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Stronger Food and Drug Regulatory Systems Abroad (2020)

Chapter: Appendix B: Public Meeting Agendas

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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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Page 169
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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Page 170
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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Page 171
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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Page 172
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 173
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 174
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 175
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 176
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 177
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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Page 178

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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 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 PREPUBLICATION COPY: UNCORRECTED PROOFS B-1

B-2 STRONGER REGULATORY SYSTEMS ABROAD 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 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 9:00–9:30 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, 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 Delia Grace, Veterinary Epidemiologist, International Livestock Research Institute 1 Dr. Cormier was unable to attend due to the federal government shutdown. PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B B-3 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, PAHO 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 PREPUBLICATION COPY: UNCORRECTED PROOFS

B-4 STRONGER REGULATORY SYSTEMS ABROAD 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 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 PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B B-5 • 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 Biotheraputics 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 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 PREPUBLICATION COPY: UNCORRECTED PROOFS

B-6 STRONGER REGULATORY SYSTEMS ABROAD 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 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. PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B B-7 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 2:35-4:05 Panel Discussion with Session 6 Speakers Joshua Sharfstein, Moderator • What are the main challenges facing your agency with regards 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 2 Rescheduled from previous day. PREPUBLICATION COPY: UNCORRECTED PROOFS

B-8 STRONGER REGULATORY SYSTEMS ABROAD 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, 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 12:30–12:50 Driving Investment in the Regulatory Agency Javier Guzman, Technical Director, Pharmaceuticals and Health Technologies, Management Sciences for Health PREPUBLICATION COPY: UNCORRECTED PROOFS

APPENDIX B B-9 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 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 PREPUBLICATION COPY: UNCORRECTED PROOFS

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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