The Resource Food and drug regulation in an era of globalized markets, edited by Sam F. Halabi

Food and drug regulation in an era of globalized markets, edited by Sam F. Halabi

Label
Food and drug regulation in an era of globalized markets
Title
Food and drug regulation in an era of globalized markets
Statement of responsibility
edited by Sam F. Halabi
Contributor
Editor
Subject
Language
eng
Summary
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
Cataloging source
NhCcYBP
Dewey number
344.04/23
Index
index present
LC call number
K3636
LC item number
.F66 2015
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
NLM call number
QV 33.1
http://library.link/vocab/relatedWorkOrContributorName
  • Halabi, Sam F.
  • ProQuest (Firm)
http://library.link/vocab/subjectName
  • Drugs
  • Pharmacy
  • Food law and legislation
  • Legislation, Drug
Label
Food and drug regulation in an era of globalized markets, edited by Sam F. Halabi
Link
https://ebookcentral.proquest.com/lib/umanitoba/detail.action?docID=2197878
Instantiates
Publication
Copyright
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Clinical Trials: Reducing Costs, Speeding Development: New Approaches to Patient Recruitment, Study Design, and Settings
  • New Device Regulations---State Council Order No. 650
  • Registration and Filing Requirements
  • Clinical Trials
  • Increased Legal Penalties and Liabilities
  • Practical Tips
  • Acknowledgments
  • pt. II
  • Designing Optimal Regulatory Structures to Address Diversifying and Globalizing Sources of Food and Additives
  • 9.
  • Balance Between Regulation and Private-Sector Initiative in Securing Healthy and Sustainable Food
  • Supply Chain: How Are We Vulnerable and What Are Potential Solutions?
  • Adriana Selwyn
  • Introduction
  • Historical Context
  • Challenge: Supporting Healthy Diets and Environmental Sustainability
  • Narrow Scope of Nutrition Policy
  • Lack of Investment in Broad-Based Solutions
  • Relationship with the Private Sector
  • Limited Capacity to Enforce Laws
  • Way Forward
  • Foster New Models of Collaboration
  • Big (More and More) Data: Swim or Drown?
  • Embrace the Shift Toward Libertarian Paternalism
  • Enhance the Role of Government
  • Lever Core Capabilities of Companies
  • Build on 40 Years of Partnerships Between Unlikely Partners
  • Return Mobility to Cities Through Innovative Infrastructure Investments
  • Future
  • Conclusion
  • 10.
  • Divide and Confound: The Relationship Between Transparency, Public Health, and Regulatory Authority in the National Food System
  • Lisa Heinzerling
  • Conclusion
  • 11.
  • Global Administrative Law and the FDA's Collaborative Agreements with International Regulatory Partners
  • Sam F. Halabi
  • Food Safety Modernization Act and the Prioritization of International Regulatory Partnerships
  • International Agreements: Typologies and Objectives
  • Confidentiality Agreements
  • Statements of Cooperation or Intent
  • Exchanges of Letters
  • Memoranda of Understanding
  • Systems Recognition
  • 2.
  • Agreements Within Broader Bilateral Cooperative Partnerships
  • Agreements or Quasi-Treaties
  • Conclusion
  • 12.
  • Effective Regulation of Food Additives
  • The Pew Charitable Trusts
  • Pew's Approach
  • Pew's Findings
  • Conflicts of Interest
  • Lack of Information
  • FDA's Global Investigation and Enforcement Authority, Partnerships, and Priorities
  • Outdated Science
  • Missing Safety Deadlines
  • Pew's Recommendations
  • Close the GRAS Loophole
  • Modernize the FDA's Food Additive Science
  • Ensure That Existing Chemical Additives Are Safe
  • Establish a Fee-Based Funding Program
  • 13.
