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Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

Appendix E

Meeting Agendas

MARCH 2-3, 2011
MEETING 1—AGENDA

Keck Building
500 Fifth Street NW
Washington, DC 20001

Day 1 Goals:

1.   Introduce the National Academies’ study process

2.   Discuss bias and conflict of interest

3.   Fully understand this study’s statement of task

4.   Learn about the capacity and priorities of the FDA

DAY ONE: WEDNESDAY, MARCH 2, 2011
KECK BUILDING, ROOM 109

8:30 Breakfast Available

9:00-11:00

SESSION 1—CLOSED
IOM COMMITTEE PROCESS AND CHARGE TO COMMITTEE

Objectives: To review the National Academies’ study process that includes a bias and conflict-of-interest discussion; to discuss the role of the committee in addressing the statement of task; and to ensure the committee understands its statement of task.

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
11:00-11:10 Break

SESSION 2—OPEN
QUESTIONS ON STATEMENT OF TASK

11:10-11:30 Project Timeline and Statement of Task Sponsor Representative Introductions Jim Riviere, Committee Chair
11:30-12:15 Questions to Sponsor
 

Mary Lou Valdez, Associate Commissioner for International Programs, FDA

 

Kate Bond, Associate Director for Technical Cooperation/Capacity-Building, FDA

12:15 Lunch

SESSION 3—OPEN
THE FDA PERSPECTIVE

Objective: To learn about the FDA’s current capacity and its international work.

12:45 Welcome the Public and Introduce Commissioner Hamburg Jim Riviere, Committee Chair
12:45-1:05 Keynote Address: Why is this study important to the FDA? Margaret Hamburg, Commissioner, FDA
1:05-1:25 Questions
1:25-2:30 What is the capacity of the FDA Centers? What are the key issues they face in international work?
 

Deb Autor, Director, FDA Center for Drug Evaluation and Research

 

Karen Midthun, Director, FDA Center for Biologics Evaluation and Research

 

Lillian Gill, Senior Associate Director, FDA Center for Devices and Radiological Health

 

Don Kraemer, Acting Deputy Director for Operations, FDA Center for Food Safety and Applied Nutrition

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
2:30-2:50

How is the FDA already working to build regulatory systems abroad?

 

Mac Lumpkin, FDA Deputy Commissioner for International Programs

2:50-3:20 Panel discussion with presenters
  Jane Henney, Moderator
3:20-3:35 Break

SESSION 4—OPEN
CORE ELEMENTS OF REGULATORY SYSTEMS

Objective: To identify the core elements of regulatory systems in developing countries and what gaps exist in these systems.

3:35-4:00 Core Elements of Medical Device Regulatory Systems in Developing Countries
 

Michael Gropp, Vice President, Global Regulatory Strategy, Medtronic

 

Greg Kalbaugh, Director and Counsel, U.S. Chamber of Commerce, U.S.-India Business Council

4:00-4:25 Core Elements of Food Regulatory Systems in Developing Countries
 

Ernesto Enriquez, Ministry of Health, Mexico

 

Paul B. Young, Director, Chemical Analysis Operations, Waters Corporation

4:25-4:55

Core Elements of Drug and Biologics Regulatory Systems in Developing Countries

 

Jose Luis Di Fabio, Area Manager, PAHO

 

Ekopimo Okon Ibia, Director and U.S. Regulatory Policy Lead, Global Regulatory Strategy, Policy, and Safety, Merck & Co., Inc.

4:55-5:45

What are the gaps in the systems? A panel discussion with presenters

 

Martha Brumfield, Moderator

5:45 Adjourn
Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

DAY TWO: THURSDAY, MARCH 3, 2011
KECK BUILDING, ROOM 110

Day 2 Goals:

1.   Learn about existing recommendations and the obstacles to implementing them

2.   Make a strategy for how to tackle the statement of task

3.   Discuss how to structure the final report

4.   Begin considering possible recommendation topics

8:00 Breakfast Available

SESSION 5—CLOSED
REACTIONS TO PRESENTATIONS AND PLANNING TRAVEL

Objective: To discuss the presentations and plan the travel meetings.

SESSION 6—OPEN
EXISTING RECOMMENDATIONS AND OBSTACLES TO IMPLEMENTATION

Objective: To learn what recommendations have already been made to strengthen regulatory systems and what obstacles exist to implementing these recommendations.

