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第十一屆台日醫藥交流會議 11th Joint Conference of Taiwan and Japan on Medical Products Regulation

刊登日期:2023-08-10  |  點閱次數 : 4298 次 
主辦單位: 公益財團法人日本台灣交流協會
臺灣日本關係協會
協辦單位: 厚生勞動省
獨立行政法人醫藥品醫療機器綜合機構
衛生福利部食品藥物管理署
財團法人醫藥品查驗中心
活動地點: 國家生技研究園區C201會議室(臺北市南港區研究院路一段130巷99號C棟2樓)/線上視訊
活動日期: 112年10月5日(四)08:30~17:25

衛生福利部食品藥物管理署為推動台灣與日本醫藥合作,委託財團法人醫藥品查驗中心辦理「第十一屆台日醫藥交流會議」,訂於112年10 月5日(星期四),以實體與線上視訊同步方式舉辦,議程如下,本屆會議由台方主辦。

會中將提供中日文口譯,參與實體會議者需攜帶有照片的證件進行口譯設備借取。本會議不收取任何費用,本場次實體限額250 名、線上限額700名,為免向隅,敬請及早報名。線上會議連結網址將於會前另以Email通知。

會議議程

【Joint Session】
08:30-09:00 (TW)
09:30-10:00 (JP)
Registration
Opening Remarks
09:00-09:30 (TW)
10:00-10:30 (JP)

1. Mr. Ching-Hung Lin, Deputy Secretary General, Taiwan-Japan Relations

    Association

2. Mr. HATTORI Takashi, Deputy Representative, Taipei Office, Japan-Taiwan

    Exchange Association

3. Dr. Shou-Mei Wu, Director General, TFDA

4. Mr. YADA Shinji, Senior Executive Director, PMDA

5. Mr. Tung-Mao Su, President, TPMA

6. Dr. NAKAGAWA Sachiko, Managing Director, JPMA

7. TMBIA

8. JFMDA (On-line)

 

Photo session: Group Photo

Keynote Speeches
09:30-09:50 (TW)
10:30-10:50 (JP)
Regulatory Updates in Taiwan Dr. Shou-Mei Wu, Director General, TFDA
09:50-10:10 (TW)
10:50-11:10 (JP)
Regulatory Updates in Japan Dr. TANAKA Daisuke, Office Director, Office of International Programs, PMDA
10:10-10:30 (TW)
11:10-11:30 (JP)
Q&A
【Pharmaceuticals】

RWD/RWE for Acceleration Clinical Development

Moderator: Mr. Chien-Liang Lin, Director of Division of Medicinal Products, TFDA

10:30-10:45 (TW)
11:30-11:45 (JP)
Establishment of RWD/RWE from Biobank for Industrial Application in Taiwan: a Pilot Project 

Dr. Shiu-Feng Huang, Investigator

and Attending Physician, National

Health Research Institutes

10:45-11:00 (TW)
11:45-12:00 (JP)
Utilization RWD/RWE (for premarket review) Mr. KOGA Daisuke, Director, Office of International Regulatory Affairs, MHLW
11:00-11:15 (TW)
12:00-12:15 (JP)
Q&A

New Drug Review Cooperation between Japan and Taiwan

Moderator: Mr. KUROIWA Kenji, Deputy Director, Office of International Regulatory Affairs, MHLW

11:15-11:30 (TW)
12:15-12:30 (JP)

Current Progress on New Drug

Review Cooperation between

Taiwan and Japan

Dr. Wen-Yi Hung, Senior Reviewer,

Division of Medicinal Products,

TFDA

11:30-11:45 (TW)
12:30-12:45 (JP)

New Drug Review Cooperation –

Next Step

Mr. YASUDA Naoyuki,

Associate Executive Director, PMDA
11:45-12:00 (TW)
12:45-13:00 (JP)

