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Appendix E: Meeting Agendas
Pages 297-318

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From page 297... ... 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 committee in addressing the statement of task; and to ensure the committee understands its statement of task. Read the entire page →
From page 298... ... 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 Read the entire page →
From page 299... ... 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 Read the entire page →
From page 300... ... 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 Read the entire page →
From page 301... ... 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 recommendations, and give feedback on the meeting. Read the entire page →
From page 302... ... 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 Read the entire page →
From page 303... ... 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 Read the entire page →
From page 304... ... 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 Read the entire page →
From page 305... ... 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 Read the entire page →
From page 306... ... 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. Read the entire page →
From page 307... ... 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 incentives could help them comply with standards and harmonization efforts. Read the entire page →
From page 308... ... 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 Read the entire page →
From page 309... ... 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. Read the entire page →
From page 310... ... FDA 9:45-9:55 Questions SESSION THREE REGULATORS' ROUNDTABLE Objective: To understand how African regulators work and the key issues they face. Read the entire page →
From page 311... ... Roundtable Discussion, Tom Bollyky, Moderator 1:45-3:00 Elaine Alexander, Executive Director, South Africa Table Grape Industry Maeve Magner, Chief Executive, RTT Read the entire page →
From page 312... ... 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 Read the entire page →
From page 313... ... 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 Read the entire page →
From page 314... ... 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. Read the entire page →
From page 315... ... 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. Read the entire page →
From page 316... ... 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 Read the entire page →
From page 317... ... 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. Read the entire page →
From page 318... ... 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 Read the entire page →

From page 297...

... 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 committee in addressing the statement of task; and to ensure the committee understands its statement of task.

Appendix E: Meeting Agendas Pages 297-318

Appendix E: Meeting Agendas
Pages 297-318