10:10-10:30 The Global Harmonization Task Force
 

Michael Gropp, Vice President, Global Regulatory Strategy, Medtronic

10:30-10:50 Promoting the Quality of Medicines
 

Patrick Lukulay, Director, Promoting the Quality of Medicines Program, U.S. Pharmacopeia

10:50-11:10 Capacity Building and the Partnership Training Institute Network
 

Paul B. Young, Director, Chemical Analysis Operations, Waters Corporation

11:10-11:30 The Global Food Safety Initiative
 

Mike Robach, Vice President Corporate Food Safety and Regulatory Affairs, Cargill

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
11:30-11:50

The International Medical Products Anti-Counterfeiting Taskforce

 

Howard Zucker, Senior Advisor, Division of Global Health & Human Rights, Massachusetts General Hospital

11:50-12:30 Lunch
12:30-1:15 What prevents implementing recommendations? A panel discussion with presenters
  Tom Bollyky, Moderator

SESSION 7—CLOSED
DISCUSSION AND STRATEGY FOR THE WAY FORWARD

Objective: To review the previous session, begin discussing recommendations, and give feedback on the meeting.

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

TRAVEL MEETING 1—AGENDA

DAY ONE: WEDNESDAY MAY 11, 2011
CHINESE ACADEMY OF ENGINEERING, BEIJING

SESSION ONE
ORIENTATION

Objective: To explain the study and the purpose of our visit, to exchange introductions with representatives of the Chinese government, and to explain the IOM study process.

9:00-9:15 Welcome
  Jim Riviere, Committee Chair
9:15-9:30 Introductions
9:30-9:50 Institute of Medicine Process
  Patrick Kelley, Board Director

SESSION TWO
FDA’S CHINA PRESENCE

Objective: To learn about the FDA’s work in China.

9:50-10:10 The FDA in China
Christopher Hickey, Country Director, FDA
10:10-10:25 Questions

SESSION THREE
REGULATOR PANEL

Objective: To how learn about Chinese regulators work and the key issues they face.

10:25-12:00 Panel Discussion, Junshi Chen, Moderator
Yinglian Hu, Professor, National Academy of Governance
 

Ma Yong, Secretary General, China National Food Industry Association

 

Geng Xiao, Director, Columbia Global Center

 

Chen Rui, Deputy Director General, MOH

 

Gao Fang, Deputy Director General, Ministry of Agriculture

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
12:00-1:00 Lunch

SESSION FOUR
REGULATED INDUSTRY PANEL

Objective: To learn how regulated industry works with national, regional, and foreign regulators, how they manage their supply chains, how able they are to comply with standards and harmonization efforts.

1:00-2:30 Panel Discussion, Martha Brumfield, Moderator
 

Wen Chang, Vice Chairwoman, China Pharmaceutical Quality Association

 

Sun Wei, Director of Scientific and Regulatory Affairs, Coca-Cola China

 

Steve Yang, VP, Head of R&D, Asia and Emerging Markets, AstraZeneca

 

Li Yu, Scientific and Regulatory Affairs, MARS China

 

Penggui Zai, Food Regulatory Affairs Manager, Wahaha Group

 

Libin Zhao, Department of International Regulatory Affairs, Tianjin Tasly Institute

2:30-2:40 Discussion Response
Philip Chen, Director, China Health Law Initiative
2:40-2:50 Break

SESSION FOUR
DONOR AND INTERNATIONAL ORGANIZATION PANEL

Objective: To explore how international organizations are working on health systems and infrastructure building, and to understand the role of a strong regulatory framework for health, agriculture and economic development.

3:00-4:30 Panel discussion, Jake Chen, Moderator
  Gerd Fleischer, Food Safety, GIZ
 

Zuo Shuyan, Expanded Program on Immunization, WHO

 

Peter Karim Ben Embarek, Team Leader Food Safety and Nutrition, WHO

 

Jiankang Zhang, Country Program Leader, PATH

4:30-4:40 Discussion Response
Geng Xiao, Director, Columbia Global Center
Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

DAY TWO: THURSDAY, MAY 12, 2011
CHINESE ACADEMY OF ENGINEERING, BEIJING

7:30-8:15 Working breakfast for committee and staff at Intercontinental Hotel

image

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

DAY THREE: FRIDAY MAY 13, 2011
CHINA HOTEL, GUANGZHOU

SESSION ONE
ORIENTATION

8:30-8:45 Welcome and introductions
Jim Riviere, Committee Chair
8:45-9:00 Institute of Medicine Process
Patrick Kelley, Board Director

