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Stronger Food and Drug Regulatory Systems Abroad (2020)

Chapter: Appendix B: Public Meeting Agendas

« Previous: Appendix A: Committee Member Biographies
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
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Appendix B

Public Meeting Agendas

COMMITTEE ON STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD

The Keck Center, 500 Fifth Street, NW
Washington, DC 20001

JANUARY 8, 2019
ROOM 100

8:30 Breakfast available

SESSION 1—CLOSED
BIAS AND CONFLICT OF INTEREST
OVERVIEW OF STUDY

9:00–12:00 Bias and Conflict of Interest Discussion Overview of National Academies’ Processes Review Study Statement of Task and Timeline
12:00–1:00 Lunch
1:00–1:30 Overview of Report Communications
1:30–1:45 Break
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

SESSION 2—OPEN
CAPACITY AND INSTITUTIONAL DEVELOPMENT

1:45–2:15 The Global Benchmarking Tool
Mike Ward, Coordinator, Regulatory Systems Strengthening, Essential Medicines and Health Technologies, World Health Organization
2:15–2:45 Institutional Development and Financing
Analia Porrás, Unit Chief, Medicines and Health Technologies, Health Systems and Services, Pan American Health Organization
2:45–4:30 Panel Discussion on Management of the Regulatory Agency
Mikel Arriola, Committee Member, Moderator
Lembit Rago, Secretary General, Council for International Organizations of Medical Sciences
Kenneth Hartigan-Go, Associate Professor, Department of Strategic Management & Head
Stephen Zuellig, Graduate School of Development Management, Asian Institute of Management
Dali Yang, William C. Reavis Professor of Political Science & Senior Advisor to the President and the Provost on Global Initiatives, University of Chicago
4:30 Adjourn
6:00 Working dinner for committee and staff at Rasika restaurant
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

JANUARY 9, 2019
ROOM 100

8:30 Breakfast available in Room 105

SESSION 3—OPEN
CAPACITY CONTINUED,
TECHNICAL ASSISTANCE AND LOCAL MARKETS

9:00 Welcome
Catherine Woteki, Committee Chair
9:05–9:30 Benchmarking for Food Safety
Steven Jaffee, Lead Rural Development Specialist, World Bank (by phone)
9:30–10:00 Technical Assistance and Accountability
Renata Clarke, Senior Food Safety and Quality Officer, Food Safety and Quality Unit, Food and Agriculture Organization (FAO) (by video)
10:00–10:15 Break
10:15–11:45 Panel Discussion on Donor and Private-Sector Engagement
Jono Quick, Committee Member, Moderator
Kelley Cormier, Division Chief, Bureau for Food Security, U.S. Agency for International Development1
Nuri Gras, Executive Secretary, Chilean Food Safety and Quality Authority
Dilip Shah, Secretary General, Indian Pharmaceutical Alliance (by video)
Jude Nwokike, Director, Promoting the Quality of Medicines, U.S. Pharmacopeia
11:45–12:45 Lunch for committee, speakers, and staff in Room 105
12:45–2:15 Panel Discussion on Product Quality and Local Markets
Joshua Sharfstein, Committee Member, Moderator

___________________

1 Dr. Cormier was unable to attend due to the federal government shutdown.

Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Delia Grace, Veterinary Epidemiologist, International Livestock Research Institute
Spencer Henson, Professor, University of Guelph
Elizabeth Pisani, Associate Professor, School of Health Policy and Management, Erasmus University
Gugu Mahlangu, Director General, Medicines Control Authority of Zimbabwe
2:15–2:30 Break

SESSION 5—OPEN
HARMONIZATION AND REGIONAL COOPERATION

2:30–4:00 Panel Discussion on Regional Cooperation
Prashant Yadav, Committee Member, Moderator
Lisa Indar, Program Manager, Tourism and Health, Caribbean Public Health Agency
Jarbas Barbosa, Assistant Director, Pan American Health Organization
Larry Liberti, Executive Director, Centre for Innovation in Regulatory Science
Gugu Mahlangu, Director General, Medicines Control Authority of Zimbabwe
Anban Pillay, Deputy Director General for Health Regulation and Compliance, National Department of Health (by phone)

SESSION 6—CLOSED
COMMITTEE DELIBERATIONS

4:00–5:00 Committee Deliberations
5:00 Adjourn
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Committee on Stronger Food and Drug Regulatory Systems Abroad

