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PAPERBACK price:$64.00 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources PDF SUMMARY Display this book on your site! Related Titles Enhancing Food Safety:The Role of the Food and Drug Administration Ensuring Safe Food:From Production to Consumption Other Related Titles Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) Board on Global Health (BGH) Board on Health Sciences Policy (HSP) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "Appendix E: Meeting Agendas." Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press, 2012. Please select a format: Page 297   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore Page 297 Front Matter (R1-R18) Summary (1-12) 1 Introduction (13-32) 2 Core Elements of Regulatory Systems (33-78) 3 Critical Issues (79-146) 4 A Strategy to Building Food and Medical Product Regulatory Systems (147-164) 5 International Action (165-192) 6 Domestic Action (193-234) 7 Conclusions and Priorities (235-242) Appendix A: Glossary (243-252) Appendix B: A Review of Tort Liability's Role in Food and Medical Product Regulation (253-272) Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China (273-282) Appendix D: Chinese Food Regulatory System (283-296) Appendix E: Meeting Agendas (297-318) Appendix F: Committee Member Biographies (319-328) Appendix G: Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed (329-344) Appendix H: Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration (345-348)

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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 com- mittee in addressing the statement of task; and to ensure the committee understands its statement of task. 297

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298 ENSURING SAFE FOODS AND MEDICAL PRODUCTS 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 Questions 1:05-1:25 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

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299 APPENDIX E 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

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300 ENSURING SAFE FOODS AND MEDICAL PRODUCTS DAY TWO: THURSDAY, MARCH 3, 2011 KECK BUILDING, ROOM 110 Day 2 Goals: 1. Learn about existing recommendations and the obstacles to imple- menting 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

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301 APPENDIX E 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 recommenda- tions, and give feedback on the meeting.

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302 ENSURING SAFE FOODS AND MEDICAL PRODUCTS 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

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303 APPENDIX E 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. Panel Discussion, Martha Brumfield, Moderator 1:00-2:30 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. Panel discussion, Jake Chen, Moderator 3:00-4:30 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

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DAY DAY TWO: THURSDAY, MAY 12, 2011 TWO: THURSDAY, MAY 12, 2011 304 CHINESE ACADEMY OF ENGINEERING, BEIJING CHINESE ACADEMY OF ENGINEERING,BEIJING 7:30-8:15 7:30-8:15 Working breakfast forfor committee and staff atat Intercontinental Hotel Working breakfast committee and staff Intercontinental Hotel 8:30 9:00 9:30 10:00 10:30 11:00 11:30 12:00 12:30 1:00 1:30 2:00 2:30 3:00 3:30 4:00 4:30 5:00 5:30 SFDA at Rx at CAE GIZ at GIZ SFSDA Martha Martha Brumfield Martha Brumfield Brumfield Jake Chen Jake Chen Jake Chen Travel Lunch Travel Patrick Kelley Kelley, Ginivan Kelley, Ginivan Note taking Note taking Note taking Steve Yang, AZ Chris Hickey Translator Wen Chang, BMS Food Cos at CAE Corrie Brown Meg Ginivan Travel Qiang Zheng Note taking Note taking Note taking Penggui Zhai Translator Travel Lunch Travel Travel Note taking Note taking Note taking AQSIQ at AQSIQ WHO at WHO FDA at Intercon

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305 APPENDIX E 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 Panel Discussion, Jake Chen, Moderator 9:00-10:00 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 Closing remarks, Thanh Nguyen, Regional Quality Director 1:00-2:00 Asia-Pacific Supply Chain, Wrigley

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306 ENSURING SAFE FOODS AND MEDICAL PRODUCTS SESSION THREE THE FDA PERSPECTIVE CHINA HOTEL, GUANGZHOU Panel Discussion, Corrie Brown, Moderator 3:30-5:00 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 SÃO PAULO, SCHOOL OF PUBLIC HEALTH, PROFESSOR EDMUNDO JUAREZ ROOM AVENIDA DOUTOR ARNALDO, 715, SÃO 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 São 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

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307 APPENDIX E 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 São 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 incen- tives could help them comply with standards and harmonization efforts. Roundtable Discussion, Clare Narrod, Moderator 1:40-2:45 Rosane Cuber Guimarães, Good Practices Manager, Department of Quality Assurance, Bio-Manguinhos/ Fiocruz

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308 ENSURING SAFE FOODS AND MEDICAL PRODUCTS 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 Débora Germano, Associate Director of Regulatory Affairs, Pfizer Brazil 2:45-3:05 Discussion Response Silvia Storpirtis, Associate Professor, University of São Paulo School of Pharmaceutical Sciences Marco Antonio Stephano, Professor, University of São 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. Roundtable Discussion, Tom Bollyky, Moderator 3:20-4:30 Raymond Dugas, Regional Food Safety Advisor, PAHO Sergio Nishioka, Scientist, WHO, Department of Immunization, Vaccines and Biologicals Ana Marisa Cordero Peña, 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

