Facilitating Interaction between Innovation & Regulation

Workshop: Emerging Regulatory Science - Building a platform for forecasting and identification (2017/11/3)

Date & Time: 2018/11/03 13:30-17:30
Venue: Ito International Research Center, The University of Tokyo
RISTEX２期プロジェクトの開始にあたり、メンバーの作業仮説について、日米の規制当局の研究機関 (NCTR, NIHS)、AMED等のファンディングエージェンシー、RISTEX「科学技術イノベーション政策のための科学 研究開発プログラム」のマネジメントチームのメンバー、規制科学の研究者を交えて検証すること、萌芽的技術の出現に対する早期対応のインフラについて議論することを目的として開催しました。

Time/ Session	Contents	Name	Affiliation
Opening Remark	The role of “Social Science on Regulatory Science (SSRS)"	Shingo Kano	UT
Session 1	Emerging regulatory science and Global Summit on Regulatory Science (GSRS)
13:30-13:40	1. Introduction: SSRS Report: GSRS -Historical Review	Shingo Kano	UT
13:40-13:50	2. GSRS: NCTR’s Perspective	Tong Weida	FDA/NCTR
13:50-14:00	3. GSRS: Japan’s Perspective	Ryusuke Nakaoka	NIHS
14:00-14:25	4. Discussion: Identifying what’s the next Emerging Regulatory Science
Session 2	New Guideline/ISO Formations and related Activities in Japan
14:30-14:40	1. Introduction: SSRS Report: Japanese Case - JISEDAI /SAKIGAKE & ISOs	Shingo Kano	UT
14:40-14:50	2. Japan’s Commitment: Case of ICHS7B/E14	Sekino Yuko	UT
14:50-15:00	3. Japan’s Commitment: Case of ISO16578	Hiroki Nakae	JMAC
15:00-15:10	4. How guidelines and ISOs linked? Case of JISEDAI	Shingo Kano	UT
15:10-15:25	5. Discussion: Designing the communication between Innovators and Regulators
Session 3	New Challenges in the RISTEX project
15:40-15:50	1. Regulatory Horizon Scanning: Concept Proposal	Shingo Kano	UT
15:50-16:00	2. Guideline of Guidelines : Points to consider in Japan	Chiaki Sato	Aoyama Gakuin
16:00-16:10	3. Designing a New type Organization	Yuko Hayashi Yuko Sekino	Yamaguchi Univ UT
16:10-16:25	4. Discussion: Missing functions in the Regulatory Value Chain
Session 4	Emerging Regulatory Science and its Research Engine -Resource Perspective
16:30-16:40	1. Introduction: SSRS Report: Regulatory Research Engine (RRE) -Functional Definition	Shingo Kano	UT
16:40-16:50	2. Resource for RRE in Regulatory Agency -NCTR’s Case	Slikker William	FDA/NCTR
16:50-17:00	3. Resource for RRE in Universities	Ichiro Sakuma	UT
17:00-17:15	4. Discussion: Building a network for RRE
17:15-17:30	Free Discussion