Academy of Sciences of Costa Rica
Los Yoses, San Pedro, Costa Rica

FEBRUARY 25, 2019

9:00–9:15 Welcome and Introductions
Catherine Woteki, Committee Chair
9:15–9:30 Opening Remarks
Pedro Leon, Academy of Sciences of Costa Rica
9:30–9:45 Introduction to Food and Drug Administration Latin America
Katherine Serrano, Director, Latin America Office, Food and Drug Administration
9:45–10:00 Break

SESSION 1—OPEN
FOOD SAFETY SYSTEMS

10:00–10:25 Food and Agriculture Organization and World Health Organization Food Control Assessment Tool
Marisa Caipo, Food Safety and Quality Officer, FAO Regional Office for Latin America and the Caribbean
10:25–10:50 New Food Safety Management System for Ecuador
Rommel Anibal Betancourt Herrera, General Coordinator of Food Safety, Agency for Regulation and Control of Plant and Animal Health (AGROCALIDAD)
10:50–11:15 The Effects of the U.S. Food Safety Modernization Act on Local Markets
Ana Marisa Cordero, Specialist, Agricultural Health and Food Safety, Inter-American Institute for Cooperation on Agriculture
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
11:15–11:40 The Effect of Codex Standards on Local Food Markets
Tatiana Cruz Ramirez, Head, Department of Technical Regulation and Codex, Ministry of Economy, Industry and Commerce, Costa Rica
11:40–12:40 Lunch
12:40–2:20 Panel Discussion on Food Safety (All Session 1 Speakers)
Mikel Arriola, Moderator
  • Latin American countries generally have large agricultural sectors that employ a lot of people. Do you see a tension between food regulation for the promotion of trade and food regulation for domestic consumption?
  • Most food safety systems emphasize choosing priorities based on risk. What are the barriers to doing this?
  • What factors aid or hold back your ability to work with other countries in the region on foodborne disease, outbreaks, and emergencies? How would you say this has changed over the last 5 to 10 years?
2:20–2:35 Break

SESSION 3—OPEN
MEDICAL PRODUCT SAFETY SYSTEMS

2:35–3:05 Strengthening Medicines Regulation in Central America
Jose Vicente Coto Ugarte, Regional Consultant, Medicines, Pan American Health Organization
3:05–3:35 Approval and Registration of Biotherapeutics
Emilio Medina, Technical and Scientific Director, Development and Research Processes, National Polytechnical Institute of Mexico
Mayra Perez-Tapia, Executive Director & Research Professor, Unit for Development and Research in Bioprocesses, National Polytechnical Institute of Mexico
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
3:35–4:05 Licensing and Inspection of Drug Manufacturer, Import, and Wholesale
Jean Carlo Apuy, Enforcement, College of Pharmacy of Costa Rica (COLFAR)
4:15 Adjourn

FEBRUARY 26, 2019

9:00–9:15 Welcome
Catherine Woteki, Committee Chair

SESSION 4—OPEN
INDUSTRY AND CONSUMER PERSPECTIVES

9:15–11:00 Panel Discussion on Openness and Industry’s Role in Regulatory Systems
Maria Elena Bottazzi, Moderator
  • How would you describe the relationship between public confidence in your products and the strength of the regulatory agency?
  • How do you see industry’s role in building strong regulatory agencies in the countries where you work?
  • Can you share examples of times when you found regulatory action to be predictable and objective and times when it was not?
  • What is your experience of the regulatory agencies’ ability to respond to new technologies?
Rivelino Flores, Director of Regulatory Affairs and Innovation, National Chamber of the Pharmaceutical Industry
Monique Collaço de Moraes Stávale, Vice Director of Quality, Bio-Manguinhos, Oswaldo Cruz Foundation
Paula Vargas, Regulatory Leader, Pfizer, Central America and the Caribbean
Lissy Cruz, Regulatory Manager, Fedefarma
Mario Montero, Executive Vice President, Cámara Costarricense de la Industria Alimentaria, the food industry association of Costa Rica
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
11:00–11:15 Break
11:15–11:45 Open Sharing of Government Data
Ana Gabriel Zuniga, Hivos Latin America
11:45–12:15 Information, Education, and Communication with Consumers
Carolina Paz, Center for Consumer Defense, El Salvador
12:15–1:15 Lunch

SESSION 5—OPEN
THE CHALLENGES FACING REGULATORY AGENCIES

In their brief introductory comments, speakers are asked to describe their agency, its responsibilities, when it was founded, and how it is funded.

