Pathway to Global Product Safety and Quality
Pathway to Global Product Safety and Quality

Author: Margaret A. Hamburg

Publisher: DIANE Publishing

Published: 2012-10-07

Total Pages: 37

ISBN-13: 1437988377

DOWNLOAD EBOOK

This report presents a new strategy by the Food and Drug Admin. (FDA) to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain. The agency is planning to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change: (1) The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality; (2) The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets; (3) The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and IT; (4) The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. The report also discusses trends expected to be seen worldwide in upcoming years which have caused FDA to develop its new strategy. Figures. This is a print on demand report.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-09-03

Total Pages: 366

ISBN-13: 030922408X

DOWNLOAD EBOOK

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

PDUFA V
PDUFA V

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health

Publisher:

Published: 2012

Total Pages: 184

ISBN-13:

DOWNLOAD EBOOK

Drugs
Drugs

Author: Rick Ng

Publisher: John Wiley & Sons

Published: 2015-04-28

Total Pages: 554

ISBN-13: 1118907191

DOWNLOAD EBOOK

Prozesse, die für die Marktreife von Medikamenten erforderlich sind. Behandelt werden unter anderem vorklinische Studien, klinische Studien am Menschen, regulatorische Kontrollen und sogar die Herstellungsprozesse von pharmazeutischen Produkten. Nach einen prägnanten und leicht verständlichen Vorstellung der grundlegenden Konzepte werden die Zielstrukturen und der Entwicklungsprozess von klein- und großmolekularen Arzneimittel präsentiert. In der 3. aktualisiertenAuflage ist dieses Fachbuch noch ansprechender. Neben den neuesten Entwicklungen werden die einzelnen Themen noch umfassender erläutert und durch zusätzliche Materialien und Fallstudien für den Einsatz an Hochschulen und Universitäten ergänzt. Die Biotechnologie ist ein dynamisches Fachgebiet. Forschung und Entwicklung, klinische Prüfungen, Herstellungsverfahren und regulatorische Prozesse unterliegen ständigen Veränderungen. Biotechnologie und Biowissenschaften sind vom globalem Interesse. Daher besetzt dieses Fachbuch eine Nische und erhält immer wieder gute Kritiken. Die überarbeitete 3. Auflage sorgt für anhaltende Relevanz und Nutzen für die Leser.

Materials and Manufacturing Capabilities for Sustaining Defense Systems
Materials and Manufacturing Capabilities for Sustaining Defense Systems

Author: National Research Council

Publisher: National Academies Press

Published: 2013-04-29

Total Pages: 87

ISBN-13: 0309267579

DOWNLOAD EBOOK

The Standing Committee on Defense Materials Manufacturing and Infrastructure (DMMI) conducted a workshop on July 23-24, 2012, to share information and gather perspectives on issues concerning Materials and Manufacturing Capabilities for Sustaining Defense Systems. This workshop, held at the headquarters building of the National Academies, 2101 Constitution Avenue N.W., Washington D.C., was conducted according to the procedures of the National Research Council (NRC) for a convening activity. That is, all workshop participants-including presenters, members of the DMMI standing committee, Reliance 21, invited guests, and visitors-spoke as individuals, and no overall findings, conclusions, or recommendations were developed during or as a result of the workshop. All statements and views summarized in this publication are attributable only to those individuals who expressed them. It is worth noting that the sponsor, Reliance 21, is a Department of Defense group of professionals that was established to enable the DOD science and technology (S&T) community to work together to enhance Defense S&T programs, eliminate unwarranted duplication, and strengthen cooperation among the military services and other DOD agencies. The DMMI standing committee named a workshop planning group to develop the workshop agenda and decide on invited guests and presenters, in accordance with the statement of task approved by the Governing Board of the NRC. The planning group also consulted with the Reliance 21 materials and processing community of interest. The presentations and discussions during the workshop are summarized sequentially in the main part of this report. As an aid to readers, nine themes have been identified by the author that recurred in multiple presentations and discussions. Materials and Manufacturing Capabilities for Sustaining Defense Systems: Summary of a Workshop explains these nine themes and summarizes the two day workshop.

Food Safety Regulatory Compliance
Food Safety Regulatory Compliance

Author: Preston W. Blevins

Publisher: CRC Press

Published: 2012-11-16

Total Pages: 342

ISBN-13: 1439849587

DOWNLOAD EBOOK

The global sourcing of ingredients has created complex supply chains, significant management challenges, and additional regulatory compliance requirements. This places tremendous pressure on food manufacturers, many of whom lack the knowledge, concepts, techniques, and procedures to comply with these increased requirements. Providing a roadmap for

Foodborne Illness: Latest Threats and Emerging Issues, an Issue of Infectious Disease Clinics
Foodborne Illness: Latest Threats and Emerging Issues, an Issue of Infectious Disease Clinics

Author: David Acheson

Publisher: Elsevier Health Sciences

Published: 2013-09-25

Total Pages: 220

ISBN-13: 0323188583

DOWNLOAD EBOOK

Food Borne Illness is a common, costly, yet preventable public health problem. This issue of the Infectious Disease Clinics covers the most common food borne pathogens, along with articles that include indentifying, diagnosing, and treating food borne illness. The issue also covers food borne illness in special populations, as well as long term complications associated with food borne illness.

Red, White & Blue-Collar
Red, White & Blue-Collar

Author: Jonathan E. Gibson

Publisher: WestBow Press

Published: 2012-09-19

Total Pages: 128

ISBN-13: 1449759858

DOWNLOAD EBOOK

America, we are at a pivotal point in time. Our priorities are not in order, and our future is on the back burner. Greedy and proud, our self-righteous way of living has flushed our ethics down the drain, and it seems weve forgotten what this country was founded on. The path we are on as a nation is a dark and dangerous one that will ultimately lead to a land that is dry and desolate. America is on the brink of a moral, economic, and military collapse, and if we choose to not act upon our rights as US citizens, our country may be lost forever. Fortunately, though, there is hope! We each have a voice and the freedom with which to make ourselves heard. We each have a choice in every decision to be made as a nation. We each have the ability to make things change. Together we can reclaim our sweet land of liberty. This should be and can be a turning point for America, but we must unite to make it happen. Putting aside petty differences and aiming for common goals, we can change the future of America. A new day has dawned, and our time is now! This book will put a fire beneath your seat and rev up your spirit. It will make you want to revive the American dream for yourself and your fellow man. It will offer hope to the hopeless, motivation to those lacking, and help to those who have lost faith in their country.