30(60‘)

Lunch (중식)

All Participants

Session Ⅱ. Evolution of Medical Devices in the Age of the Fourth Industry Revolution - 4차 산업혁명 시대에 따른 의료기기 진화 -

(Chair : Dr. Kyu-Sung Lee (Prof., Sungkyunkwan University School of Medicine)

13:30 - 13:55(25‘)

▪Implementation of Big Data and Artificial Intelligence in Medical Device- 빅데이터 및 인공지능 기술 의료기기의 의학적 적용 및 역할 -

Hyun-Jun Kim

(Vice President,

VUNO)

13:55 - 14:20(25‘)

▪Medical Robots and its application in the Medical Fields- 의료용 로봇의 의학적 적용 -

Maggie Nixon

(Sr. Director,

Intuitive Surgical, Inc.)

14:20 - 14:45(25‘)

▪Trends and Future of Precision Medical Technology Using In Vitro Diagnostic Medical Devices- 체외진단의료기기를 활용한 정밀의료 기술동향과 미래 -

Jintao Chen

(Director,

Roche Molecular Systems Inc.)

14:45 - 15:10(25‘)

▪Opportunities and Challenges with the Development of Personalized Medical Device- 개인맞춤형 의료기기 개발에 따른 기회와 도전 -

Aaron Santner

(Regulatory Scientist, Cook Medical)

15:10 - 15:40(30‘)

▪Panel Discussion (패널 토론)

All Participants

15:40 - 16:00(20‘)

Tea Time (휴식)

-

Session Ⅲ. IMDRF & Global Regulatory Harmonization(Government to Business)- 국제의료기기규제당국자포럼 및 글로벌 규제 조화 -

Chair : Dr. Jeong-Rim Lee (Director of Cardiovascular Devices Division, MFDS)

16:00 - 16:20(20‘)

▪Medical Device Single Audit Program(MDSAP)- 의료기기 단일 품질 심사 -

Fabio Pereira Quintino

(Manager,

ANVISA, Brazil)

16:20 - 16:40(20‘)

▪Regulated Product Submission(RPS)- 국제 공통허가심사서류 -

Nancy Shadeed

(Special Advisor,

Health Canada, Canada)

16:40 - 17:00(20‘)

▪Russian Medical Device Regulation and Authorization Procedure of the Eurasian Economic Union(EAEU)- 러시아 의료기기 규제 및 유라시아 경제 연합의 허가 절차 -

Amiran Preobrazhensky

(Deputy Head,

ROSZDRAVNADZOR, Russia)

17:00 - 17:20(20‘)

▪U.S. FDA’s Unique Device Identification(UDI) Rule- 미국 FDA의 의료기기 고유식별코드 현황 -

William M. Sutton

(Assistant Country Director,

FDA China Office, USA)

17:20 - 17:50(30‘)

▪Panel Discussion (패널 토론)

All Participants

17:50 - 18:00(10‘)

▪Closing Remarks (폐회사)

Dr. Hee-Kyo Jeong (Director General, Medical Evaluation Department, MFDS)