1:15–1:40 Staff and Agency Development Planning2
Maria Angelica Sanchez Herrera, former Head, Office of International Affairs, National Institute for Drug and Food Surveillance (Invima)
1:40–1:55 Introduction to ARSA
Iris Galeano, Commissioner, Sanitary Regulatory Agency (ARSA) Honduras
1:55–2:10 Introduction to ARCSA
Juan Carlos Galarza, Executive Director, National Agency for Health Regulation, Control, and Surveillance (ARCSA), Ecuador
2:10–2:25 Introduction to Anvisa
Dirceu Barbano, former Director General, National Health Surveillance Agency (Anvisa) Brazil
2:25–2:35 Break

___________________

2 Rescheduled from previous day.

Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
2:35-4:05 Panel Discussion with Session 6 Speakers
Joshua Sharfstein, Moderator
  • What are the main challenges facing your agency with regard to food safety, medicine, and vaccine safety?
  • Would you say staff retention is a problem, and if so, what do you think would help retain talented workers?
  • Is the food and drug regulatory agency a priority for heads of government, ministers of health, and ministers of finance? If not, what might persuade them to make it one?
  • What are the main barriers to persuading heads of government to invest in regulatory systems?
4:05 Adjourn Public Meeting

SESSION 6—CLOSED
COMMITTEE DEBRIEF

4:05–5:00 Committee Debrief
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Committee on Stronger Food and Drug Regulatory Systems Abroad

National Academy of Sciences,
2101 Constitution Avenue, NW, Washington, DC 20418

APRIL 3, 2019
ROOM 125

SESSION 1—OPEN
BUILDING SYSTEMS ON RISK

9:00–9:15 Welcome and Introductions
Catherine Woteki, Committee Chair
9:15–9:45 Reforms at FSSAI
Pawan Agarwal, Chief Executive, Food Safety and Standards Authority of India (by video)
9:45–10:15 Risk Based Food Safety in Ethiopia
Barbara Kowalcyk, Assistant Professor, Food Science and Technology, The Ohio State University
10:15–10:30 Break

SESSION 2—OPEN
RAISING THE PROMINENCE OF REGULATORY SYSTEMS

10:30–10:50 Regulatory Systems and Public Health
Carlos Santos Burgoa, Professor, Department of Global Health, The George Washington University
10:50–11:10 The Hidden Costs of Neglecting Medicines Regulation
Mac Lumpkin, Deputy Director Integrated Development, Bill & Melinda Gates Foundation (by video)
11:10–11:30 Industry Action to Improve Regulatory Systems
Uy Hong Nguyen, Regulatory and External Affairs Director, Abbott Nutrition, Vietnam
11:30–12:30 Lunch in cafeteria
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
12:30–12:50 Driving Investment in the Regulatory Agency
Javier Guzman, Technical Director, Pharmaceuticals and Health Technologies, Management Sciences for Health
12:50–2:15 Panel Discussion: All Morning Speakers
Catherine Woteki, Moderator
  • What messages would best encourage investment in regulatory systems? How would the messages differ for donors, ministers of health, and ministers of finance?
  • Can you describe the communication strategy that regulatory agencies could use to improve understanding of their work by the public and a strategy to better advocate for support from their ministers?
2:15–2:30 Break

SESSION 3—OPEN
DONOR MOTIVATORS AND THE FUTURE OF AID

2:30–2:50 Gavi Transition Financing
Santiago Cornejo, Senior Specialist, Immunization Financing, Gavi
2:50–3:10 Facilitating Safer Food Systems
Kelley Cormier, Division Chief, Inclusive Market Development, U.S. Agency for International Development
3:10–3:30 U.S. Agency for International Development Support for Drug Regulatory Systems: Reasons for Involvement and Changes Over Time
Lisa Ludeman, Senior Pharmaceutical Management Technical Advisor, U.S. Agency for International Development
3:30–3:50 Managing Risk and Benefits in Medicines Systems: The Example of Dolutegravir
Alain Prat, Team Lead, Quality Assurance, The Global Fund
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
3:50–5:00 Panel Discussion: Session 3 Speakers
Julie Caswell, Moderator
  • Would you agree that food and drug regulatory systems have not been a donor priority in the past? Could you explain why that might be or what might change it?
  • How do you expect the substance and manner of donor involvement in health to change over the next 10 years?
5:00 Adjourn
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 203
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 204
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 205
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 206
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 207
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 208
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 209
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 210
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 211
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 212
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 213
Suggested Citation:"Appendix B: Public Meeting Agendas." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page 214
Next: Appendix C: Call for Comments »
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Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone.

The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress.

The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

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