Stronger Food and Drug Regulatory Systems Abroad (2020) / Chapter Skim
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Appendix B: Public Meeting Agendas
Appendix B: Public Meeting Agendas
Pages 203-214
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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 203
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204 STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD 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
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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.
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206 STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD 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
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Food Safety Modernization Act on Local Markets Ana Marisa Cordero, Specialist, Agricultural Health and Food Safety, Inter-American Institute for Cooperation on Agriculture
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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
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• 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
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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)
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• 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
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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
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• 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.
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• How do you expect the substance and manner of donor involvement in health to change over the next 10 years? 5:00 Adjourn
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