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Appendix C: Meeting Agendas
Pages 339-352

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From page 339... ... Appendix C Meeting Agendas March 12-13, 2012 Meeting 1 -- Agenda Washington, DC DAY ONE: MONDAY, MARCH 12, 2012 Session 1 – Closed IOM Committee Process and Charge to Committee Room 204 Objective: 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. Session 2 – Open Questions on Statement of Task Room 100 11:10-11:30 Project Timeline and Statement of Task Sponsor Representative Introductions Larry Gostin, Committee Chair 11:30-11:45 The Charge to the Committee Jennifer Devine, Deputy Director, Global Regulatory Operations & Policy, FDA Kate Bond, Associate Director for Technical Cooperation and Capacity Building, FDA 11:45-12:15 Questions 339 Read the entire page →
From page 340... ... 340 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS 12:15-1:15 Lunch Session 3 – Open Technologies for Detecting Unsafe Drugs Room 100 1:15-1:25 Welcome and Introductions Larry Gostin, Committee Chair 1:25-1:45 The Strengths and Weaknesses of the Detection Technologies Currently Available Mark Witkowski, Supervisory Chemist, Trace Examination Section, Forensic Chemistry Center, FDA 1:50-2:10 Importance of Reliable Detection Technologies in the Field Ashifi Gogo, Chief Executive, Sproxil 2:15-2:30 Break 2:30-2:50 Using Analytic Detection Technologies in Singapore Lim Chin Chin, Forensic Laboratory Director and Forensic Scientist, Singapore Health Science Authority 2:55-3:15 Using Analytic Detection Technologies in Peru Percy Alberto Ocampo Rujel, former Executive Director, Directorate of Control and Health Surveillance, Peru 3:20-3:40 Case Study on Merck's Use of Detection Technologies Anthony Zook, Director of Anti-Counterfeiting, Merck 3:45-4:30 Panel Discussion, The Future of Reliable Detection Technologies in the Field Patrick Lukulay, Moderator Session 4 – Closed Committee Planning Read the entire page →
From page 341... ... APPENDIX C 341 DAY TWO: TUESDAY, MARCH 13, 2012 ROOM 100 Session 5 – Open Framing and Defining the Problem 8:15-8:30 Opening Remarks Mary Lou Valdez, Associate Commissioner, Office of International Programs, FDA 8:45-9:45 Varying Interpretations of the Terms Counterfeit, Falsified, and Substandard Howard Zucker, Senior Advisor, Massachusetts General Hospital Rohit Malpani, Senior Advisor for Campaigns, Oxfam America Roger Bate, Legatum Fellow in Global Prosperity, American Enterprise Institute David R Gaugh, Vice-President for Regulatory Science, Generic Pharmaceutical Association 9:45-10:15 Panel Discussion on Terminology and the Problem of Fake Drugs Bryan Liang, Moderator 10:15-10:30 Break 10:30-11:45 Economic and Trade Interests in Counterfeit, Falsified, and Substandard Drugs Nicholas Cappuccino, Chief Executive, Pharmaceutical Intellectual Resource Services, LLC John Clark, Chief Security Officer and Vice President of Global Security, Pfizer Jamie Love, Director, Knowledge Ecology International 11:45-12:15 Panel Discussion on Health, Economic, and Trade Dimensions of the Problem Moderator Prashant Yadav, 12:15-1:15 Lunch Read the entire page →
From page 342... ... Department of Justice Jeffery Gren, Director, Office of Health and Consumer Goods, U.S. Department of Commerce Ilisa Bernstein, Director, Office of Compliance, Center for Drug Evaluation Research, FDA Margareth Ndomondo-Sigonda, Moderator 3:30-3:45 Break Session 7 – Open Scope of Work on the Problem 3:45-4:30 Investigating Trends and Analyzing Policy in Pharmaceutical Fraud Laurie Garrett, Senior Fellow for Global Health, Council on Foreign Relations Alan Coukell, Director Medical Programs, Pew Health Group Judit Rius, U.S. Read the entire page →
From page 343... ... DAY TWO: THURSDAY, MAY 10, 2012 ROOM 206 Session 5 – Open FDA Data on Fake Drugs 10:30-11:30 The FDA's estimates of the scope of the problem Jen Devine, Regulatory Counsel, CDER Office of Compliance 11:30-12:00 Questions June 26-July 4, 2012 Travel Meeting -- Agenda Geneva, London, New Delhi, Hyderabad DAY ONE: TUESDAY, JUNE 26, 2012 GENEVA, SWITZERLAND 3:15-3:30 Travel to Global Fund 3:30-5:00 Meeting at Global Fund Joelle Daviaud, Quality Assurance Specialist and Grant Management Support, the Global Fund to Fight AIDS, Tuberculosis, and Malaria Read the entire page →