  • Protecting Consumers through New Regulations, Inspection, and Verification under the U.S. Food Safety Modernization Act
  • Chris Waldrop
  • Marc J. Scheineson
  • Introduction
  • Preventive Controls for Human Food
  • Produce Safety
  • Foreign Supplier Verification Program
  • Third-Party Certification Program
  • Enforcement and Funding of the FSMA
  • 14.
  • Evolving Role of the Codex Alimentarius Commission in Securing Consumer Protection in Globalized Food Markets
  • Aliza Y. Glasner
  • Infrastructure of the Codex Alimentarius Commission
  • Introduction
  • Brief History
  • Organizational Structure
  • Leadership
  • Codex Executive Committee
  • Codex Secretariat
  • Codex Subsidiary Bodies
  • Codex Session Procedures
  • Codex in Practice: A Brief Look at Some Global Challenges
  • Internal Design
  • Outside Influences
  • Adulteration, Misbranding, and GMPs
  • Other International Institutions
  • Industry
  • Codex in the Twenty-First Century
  • 15.
  • Emergence and Influence of Transnational Private Regulation of Food Safety
  • Ching-Fu Lin
  • Introduction
  • Development of TPR in Global Food Safety Governance
  • Global Sourcing, Local Consumption
  • Globalized Food Supply Chains and Outbreaks
  • FDA Establishment Inspections
  • Reputational Risks to the Food Industry
  • Public Distrust of Governmental Regulatory Reforms and a Shift of Responsibility
  • Strengths of TPR of Food Safety
  • Technical Expertise
  • Effective and Efficient Cross-Border Supply Chain Control
  • Regulatory Adaptability
  • Cooperative and Proactive Nature
  • Weaknesses of TPR of Food Safety
  • Agency-Client Relationship, Checklist Governance, and Second-Level Information Asymmetry
  • Legitimacy and Accountability Concerns
  • Machine generated contents note:
  • FDA Enforcement Instruments Related to Manufacturing
  • Distributional Impact (Small Farmers and Developing Countries)
  • Conclusion
  • Interactions Between TPR and National Authorities
  • Interactions Between TPR and International Organizations
  • Governance Through Constructive Interactions
  • Foreign Inspections
  • Conclusion
  • 3.
  • European Medicines Agency and the Regulation of Medicines in the European Union
  • Martin Harvey-Allchurch
  • Introduction
  • Approval of Drugs in Europe
  • European Medicines Agency: Its Role and Activities
  • EMA Support in the Early Stages of Drug Development
  • pt. I
  • Centralized Procedure at Work
  • Assessment overview
  • Single Assessment Report
  • Patients in the Scientific Review Process
  • Transparency and the Centralized Procedure
  • EMA-FDA Cooperation
  • Cooperation in the Product Life Cycle
  • Cooperation in Inspections
  • Benefits of International Cooperation
  • References
  • Governance, Regulation, and Vulnerabilities of Globalized Pharmaceutical Supply Chains
  • 4.
  • Human Clinical Trials and Drug Approvals: Transnational Issues
  • Shira N. Epstien
  • Introduction
  • Taking Clinical Trials Abroad
  • Overlapping Legal and Regulatory Requirements
  • Legal Landscape in the United States: FDA Oversight of Clinical Trials
  • Legal Landscape in the EU: EU Clinical Trial Directives and Regulation
  • International Legal Landscape: International Clinical Practice Standards
  • National and Local Legal Standards
  • 1.
  • Practical Considerations in Conducting Global Trials
  • Deciding Whether to Conduct the Foreign Clinical Trial Under an IND
  • Identifying Experienced Contractors and Contract Research Organizations
  • Managing Idiosyncratic Foreign Sites and Investigators
  • Conclusion
  • Further Reading
  • 5.
  • Falsified and Substandard Medicines in Globalized Pharmaceutical Supply Chains: Toward Actionable Solutions
  • Lawrence O. Gostin
  • Globalization's Influence on the Pharmaceutical Supply Chain
  • Addressing Emerging Challenges in the Pharmaceutical Product Development Ecosystem
  • Effects of the Global Market for Falsified and Substandard Medicines
  • Barriers to Global Solutions for the Problem of Falsified and Substandard Medicines
  • Combating Falsified and Substandard Medicines through Regulatory Cooperation
  • Conclusion
  • 6.