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DAY TWO: TUESDAY, JUNE 21, 2011 DAY TWO: TUESDAY JUNE 21. 2011 NI V UNIVERSITYUOF ERSITY PAULO, ULO, SCHOOOFFPBULIC EHEALTH—SÃO BRAZIL BRAZIL SÃO OF SÃO PA CHOOL L O PUBLIC H ALTH - SÃO PAULO, PAULO 7:30-8:15 7:45-8:30 Working breakfastfor committee membersstaffstaffthe Sofitel Working breakfast for committee and and at at the Sofitel 9:00 9:30 10:00 10:30 11:00 11:30 12:00 12:30 1:00 1:30 2:00 2:30 3:00 3:30 4:00 4:30 5:00 Medical Devices Medical Devices Food Jim Riviere Jim Riviere Jim Riviere Jim Riviere Jim Riviere Jim Riviere Tom Bollyky Tom Bollyky Tom Bollyky Tom Bollyky Tom Bollyky Tom Bollyky Villar Goulart GGillian Buckley illian Pereira Stephano V(No translator) illar PFranco Poldi ereira Buckley Spindel Note taking Note taking (Portuguese Goulart P(Portuguese translator) oldi, Franco Stephano, Spindel translator) Prof. Y. R.Gandra Room FDA FDA Vaccine Food Ag Carlos Morel Carlos Morel Carlos Morel Carlos Morel Carlos Morel Carlos Morel Clare Narrod lare Narrod Clare Narrod Clare Narrod CClare Narrod Clare Narrod Andy Kenisha Peters KKenisha Peters enisha Peters Kenisha Peters Andy Stergachis Flight to South Africa Stergachis Lunch Nishioka Cuber Cordero Pena Kenisha Peters Nishioka Cordero Pena Kenisha Peters @ 6 p.m. Note taking Note taking Note taking Guimares Taniwaki Dugas Osario Cuber (Portuguese (No translator) (No translator) Prof. J.M. de Barros Room Guimares Osario translator) Drugs ARegulators ndy Andy Stergachis Andy Stergachis Stergachis Andy Stergachis Gillian Buckley Gillian Buckley Gillian Buckley Gillian Buckley Ramilo Poblete Pinto Rebelo Poblete into Lazaneo P(Portuguese Note taking Note taking Lazaneo, translator) (Spanish translator) Prof. Edm. Juarez Room Ramilo Rebelo 309

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310 ENSURING SAFE FOODS AND MEDICAL PRODUCTS 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 partici- pants 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.

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311 APPENDIX E Roundtable Discussion, Andy Stergachis, Moderator 9:55-11:10 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 incen- tives could help them comply with standards and harmonization efforts. Roundtable Discussion, Tom Bollyky, Moderator 1:45-3:00 Elaine Alexander, Executive Director, South Africa Table Grape Industry Maeve Magner, Chief Executive, RTT

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312 ENSURING SAFE FOODS AND MEDICAL PRODUCTS 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. Roundtable Discussion, Jim Riviere, Moderator 3:15-4:30 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

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FRIDAY,JUNE 24, 2011 FRIDAY, JUNE 24, 2011 ACADEMY OF SCIENCE OF SOUTH AFRICA ACADEMY OF SCIENCE OF SOUTH AFRICA 7:45-8:30 7:45-8:30 Working breakfast for committee committee members Illyria Hotel Illyria Hotel Working breakfast for members and staff at and staff at 9:00 9:30 10:00 10:30 11:00 11:30 12:00 12:30 1:00 1:30 2:00 2:30 3:00 3:30 Biol. Regulators Food Regulators Jim Riviere Jim Riviere Clare Narrod Clare Narrod Kenisha Peters Kenisha Peters Note taking Note taking Crookes, Bird Olembo Litthauer, Pepper Wigenge Med. Regulators Health System Andy Stergachis Andy Stergachis Closed Meeting Gillian Buckley Gillian Buckley Lunch Illyria Hotel Yoongthong Leng Note taking Note taking Next Steps Crisp Banoo Ndomomdo-Sigonda Steel, Kumire Medical Products Food Industry Tom Bollyky Tom Bollyky Patricia Cuff Patricia Cuff Ngozwana de Vries Note taking Note taking Narsai Magner Vogt 313

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314 ENSURING SAFE FOODS AND MEDICAL PRODUCTS 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.

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315 APPENDIX E 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 Dirceu Barbano, Director, ANVISA (teleconference) 1:00-2:00 Carlos Morel, Discussion Leader 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 Objective: To draft recommendations on statement of task item E and questions 10-13.

