The Global academic research organization network: Data sharing to cure diseases and enable learning health systems.

Introduction:Global data sharing is essential. This is the premise of the Academic Research Organization (ARO) Council, which was initiated in Japan in 2013 and has since been expanding throughout Asia and into Europe and the United States. The volume of data is growing exponentially, providing not only challenges but also the clear opportunity to understand and treat diseases in ways not previously considered. Harnessing the knowledge within the data in a successful way can provide researchers and clinicians with new ideas for therapies while avoiding repeats of failed experiments. This knowledge transfer from research into clinical care is at the heart of a learning health system. Methods:The ARO Council wishes to form a worldwide complementary system for the benefit of all patients and investigators, catalyzing more efficient and innovative medical research processes. Thus, they have organized Global ARO Network Workshops to bring interested parties together, focusing on the aspects necessary to make such a global effort successful. One such workshop was held in Austin, Texas, in November 2017. Representatives from Japan, Taiwan, Singapore, Europe, and the United States reported on their efforts to encourage data sharing and to use research to inform care through learning health systems. Results:This experience report summarizes presentations and discussions at the Global ARO Network Workshop held in November 2017 in Austin, TX, with representatives from Japan, Korea, Singapore, Taiwan, Europe, and the United States. Themes and recommendations to progress their efforts are explored. Standardization and harmonization are at the heart of these discussions to enable data sharing. In addition, the transformation of clinical research processes through disruptive innovation, while ensuring integrity and ethics, will be key to achieving the ARO Council goal to overcome diseases such that people not only live longer but also are healthier and happier as they age. Conclusions:The achievement of global learning health systems will require further exploration, consensus-building, funding aligned with incentives for data sharing, standardization, harmonization, and actions that support global interests for the benefit of patients

"The United States Food and Drug Administration: Its role, authority, history, harmonization activities, and cooperation with the European Union."

The purpose of this article is to provide background about the United States Food and Drug Administration (FDA). The article will focus particularly upon the agency's authority, its place in the United States system, and its history as a domestic institution and as a participant in international activities. Finally, the article summarizes principal areas of regulatory cooperation with the European Union in the foods area and outlines future areas of cooperation. The article may be of interest to counterparts in other countries, confronted with such food safety issues - particularly the recent evidence that humans might develop a variant of a fatal neurological disease (Creutzfeld-Jakob disease) as a result of eating beef from cattle afflicted with bovine spongiform encephalopathy (BSE)

A story about standardization for design of glass works

This contribution attempts to give an overview of the European standardization framework which is related to the design and calculation of glass works in buildings. The different work levels, institutions, technical committees and workgroups, and the various types of documents and their statute will be introduced, explaining the difference between draft, experimental and final standards, between harmonized, support and design standards, the general and particular meaning of harmonization and implementation. The standardization framework is explained firstly from the point of view of European standardization policy and history, and secondly regarding the standardization framework in Belgium. In particular, an attempt is made to highlight some particularities existing in harmonization efforts of design methods and codes for glass works

INTERNATIONAL TRADE IN THE FOOD SECTOR AND ENVIRONMENTAL QUALITY, HEALTH, AND SAFETY: A SURVEY OF POLICY ISSUES

International Relations/Trade,

Bandwagon or Barriers? The Role of Standards in the European and American Marketplace. Working Paper #1, November 1997

Industrial Standards - a highly technical and even obscure topic to many scholars and policy-makers - are crucial in shaping market access and conditions. They act as non-tariff barriers (NTBs) and may affect relations between governments and businesses. The paper examines the evolution of EU policy toward standards and evaluates recent efforts to foster greater cooperation between the EU and the US in reducing trade inhibiting of industrial standards