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 | |
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 | |
9:05–9:30 | 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 | |
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1 Dr. Cormier was unable to attend due to the federal government shutdown.
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 |
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 | |
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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 | |
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 | |
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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.
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 |
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2 Rescheduled from previous day.
2:35-4:05 | Panel Discussion with Session 6 Speakers |
Joshua Sharfstein, Moderator | |
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4:05 | Adjourn Public Meeting |
SESSION 6—CLOSED
COMMITTEE DEBRIEF
4:05–5:00 | Committee Debrief |
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 |
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 | |
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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 | |
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5:00 | Adjourn |