SESSION TWO A
FOOD AND DRUG REGULATION

9:00-10:00 Panel Discussion, Jake Chen, Moderator
 

Benny Liu, Director Fresh Development, Wal-Mart China

 

Ke Ding, Deputy Director Drug Discovery, Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences

 

Qian Cheng, Deputy Director, South China Center for Innovative Pharmaceuticals

SESSION TWO B
GUANGDONG FDA

9:40-10:00 Travel to Guangdong FDA
10:00-12:30 Discussion
Chris Hickey, Country Director, FDA
Guangdong Provincial Regulators

SESSION THREE
WRIGLEY FACTORY: SUPPLY CHAIN CASE STUDY

10:10-11:00 Travel to Wrigley Factory
11:00-12:00 Factory tour
12:00-1:00 Lunch
1:00-2:00

Closing remarks, Thanh Nguyen, Regional Quality Director Asia-Pacific Supply Chain, Wrigley

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

SESSION THREE
THE FDA PERSPECTIVE
CHINA HOTEL, GUANGZHOU

3:30-5:00 Panel Discussion, Corrie Brown, Moderator
  Dennis Doupnik, Investigator, FDA
  Dennis Hudson, Consumer Safety Officer, FDA
  WeiHua Evid Liu, FDA

TRAVEL MEETING 2—AGENDA

DAY ONE: MONDAY, JUNE 20, 2011
UNIVERSITY OF SAO PAULO, SCHOOL OF PUBLIC HEALTH, PROFESSOR EDMUNDO JUAREZ ROOM AVENIDA DOUTOR ARNALDO, 715, SAO PAULO

SESSION ONE
ORIENTATION

Objective: To explain the study and the purpose of our visit and to explain the IOM study process.

9:00-9:05 Welcome
 

Helena Ribeiro, Director, University of Sao Paulo School of Public Health

9:05-9:15 Study Overview
Jim Riviere, Committee Chair
9:15-9:25 IOM Process
Gillian Buckley, Study Director

SESSION TWO
FDA’S LATIN AMERICA PRESENCE

Objective: To learn about the FDA’s work in Latin America.

9:25-9:45 The FDA in Latin America
 

Ana Maria Osorio, Assistant Regional Director—Latin America, U.S. FDA

9:45-10:00 Questions
Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
10:05-10:20 Break

SESSION THREE
REGULATORS’ ROUNDTABLE

Objective: To gain a better understanding of how Latin American regulators work and the key issues they face.

10:20-11:20 Roundtable Discussion, Carlos Morel, Moderator
 

Renato Spindel, Director, Scult Health Planning and Consultancy Ltda.

 

Amelia Villar, Consultant in Essential Medicine and Biologicals, PAHO

11:20-11:30 Discussion Response
 

Terezinha de Jesus Andreolli Pinto, Professor, University of Sao Paulo School of Pharmaceutical Sciences

11:30-12:40 Roundtable Discussion, Andy Stergachis, Moderator
 

Adriana Valenzuela, Head of International Affairs, Division of Livestock Service, Chile Ministry of Agriculture

 

Marta H. Taniwaki, Science Researcher, State Food Technology Institute

 

Claudio Poblete, Professor of Livestock Legislation, Universidad Mayor School of Veterinary Medicine

 

Hector Lazaneo, Division Director, Ministry of Livestock, Agriculture and Fisheries, Uruguay

12:40-1:40 Lunch

SESSION FOUR
REGULATED INDUSTRY ROUNDTABLE

Objective: To learn how regulated industry works with national, regional, and foreign regulators, how they manage their supply chains, how able they are to comply with standards and harmonization efforts, and what incentives could help them comply with standards and harmonization efforts.