From page 344... ... 344 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Mariatou Tala Jallow, Manager, Procurement Support Service, the Global Fund to Fight AIDS, Tuberculosis, and Malaria DAY TWO: WEDNESDAY, JUNE 27, 2012 GENEVA, SWITZERLAND 9:15-10:00 Working breakfast for committee members and staff at Movenpick Hotel 10:30-11:30 Amir Attaran, Associate Professor, Faculties of Law and Medicine, University of Ottawa 12:30-1:45 Lunch 1:45-2:00 Travel to South Centre 2:00-3:30 Meeting at South Centre German Velasquez, Senior Advisor of Health and Development, South Centre Nirmalya Syam, Program Officer, Innovation and Access to Knowledge Program, South Centre 3:30-4:00 Travel to NGO Forum for Health 4:00-5:00 Meeting with NGO Forum for Health Alan Leather, President, NGO Forum for Health DAY THREE: THURSDAY, JUNE 28, 2012 GENEVA, SWITZERLAND 8:30-9:15 Working breakfast for committee members and staff at Movenpick Hotel 9:15-9:30 Travel to WHO 9:30-11:00 Meeting at WHO with Interpol Aline Plançon, Enforcement Officer, Interpol Naill Sargent, Criminal Intelligence Analyst, Interpol 11:45-12:00 Travel to Third World Network Read the entire page →
From page 345... ... APPENDIX C 345 12:00-1:30 Meeting at Third World Network Sangeeta Shashikant, Legal Advisor, Third World Network 1:30-2:15 Lunch 2:15-2:30 Travel to WHO 2:30-5:00 Meeting at WHO Kees de Joncheere, Regional Adviser, Health Technology and Pharmaceuticals, WHO Sabine Kopp, Manager, Medicines Quality Assurance Program, WHO Michele Forzley, Professor, Widener School of Law and Georgetown School of Law DAY FOUR: FRIDAY, JUNE 29, 2012 LONDON, ENGLAND 8:30-9:45 Working breakfast for committee members and staff at Thistle Grosvenor Hotel 9:45 Travel to EMA 10:30-12:00 Meeting at EMA Emer Cooke, Acting Head, International and European Cooperation, EMA 12:00-1:30 Lunch 1:30-2:00 Travel to Chatham House 2:00-5:00 Meeting at Chatham House Charles Clift, Senior Research Consultant, Centre on Global Health Security, Chatham House Paul Newton, Director, Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration Harparkash Kaur, Professor, London School of Hygiene and Tropical Medicine Sharon Peacock, Professor, University of Cambridge Simeon Wilson, Director, Global Security, AstraZeneca Read the entire page →
From page 346... ... 346 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Paul Ellis, Director, External Advocacy, GlaxoSmithKline Mohga Kamal-Yanni, Senior Health and HIV Policy Adviser, Acting Team Lead Development Finance and Public Service, Oxfam Philippa Saunders, Consultant Wendy Greenall, Counterfeit Medicines Laboratory Manager, Pfizer Greg Perry, Director General, European Generic Medicines Association Francis Roodt, Intellectual Property Office Lynda Scammell, Senior Policy Manager and Relationship Manager, Enforcement Group, Medicines and Healthcare Products Regulatory Agency DAY FIVE: MONDAY, JULY 2, 2012 NEW DELHI, INDIA 7:00-7:45 Working breakfast for committee members and staff at Crowne Plaza Hotel 7:45 Travel to PATH 8:30-10:00 Meeting at PATH Raj Shankar Ghosh, Technical Director, PATH Sonali Kochhar, Medical Director, PATH Pritu Dhalaria, Director, Immunization Projects, PATH Satish Kaipilyawar, Project Director, TB Program, PATH 10:00-11:00 Travel to Ministry of Health and Family Welfare 11:00-12:30 Meeting at Ministry of Health and Family Welfare L.C. Goyal, Additional Secretary and Director General, Central Government Scheme, Ministry of Health and Family Welfare Arun Panda, Joint Secretary, Ministry of Health and Family Welfare 12:30-1:30 Lunch Read the entire page →
From page 347... ... FDA Bruce Ross, Director, India Office, FDA Regina Brown, Assistant Director of Medicines, FDA Albinus D'Sa, Deputy Director, India Office, FDA Nirupa Sen, Food and Medical Product Safety Coordinator, FDA DAY SIX: TUESDAY, JULY 3, 2012 NEW DELHI, INDIA 8:15-9:00 Working breakfast for committee members and staff at Crowne Plaza Hotel 9:00-10:30 Meeting with Serum Institute Sunil Bahl, Director, Business Development, Serum Institute of India Pramod Kumar, Senior Manager, Serum Institute of India 10:30-12:00 Meeting with Indian Pharmaceutical Alliance Dilip Shah, Secretary General, Indian Pharmaceutical Alliance 12:00-1:00 Lunch 1:00-1:30 Travel to Delhi Society for Promotion of Rational Use of Drugs 1:30-3:00 Meeting at Delhi Society for Promotion of Rational Use of Drugs Ranjit Chaudhury, Director, India-WHO Program in Rational Use of Drugs Usha Gupta, Executive Vice President, Delhi Society for Promotion of Rational Use of Drugs Read the entire page →