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TRAVEL MEETING ING 3 - AGENDA TRAVEL MEET 3—AGENDA 316 AUGUST 31-SEPTEMBER 2,2, 2011 August 31-September 2011 DAY ONE:ONE: WEDNESDAY, AUGUST 31, 2011 DAY WEDNESDAY, AUGUST 31, 2011 PUBLIC HEALTH FOUNDATION OF INDIA, VASANT KUNJ, NEW DELHI PUBLIC HEALTH FOUNDATION OF INDIA, VASANT KUNJ, NEW DELHI 7:45-8:30 7:45-8:30 Working breakfast for for committee members and the Crowne Plaza HotelPlaza Hotel Working breakfast committee members and staff at staff at the Crowne 9:00 9:30 10:00 10:30 11:00 11:30 12:00 12:30 1:00 1:30 2:00 2:30 3:00 3:30 4:00 4:30 5:00 International Orgs. Pharmaceuticals Vaccines Medical Products Jim Riviere Jim Riviere Jim Riviere Jim Riviere Bob Buchanan Bob Buchanan Bob Buchanan Bob Buchanan Gillian Buckley Gillian Buckley Gillian Buckley Gillian Buckley Lunch Kenisha Peters Kenisha Peters Kenisha Peters Kenisha Peters Bejon Misra Dilip Shah Sunil Bahl Jagdish Dore Note taking Note taking Abhay Kadam Pramod Kumar Ajay Pitre Jasvir Singh

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DAY AY TWO: THURSDAY, SEPTEMBER 1, 2011 D TWO: THURSDAY, SEPTEMBER 1, 2011 TRAVELLING MEETINGS TRAVELLING MEETINGS 7:15-8:00 7:15-8:00 Working breakfast for committee membersmembers and staff at theHotel Working breakfast for committee and staff at the Crowne Plaza Crowne Plaza Hotel 8:30 9:00 9:30 10:00 10:30 11:00 11:30 12:00 12:30 1:00 1:30 2:00 2:30 3:00 3:30 4:00 4:30 5:00 Export Council Pharma @ PHFI Working Lunch @ APEDA @ APEDA Kenisha Peters @ Export Council Kenisha Peters Quality Council Kenisha Peters Prashant Yadav Bob Buchanan Gillian Buckley Kenisha Peters Prashant Yaday Gillian Buckley Bob Buchanan Prashant Jim Riviere BBob Buchanan ob Buchanan SS.Dave . Dave Jim Riviere Yadav Neeraj Mohan Kenisha Peters Asit Tripathy Neeraj Mohan Asit Tripathy Kenisha Peters Bob Buchanan Anil Pareek Prashant Yadav Devendra Prasad Devendra Prasad Prashant Yadav S.K. Saxena Sana Mostaghim Bob Buchanan Rajeev Note taking Anil Jauhri Anil Pareek Bob Buchanan Raizada Vani Bhambri Arora Travel to APEDA Sana Mostaghim Anil Jauhri R.M. Mandlik Travel to Export Council Travel to Quality Council C.B. Kotak Vani Bhambri Arora Arvind Patil Pramod Swaich Chamber of Indian Pharmacopeia Commerce @ FCCI @ FICCI @ PHFI Jim Riviere Jim Riviere Jim Riviere Jim Riviere Gillian Gillian Buckley Gillian Buckley Council Sameer GG. N. Buckley illian Singh Buckley Barde Note taking G.N. Singh Sameer Barde Travel to FICCI Travel to Quality 317

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DAY THREE: FRIDAY SEPTEMBER 2. 2011 DAY THREE: FRIDAY SEPTEMBER 2. 2011 318 TRAVELLING MEETINGS TRAVELLING MEETINGS 7:15-8:00Working breakfast for committee members and staff at the Crowne Plaza Plaza Hotel 7:15-8:00 Working breakfast for committee members and staff at the Crowne Hotel PATH @ PATH Min. of Chem. @ Regulators @ Jim Riviere JAYUSH @ AYUSH im Riviere PHFI BHEL Jim Riviere Jim Riviere Kenisha Peters Jim Riviere Kenisha Peters Kenisha Peters Kenisha Peters Prashant Yadav Kenisha Peters Prashant Yadav Prashant Yadav Prashant Yadav Gillian Buckley Prashant Yadav Ghazala Javed Ghazala Javed Lunch Gillian Buckley Bob Buchanan Arun Jha JJanardhanPandey anardhan Pandey Note taking Note taking Bob Buchanan Tarun Vij + staff D.C.Mitra M. Katoch Travel to PATH Travel to AYUSH W. Yoongthong Moazzem Hossain USAID @ Embassy FDA @ Embassy USDA @ Embassy Gillian Buckley Gillian Buckley Gillian Buckley Gillian Buckley Bob Buchanan Bob Buchanan Bob Buchanan Bob Buchanan David Leishman Bruce Ross James Browder Lunch David Leishman Ritambhara Singh