1:40-2:45 Roundtable Discussion, Clare Narrod, Moderator
 

Rosane Cuber Guimaraes, Good Practices Manager, Department of Quality Assurance, Bio-Manguinhos/Fiocruz

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
 

Lauro Moretto, Executive Vice-President, Association of the Pharmaceutical Industry in the State of Sao Paulo

 

Carlos Alberto Goulart, Executive President, Brazilian Association for Importers of Medical Equipment, Products and Supplies

 

Debora Germano, Associate Director of Regulatory Affairs, Pfizer Brazil

2:45-3:05

Discussion Response

 

Silvia Storpirtis, Associate Professor, University of Sao Paulo School of Pharmaceutical Sciences

 

Marco Antonio Stephano, Professor, University of Sao Paulo School of Pharmaceutical Sciences

3:05-3:20

Break

SESSION FIVE
INTERNATIONAL AND DONOR ORGANIZATION ROUNDTABLE

Objective: To explore how international organizations are working on health systems and infrastructure building, and to understand the role of a strong regulatory framework for health, agriculture, and economic development.

3:20-4:30 Roundtable Discussion, Tom Bollyky, Moderator
Raymond Dugas, Regional Food Safety Advisor, PAHO
 

Sergio Nishioka, Scientist, WHO, Department of Immunization, Vaccines and Biologicals

 

Ana Marisa Cordero Pena, Agricultural Health and Food Safety Specialist, Inter-American Institute for Cooperation on Agriculture

5:00

Adjourn

6:30-8:00

Working dinner for committee members and staff

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

DAY TWO: TUESDAY, JUNE 21, 2011
UNIVERSITY OF SAO PAULO, CHOOL OF PBULIC HEALTH—SAO PAULO BRAZIL

7:30-8:15 Working breakfast for committee and staff at the Sofitel

image

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

TRAVEL MEETING 3—AGENDA

THURSDAY, JUNE 23, 2011
ACADEMY OF SCIENCE OF SOUTH AFRICA FIRST FLOOR, BLOCK A, THE WOODS, 41 DEHAVILLAND CRESCENT, PERSEQUOR PARK, PRETORIA

SESSION ONE
ORIENTATION

Objective: To explain the study and the purpose of our visit to the participants and to explain the IOM study process.

9:00-9:05 Welcome
 

Nthabiseng Toale, Program Manager, Academy of Science of South Africa

9:05-9:15 Study Overview
  Jim Riviere, IOM Committee Chair
9:15-9:25 IOM Process
  Patricia Cuff, IOM Senior Program Officer
9:25-9:35 Questions

SESSION TWO
FDA’S AFRICA PRESENCE

Objective: To learn about the U.S. FDA’s work in Africa.

9:35-9:45 The FDA in Africa
 

Beverly Corey, Senior Regional Advisor for Africa, U.S. FDA

9:45-9:55 Questions

SESSION THREE
REGULATORS’ ROUNDTABLE

Objective: To understand how African regulators work and the key issues they face.

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
9:55-11:10 Roundtable Discussion, Andy Stergachis, Moderator
 

Margareth Ndomondo-Sigonda, Pharmaceutical Coordinator, New Partnership for Africa’s Development, African Union

 

Derek Litthauer, Director, National Control Laboratory for Biological Products, University of the Free State

 

Robert Crookes, Acting Medical Director, South African National Blood Service

11:10-11:20 Discussion Response
 

Nicholas Crisp, Managing Director, Benguela Health Pty Ltd.

11:20-11:35 Break
11:35-12:35 Roundtable Discussion, Clare Narrod, Moderator
 

Malose Daniel Matlala, Deputy Director Food Control, Department of Health

 

Pieter Truter, Technical Specialist, National Regulator for Compulsory Specifications

 

Raymond Wigenge, Director of Food Safety, Tanzania Food and Drugs Authority

 

Sarah Olembo, Technical Expert Sanitary and Phytosanitary Issues and Food Safety, African Union Commission

12:35-12:45 Discussion Response
  Nick Starke, Chairman, International Life Sciences Institute
12:45-1:45 Lunch

SESSION FOUR
REGULATED INDUSTRY ROUNDTABLE

Objective: To learn how regulated industry works with national, regional, and foreign regulators, how they manage their supply chains, how able they are to comply with standards and harmonization efforts, and what incentives could help them comply with standards and harmonization efforts.

1:45-3:00 Roundtable Discussion, Tom Bollyky, Moderator
 

Elaine Alexander, Executive Director, South Africa Table Grape Industry

 

Maeve Magner, Chief Executive, RTT

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
 

Skhumbuzo Ngozwana, President, South African Generic Manufacturers’ Association

 

Kirti Narsai, Head of Scientific and Regulatory Affairs, Pharmaceutical Industry Association of South Africa

 

Raymonde de Vries, Corporate Quality Assurance, Unilever Foods

3:00-3:15 Break

SESSION FIVE
INTERNATIONAL AND DONOR ORGANIZATIONS ROUNDTABLE

Objective: To explore how international organizations are working on health systems and infrastructure building, and to understand the role of a strong regulatory framework for health, agriculture, and economic development.

