PPT-Standards-Setting in the Context of Regulatory Harmonization

Carolyn Compton MD PhD CEO and President Critical Path Institute CPath IOM Workshop International Regulatory Harmonization Washington DC February 13 2013 The Global Challenge. 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. 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. Three Levels of Context. Contextualization – Incorporating the text into your personal setting. Historical Context – Author, Recipient, Date, Situation.. . Three Levels of Context. Contextualization – Incorporating the text into your personal setting. 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 . Details in the surrounding text give you clues to the word’s meaning. . Types of Context Clues. Definition. The word is directly and clearly defined in the sentence in which it appears. . Example: “The . the Nuts and Bolts. CAGS Annual Conference. Montreal, November 4, 2013. Presented by Gordana Krcevinac, . Director, Tri-Council CGS . H. armonization . P. roject. Agenda. Why Harmonize?. CGS Background. 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. . Steering Committee (RHSC). Update. Michelle . Limoli. Nobumasa Nakashima. Co-Chairs, 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. Preparation for a Round 5 . CRF Review . Dianne M. Reeves, RN, MSN, National Cancer Informatics Program. Neesha Desai, Essex Management. June 12, 2012. Background . CTWG Vision Statement. Dr Andy Hall. Chief Nuclear Inspector. Contents. UK Response to Fukushima. EC Stress Tests. Benefits of Goal Setting Regulation. Application of Modern Standards to Older Plant. “Intelligent Customer” Arrangements and their application to... . 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.