  • Regulatory Capacity in Low- and Middle-Income Countries: Lessons from the H1N1 Influenza Pandemic
  • John Monahan
  • Introduction
  • Pandemic Influenza: Background and Basics of Public Health System Response
  • Pandemic H1N1 and the Global Response
  • Jesse Goodman
  • Regulatory Barriers and Legal Barriers IMPACT Participation in the Global Response
  • Lack of Regulatory Capacity Stymies Efforts to Distribute Pandemic Vaccine after Legal Agreements Are Concluded
  • Role of Investment in Regulatory Capacity and the Effectiveness of the WHO Pandemic Influenza Preparedness Framework
  • Conclusion
  • 7.
  • Prime Minister Narendra Modi's Government and Its Impact on the Indian Pharmaceutical Sector
  • Vince Suneja
  • Introduction
  • Ministry of Health & Family Welfare
  • Ministry of Chemicals & Fertilizers
  • Introduction
  • Ministry of Science & Technology
  • Ministry of Commerce & Industry
  • Ministry of Finance
  • Emerging Patterns in the Pharmaceutical Regulatory Environment under the Modi Government
  • 8.
  • Regulatory Challenges for Medical Devices and Drugs Under the China Food and Drug Administration
  • Gordon B. Schatz
  • China's Political and Regulatory Goals: The Context for Drug and Device Regulation
  • Drugs
  • Patented and Generic Drugs
  • Approaches to Reduce Drug Development Costs and Speed Innovation
  • Registration
  • Clinical Trials
  • Manufacture and Sale of Drugs
  • Drugs That Have Been Licensed/Approved in Other Jurisdictions
  • Advertising
  • Anticorruption Compliance
  • Devices
  • Importing and Registering Medical Devices
  • Clinical Trials
  • Advertising Medical Devices
Dimensions
unknown
Extent
1 online resource.
File format
unknown
Form of item
online
Isbn
9780128025505
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Quality assurance targets
not applicable
Reformatting quality
unknown
Reproduction note
Electronic reproduction.
Sound
unknown sound
Specific material designation
remote
System control number
(NhCcYBP)EBC2197878
Label
Food and drug regulation in an era of globalized markets, edited by Sam F. Halabi
Link
https://ebookcentral.proquest.com/lib/umanitoba/detail.action?docID=2197878
Publication
Copyright
Antecedent source
unknown
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Clinical Trials: Reducing Costs, Speeding Development: New Approaches to Patient Recruitment, Study Design, and Settings
  • New Device Regulations---State Council Order No. 650
  • Registration and Filing Requirements
  • Clinical Trials
  • Increased Legal Penalties and Liabilities
  • Practical Tips
  • Acknowledgments
  • pt. II
  • Designing Optimal Regulatory Structures to Address Diversifying and Globalizing Sources of Food and Additives
  • 9.
  • Balance Between Regulation and Private-Sector Initiative in Securing Healthy and Sustainable Food
  • Supply Chain: How Are We Vulnerable and What Are Potential Solutions?
  • Adriana Selwyn
  • Introduction
  • Historical Context
  • Challenge: Supporting Healthy Diets and Environmental Sustainability
  • Narrow Scope of Nutrition Policy
  • Lack of Investment in Broad-Based Solutions
  • Relationship with the Private Sector
  • Limited Capacity to Enforce Laws
  • Way Forward
  • Foster New Models of Collaboration
  • Big (More and More) Data: Swim or Drown?
  • Embrace the Shift Toward Libertarian Paternalism
  • Enhance the Role of Government
  • Lever Core Capabilities of Companies
  • Build on 40 Years of Partnerships Between Unlikely Partners
  • Return Mobility to Cities Through Innovative Infrastructure Investments
  • Future
  • Conclusion
  • 10.