3:15-4:30 Roundtable Discussion, Jim Riviere, Moderator
 

Gavin Steel, Senior Program Associate, Strengthening Pharmaceutical Systems, Management Sciences for Health

 

Celestine Kumire, Programme Manager, Southern African Regional Programme on Access to Medicines & Diagnostics, John Snow Inc.

 

Henry Leng, Senior Researcher, Accessing Medicines in Africa and South Asia

 

Nick Starke, Chairman, International Life Sciences Institute

 

Sarah Simons, Executive Director, Center for Agriculture and Bioscience International

4:40-4:50 Discussion Response
 

Sarah Olembo, Technical Expert SPS and Food Safety, African Union Commission

5:00 Adjourn
Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

FRIDAY, JUNE 24, 2011
ACADEMY OF SCIENCE OF SOUTH AFRICA

7:45-8:30 Working breakfast for committee members and staff at Illyria Hotel

image

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

MEETING 2—AGENDA
JULY 27-28, 2011

DAY ONE: WEDNESDAY, JULY 27, 2011
THE KECK BUILDING, ROOM 201

8:30 Breakfast available

SESSION 1—OPEN THE GLOBAL SYSTEM AND SUPPLY CHAIN

Objectives: To understand the depth and breadth of the publically available enforcement data, and the use of information technology for international surveillance, operations, and supply chain management.

9:00-9:15 Welcome and orientation
Jim Riviere, Committee Chair
9:20-9:50 Systems Mapping with EU and FDA Enforcement Data
  Ying Zhang, PhD Candidate, Georgetown University
Jake Chen, Committee Member
9:50-10:10 Questions
10:10-10:40 Global Information Technology Management
 

Noel Greis, Director, Kenan Institute of Private Enterprise, University of North Carolina at Chapel Hill

10:40-11:00 Questions
11:00-11:15 Break

SESSION 2—CLOSED
REPORT OUTLINE

Objective: To approve an outline for the final report, to assign sections.

SESSION 3—CLOSED
TRAVEL MEETING DEBRIEF

Objective: To review the themes that emerged in China, South Africa, and Brazil focusing on statement of task questions 1-5.

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

DAY TWO: THURSDAY, JULY 28, 2011
THE KECK BUILDING, ROOM 109

8:30 Breakfast available

SESSION 1—CLOSED
BIAS AND CONFLICT OF INTEREST REVIEW

Objective: To review bias and conflict-of-interest discussion.

SESSION 2—CLOSED
CORE ELEMENTS OF REGULATORY SYSTEMS

Objective: To draft recommendations on statement of task item A and questions 4, 5.

SESSION 3—CLOSED
BRIDGING THE GAPS IN REGULATORY SYSTEMS

Objective: To draft recommendations on statement of task item C and questions 6-9.

SESSION 4—OPEN
TELECONFERENCE WITH ANVISA

Objective: To learn about the Brazilian regulatory system

SESSION 5—CLOSED
A PLAN FOR THE FDA

Objective: To draft recommendations on statement of task items B, D, and F.

SESSION 6—CLOSED
PARTNERSHIPS

Ojective: To draft recommendations on statement of task item E and questions 10-13.

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

TRAVEL MEETING 3—AGENDA
AUGUST 31-SEPTEMBER 2, 2011

DAY ONE: WEDNESDAY, AUGUST 31, 2011
PUBLIC HEALTH FOUNDATION OF INDIA. VASANT KUNT. NEW DELHI

7:45-8:30 Working breakfast for committee members and staff at the Crowne Plaza Hotel

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Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

DAY TWO: THURSDAY, SEPTEMBER 1, 2011
TRAVELLING MEETINGS

7:15-8:00 Working breakfast for committee members and staff at the Crowne Plaza Hotel

image

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

DAY THREE: FRIDAY SEPTEMBER 2. 2011
TRAVELLING MEETINGS

7:15-8:00 Working breakfast for committee members and staff at the Crowne Plaza Hotel

image

Suggested Citation:"Appendix E: Meeting Agendas." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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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.

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