Sam F Halabi - Böcker

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today's markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India.

From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges.

Based on the 2014 O'Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation.

Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce

The 2014-2015 Ebola outbreak in West Africa shocked the world with its devastation and its rapid migration to multiple continents. As the systems meant to respond to this sort of epidemic failed, the disease exposed not just weaknesses in international infectious disease surveillance and management, but the failures of governments, humanitarian organizations, and international institutions to handle the legal, ethical, and economic questions that arose with an event of this scale. Global Management of Infectious Disease After Ebola unites the insights of Ebola's first responders with those the world's foremost experts in law, economics, vaccine development, and global migration to identify missed opportunities from the Ebola crisis -- and to apply these lessons to emerging infectious disease threats. Framed with critical discussions of both the global health financing infrastructures that precipitated the response and the ethical and human rights dilemmas that resulted from it, this volume is much more than postmortem to an outbreak: it is a vital, sometimes damning examination of where we've been and where we're going in the face of emerging infectious diseases.

In economic sectors crucial to human welfare - agriculture, education, and medicine - a small number of firms control global markets, primarily by enforcing intellectual property (IP) rights incorporated into trade agreements made in the 1980s onward. Such rights include patents on seeds and medicines, copyrights for educational texts, and trademarks in consumer products. According to conventional wisdom, these agreements likewise ended hopes for a 'New International Economic Order,' under which wealth would be redistributed from rich countries to poor. Sam F. Halabi turns this conventional wisdom on its head by demonstrating that the New International Economic Order never faded, but rather was redirected by other treaties, formed outside the nominally economic sphere, that protected poor countries' interests in education, health, and nutrition and resulted in redistribution and regulation. This illuminating work should be read by anyone seeking a nuanced view of how IP is shaping the global knowledge economy.

In the global infectious-disease research community, there has long been uncertainty about the conditions under which biological resources may be studied or transferred out of countries. This work examines the reasons for that uncertainty and shows how global biomedical research has been shaped by international disputes over access to biological resources. Bringing together government leaders, World Health Organization officials, and experts in virology, wildlife biology, clinical ethics, technology transfer, and international law, the book identifies the critical problems - and implications of these problems - posed by negotiating for access and sharing benefits, and proposes solutions to ensure that biomedical advances are not threatened by global politics. Written in accessible, non-technical language, this work should be read by anyone who sees global health and biomedical research as a priority for international lawmakers.

In the global infectious-disease research community, there has long been uncertainty about the conditions under which biological resources may be studied or transferred out of countries. This work examines the reasons for that uncertainty and shows how global biomedical research has been shaped by international disputes over access to biological resources. Bringing together government leaders, World Health Organization officials, and experts in virology, wildlife biology, clinical ethics, technology transfer, and international law, the book identifies the critical problems - and implications of these problems - posed by negotiating for access and sharing benefits, and proposes solutions to ensure that biomedical advances are not threatened by global politics. Written in accessible, non-technical language, this work should be read by anyone who sees global health and biomedical research as a priority for international lawmakers.