  • Divide and Confound: The Relationship Between Transparency, Public Health, and Regulatory Authority in the National Food System
  • Lisa Heinzerling
  • Conclusion
  • 11.
  • Global Administrative Law and the FDA's Collaborative Agreements with International Regulatory Partners
  • Sam F. Halabi
  • Food Safety Modernization Act and the Prioritization of International Regulatory Partnerships
  • International Agreements: Typologies and Objectives
  • Confidentiality Agreements
  • Statements of Cooperation or Intent
  • Exchanges of Letters
  • Memoranda of Understanding
  • Systems Recognition
  • 2.
  • Agreements Within Broader Bilateral Cooperative Partnerships
  • Agreements or Quasi-Treaties
  • Conclusion
  • 12.
  • Effective Regulation of Food Additives
  • The Pew Charitable Trusts
  • Pew's Approach
  • Pew's Findings
  • Conflicts of Interest
  • Lack of Information
  • FDA's Global Investigation and Enforcement Authority, Partnerships, and Priorities
  • Outdated Science
  • Missing Safety Deadlines
  • Pew's Recommendations
  • Close the GRAS Loophole
  • Modernize the FDA's Food Additive Science
  • Ensure That Existing Chemical Additives Are Safe
  • Establish a Fee-Based Funding Program
  • 13.
  • Protecting Consumers through New Regulations, Inspection, and Verification under the U.S. Food Safety Modernization Act
  • Chris Waldrop
  • Marc J. Scheineson
  • Introduction
  • Preventive Controls for Human Food
  • Produce Safety
  • Foreign Supplier Verification Program
  • Third-Party Certification Program
  • Enforcement and Funding of the FSMA
  • 14.
  • Evolving Role of the Codex Alimentarius Commission in Securing Consumer Protection in Globalized Food Markets
  • Aliza Y. Glasner
  • Infrastructure of the Codex Alimentarius Commission
  • Introduction
  • Brief History
  • Organizational Structure
  • Leadership
  • Codex Executive Committee
  • Codex Secretariat
  • Codex Subsidiary Bodies
  • Codex Session Procedures
  • Codex in Practice: A Brief Look at Some Global Challenges
  • Internal Design
  • Outside Influences
  • Adulteration, Misbranding, and GMPs
  • Other International Institutions
  • Industry
  • Codex in the Twenty-First Century
  • 15.
  • Emergence and Influence of Transnational Private Regulation of Food Safety
  • Ching-Fu Lin
  • Introduction
  • Development of TPR in Global Food Safety Governance
  • Global Sourcing, Local Consumption
  • Globalized Food Supply Chains and Outbreaks
  • FDA Establishment Inspections
  • Reputational Risks to the Food Industry
  • Public Distrust of Governmental Regulatory Reforms and a Shift of Responsibility
  • Strengths of TPR of Food Safety
  • Technical Expertise
  • Effective and Efficient Cross-Border Supply Chain Control
  • Regulatory Adaptability
  • Cooperative and Proactive Nature
  • Weaknesses of TPR of Food Safety
  • Agency-Client Relationship, Checklist Governance, and Second-Level Information Asymmetry
  • Legitimacy and Accountability Concerns
  • Machine generated contents note:
  • FDA Enforcement Instruments Related to Manufacturing
  • Distributional Impact (Small Farmers and Developing Countries)
  • Conclusion
  • Interactions Between TPR and National Authorities
  • Interactions Between TPR and International Organizations
  • Governance Through Constructive Interactions
  • Foreign Inspections
  • Conclusion
  • 3.
  • European Medicines Agency and the Regulation of Medicines in the European Union
  • Martin Harvey-Allchurch
  • Introduction
  • Approval of Drugs in Europe
  • European Medicines Agency: Its Role and Activities
  • EMA Support in the Early Stages of Drug Development
  • pt. I
  • Centralized Procedure at Work
  • Assessment overview
  • Single Assessment Report
  • Patients in the Scientific Review Process
  • Transparency and the Centralized Procedure
  • EMA-FDA Cooperation
  • Cooperation in the Product Life Cycle
  • Cooperation in Inspections
  • Benefits of International Cooperation
  • References
  • Governance, Regulation, and Vulnerabilities of Globalized Pharmaceutical Supply Chains
  • 4.
