PPT-Report to LSIF: Regulatory Harmonization

Steering Committee RHSC Update Michelle Limoli Nobumasa Nakashima CoChairs RHSC 24 February 2021 Regulatory Harmonization Steering Committee Mission facilitate regulatory cooperation among medical product regulatory authorities build human capacity in regulatory science among medical product regulatory staff and promote political will for convergence among regulatory policymakers in APEC. in ISO/TC 211 standards. . by Serena Coetzee. Chair, ISO/TC 211 . Programme. Maintenance Group. at the Tutorial held on. 5 December 2010 in Canberra, Australia. The Challenge. 40+ published ISO/TC 211 standards. What to Anticipate. July 2017. . Oliver Ireland & Anna Pinedo, Morrison & Foerster LLP . Paul . Kupiec. , American Enterprise Institute . Dodd-Frank. 2. Signed into law on July 21, 2010. Circa 370,000 words. Sofia . Delipalla. Professor . in . Economics. University of Macedonia, Thessaloniki, Greece. and . WHO . Adviser. . sd@uom.edu.gr. Win-Win for Public Health & Domestic Resources Mobilization Conference. Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. and Options for Regulators. Institute of Medicine Workshop . International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development. Washington DC, February 13-14, 2013. Capacity Building and Harmonization Support. Regulatory . Systems Strengthening [RSS]. Regulation of Medicines and Other Health Technologies [RHT]. Department of Essential Medicines and Health Products [EMP]. . Tominaga. Ph. D.. Food and Drug Evaluation Center, Osaka City Univ. Hospital. International Regulatory Harmonization Amid Globalization of. Biomedical Research & Medical Product Development: An . (i.e. no one has seen or approved this). Draft 07/01/13. Coordination. This is the point at which we need to truly start integrating the work products of the subgroups. .. We need to look at the safety issues and assess whether they are addressed. Institute of Medicine Workshop . International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development. Washington DC, February 13-14, 2013. Mike Ward. Health Canada. Capacity Building and Harmonization Support. Regulatory . Systems Strengthening [RSS]. Regulation of Medicines and Other Health Technologies [RHT]. Department of Essential Medicines and Health Products [EMP]. Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. Deputy Secretary General &. Dean of the World-Wide Academy. Harmonization. is Key. Shipping is by its very nature mobile and global. . Shipowners may be willing to equip their new-buildings with state-of-the-art technology to maximize their competitive advantage and operational safety, but they are reluctant to spend money on multiple sets of equipment just because different regions of the world have developed their own digital solutions which are incompatible with each other. . FE Workshop, . 80. th. . GRPE, Geneva . 14. January 2020. 1st WS of HD FE Harmonization. First . Workshop organized . during in GRPE of Jan. 2019 . kicked-off HD FE . Harmonization with participation . . of. Corporate . Governance. :. What. . has. . it. . Achieved. ?. . 2. von . EU Harmonization of Corporate Governance: What has it Achieved?. I. . Introduction. II. A Survey . of. Major Initiatives.