Q&A

12:00-13:00 (TW)
13:00-14:00 (JP)
Lunch

Regenerative Medicinal Products Regulation

Moderator: Ms. Ming-Mei Wu, Deputy Director, Division of Medicinal Products

13:00-13:20 (TW)
14:00-14:20 (JP)

Regulation of Regeneration

Medicinal Products in Taiwan

Ms. Mei-Chen Huang,

Senior Technical Specialist, Division

 of Medicinal Products, TFDA 

13:20-13:40 (TW)
14:20-14:40 (JP)

Regulation for Regenerative

Medicinal Products

Dr. MARUYAMA Yoshiaki, Office of

Cellular and Tissue-based Products,

PMDA

13:40-14:00 (TW)
14:40-15:00 (JP)
Q&A

Health Insurance for Sustainable Universal Health Coverage

Moderator: Industry

14:00-14:20 (TW)
15:00-15:20 (JP)

Strategies on New Drug

Reimbursement of Taiwan’s NHI

System

Dr. Yu-Wen Huang, Director of

Medical Review and

Pharmaceutical Benefits Division, NHIA

14:20-14:40 (TW)
15:20-15:40 (JP)

Drug Pricing System in Japan

 Mr. SAWADAISHI Katsuya, Deputy 

 Director, Deputy Director,

 Economic Affairs division, Health

 Policy Bureau, MHLW

14:40-15:00 (TW)
15:40-16:00 (JP)
Q&A
15:00-15:15 (TW)
16:00-16:15 (JP)
Break
【Medical Devices】

Cybersecurity for Medical Devices

Moderator: Ms. Pei-Weng Tu, Director, Division of Medical Devices and Cosmetics, TFDA

15:15-15:35 (TW)
16:15-16:35 (JP)
Cybersecurity Evaluation Requirements for Medical Device Product Registration and Regulatory Update Product Registration and Regulatory Update Mr. Shiu-Huei Yeh, Section Chief, Division of Medical Devices and Cosmetics, TFDA
15:35-15:55 (TW)
16:35-16:55 (JP)

Cybersecurity Requirements for

Medical Device Product Registration

Mr. IMAGAWA Kuniki, Deputy Division Director, Office of Standards and Compliance for Medical Devices/ Office of Software as a Medical Device, PMDA
15:55-16:15 (TW)
16:55-17:15 (JP)
Q&A

Sharing of Latest Medical Device Issues

Moderator: Mr. MIYASAKA Tomoyuki, Deputy Director, Medical Device Evaluation Division, MHLW

16:15-16:35 (TW)
17:15-17:35 (JP)
UDI Regulations in Taiwan  Mr. Hsiu-Te Lin, Section Chief, Division of Medical Devices and Cosmetics, TFDA
16:35-16:55 (TW)
17:35-17:55 (JP)
Remanufactured-Single Use Device in Japan Mr. MIYAKE Manabu, Deputy Division Director, Office of Manufacturing Quality and Vigilance for Medical Devices, PMDA
16:55-17:15 (TW)
17:55-18:15 (JP)
Q&A
【Joint Session】
Closing Remarks
17:15-17:25 (TW)
18:15-18:25 (JP)
1. Dr. Shou-Mei Wu, Director General, TFDA
2. Mr. YASUDA Naoyuki, Associate Executive Director, PMDA

 

報名資訊
報名方式 本課程僅由線上報名,恕不接受電話或其他方式報名。
報名人數 本活動採實體與線上視訊同步方式舉辦實體限額250 名線上限額700名
承辦單位亦得視狀況隨時截止報名,並保留報名資格之最後審核權利。
報名時間 自公告日起至112年9月28日(四)17:00
報名費用 不需繳納費用。
與會須知 1. 會議進行期間未獲許可,請勿錄音錄影。
2. 線上會議連結網址將於會前另以Email通知,報名時請務必留下正確Email。
聯絡窗口 姓名:張專員或 林企劃經理
電話:02-8170-6000 分機 631 或 625
信箱:events@cde.org.tw