  • Human Clinical Trials and Drug Approvals: Transnational Issues
  • Shira N. Epstien
  • Introduction
  • Taking Clinical Trials Abroad
  • Overlapping Legal and Regulatory Requirements
  • Legal Landscape in the United States: FDA Oversight of Clinical Trials
  • Legal Landscape in the EU: EU Clinical Trial Directives and Regulation
  • International Legal Landscape: International Clinical Practice Standards
  • National and Local Legal Standards
  • 1.
  • Practical Considerations in Conducting Global Trials
  • Deciding Whether to Conduct the Foreign Clinical Trial Under an IND
  • Identifying Experienced Contractors and Contract Research Organizations
  • Managing Idiosyncratic Foreign Sites and Investigators
  • Conclusion
  • Further Reading
  • 5.
  • Falsified and Substandard Medicines in Globalized Pharmaceutical Supply Chains: Toward Actionable Solutions
  • Lawrence O. Gostin
  • Globalization's Influence on the Pharmaceutical Supply Chain
  • Addressing Emerging Challenges in the Pharmaceutical Product Development Ecosystem
  • Effects of the Global Market for Falsified and Substandard Medicines
  • Barriers to Global Solutions for the Problem of Falsified and Substandard Medicines
  • Combating Falsified and Substandard Medicines through Regulatory Cooperation
  • Conclusion
  • 6.
  • Regulatory Capacity in Low- and Middle-Income Countries: Lessons from the H1N1 Influenza Pandemic
  • John Monahan
  • Introduction
  • Pandemic Influenza: Background and Basics of Public Health System Response
  • Pandemic H1N1 and the Global Response
  • Jesse Goodman
  • Regulatory Barriers and Legal Barriers IMPACT Participation in the Global Response
  • Lack of Regulatory Capacity Stymies Efforts to Distribute Pandemic Vaccine after Legal Agreements Are Concluded
  • Role of Investment in Regulatory Capacity and the Effectiveness of the WHO Pandemic Influenza Preparedness Framework
  • Conclusion
  • 7.
  • Prime Minister Narendra Modi's Government and Its Impact on the Indian Pharmaceutical Sector
  • Vince Suneja
  • Introduction
  • Ministry of Health & Family Welfare
  • Ministry of Chemicals & Fertilizers
  • Introduction
  • Ministry of Science & Technology
  • Ministry of Commerce & Industry
  • Ministry of Finance
  • Emerging Patterns in the Pharmaceutical Regulatory Environment under the Modi Government
  • 8.
  • Regulatory Challenges for Medical Devices and Drugs Under the China Food and Drug Administration
  • Gordon B. Schatz
  • China's Political and Regulatory Goals: The Context for Drug and Device Regulation
  • Drugs
  • Patented and Generic Drugs
  • Approaches to Reduce Drug Development Costs and Speed Innovation
  • Registration
  • Clinical Trials
  • Manufacture and Sale of Drugs
  • Drugs That Have Been Licensed/Approved in Other Jurisdictions
  • Advertising
  • Anticorruption Compliance
  • Devices
  • Importing and Registering Medical Devices
  • Clinical Trials
  • Advertising Medical Devices
Dimensions
unknown
Extent
1 online resource.
File format
unknown
Form of item
online
Isbn
9780128025505
Level of compression
unknown
Media category
computer
Media MARC source
rdamedia
Media type code
c
Quality assurance targets
not applicable
Reformatting quality
unknown
Reproduction note
Electronic reproduction.
Sound
unknown sound
Specific material designation
remote
System control number
(NhCcYBP)EBC2197878

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