From page 348... ... 348 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS 3:00-3:30 Travel to Partnership for Safe Medicines India 3:30-5:00 Meeting at Partnership for Safe Medicines India Bejon Misra, Founder, Partnership for Safe Medicines India 5:00 Travel to airport 7:30 Flight to Hyderabad DAY SEVEN: WEDNESDAY, JULY 4, 2012 HYDERABAD, INDIA 7:30-8:15 Working breakfast for committee members and staff at Westin Hotel 8:15 Travel to USP-India 9:00-11:00 Overview of USP-India's activities and laboratory tour Koduru Surendra Nath, Senior Vice President, USP-India 11:00-12:00 Travel to Gland Pharma Limited 12:00-2:00 Lunch Meeting at Gland Pharma Limited Subhash Gouda, Deputy Manager, International Business, Gland Pharma Limited Srinivas Sadu, Chief Operating Officer, Gland Pharma Limited 2:00-3:00 Travel to Pharmexcil-India 3:00-4:30 Meeting with industry and industry associations P.V. Appaji, Director General, Pharmexcil India Meghana Inamdar, General Counsel and Managing Consultant, Sidvim Lifesciences Read the entire page →
From page 349... ... Santos, Corporate Security Manager, Pfizer Luciano Rosado, Quality Assurance Manager, Libbs Farmaceutica Group 10:45-11:30 Nicolina Romano-Lieber, Associate Professor, Department of Public Health Practices, School of Public Health, University of São Paulo 11:30-1:00 Lunch 1:00-1:45 Douglas Duarte, Technical Regulatory Manager, National Pharmaceutical Industries Association 1:45 Adjourn DAY TWO: TUESDAY, AUGUST 28, 2012 SÃO PAULO, BRAZIL 8:15-9:00 Working breakfast for committee members and staff at hotel Read the entire page →
From page 350... ... 350 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS 9:00 Travel to University of São Paulo 9:30-10:45 Fernando Nogueira, Professor, Federal University of Minas Gerais Claudio Cabral, Director of Quality, Cristália Laboratory Regina Zamith, Director, Global Brand Protection Latin America, Johnson & Johnson 10:45-11:00 Break 11:00-12:15 Terezinha Pinto, Professor, School of Pharmaceutical Sciences, University of São Paulo Filipe Soares Quirino da Silva, Director, Department Chemistry, National Institute for Health Quality, of Fiocruz Ediná Costa, Associate Professor, Institute of Collective Health, Federal University of Bahia 12:15-1:15 Lunch 1:15-2:30 Elize Massard, Postdoctoral Research Fellow, Center for Metropolitan Studies Aluisio Segurado, Professor, School of Medicine, Department of Infectious and Parasitic Diseases, University of São Paulo 2:30-3:00 Break 3:00-4:00 Frederico Benite, Principal Business Development Officer, International Finance Corporation/ World Bank Group Paulo Teixeira, Second Vice-President, National Federation of Pharmacists 4:00 Adjourn Read the entire page →
From page 351... ... APPENDIX C 351 DAY THREE: WEDNESDAY, AUGUST 29, 2012 BRASÍLIA, BRAZIL 7:15-8:00 Working breakfast for committee members and staff at hotel 8:00 Travel to Anvisa 9:00-10:00 Meeting with Anvisa's President Dirceu Barbano, President, Anvisa 10:00-10:30 Travel to PAHO 10:30-11:45 Meeting at PAHO Christophe Rerat, International Officer and Coordinator, Medicines Unit, Technology and Research, PAHO Flavia Poppe, Health Economist, Medicines Unit, Technology and Research, PAHO 11:45-12:15 Travel to Hotel Manhattan 12:15-2:00 Meeting at Hotel Manhattan Paola Manchesini, Technical Consultant, Malaria National Control Program, Brazilian Ministry of Health Marcia Almeida, Technical Consultant, Drug Management Department, National Malaria Control Program, Brazilian Ministry of Health Mayira Milano, International Consultant, Technical Unit for Non-Communicable and Communicable Diseases, PAHO 2:00-3:00 Lunch 3:00-3:30 Travel to Anvisa 3:30-5:00 Meeting with Anvisa's International Office Tiago Lanius Rauber, Director, Inspection and Control of Medicines and Products, Anvisa Patricia Oliveira Pereira, Deputy Director, International Health Regulations Unit, Division of International Affairs, Anvisa Leandro Teixeira de Morais, Specialist, International Health and Health Surveillance, Anvisa Read the entire page →

From page 339...

... Appendix C Meeting Agendas March 12-13, 2012 Meeting 1 -- Agenda Washington, DC DAY ONE: MONDAY, MARCH 12, 2012 Session 1 – Closed IOM Committee Process and Charge to Committee Room 204 Objective: 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. Session 2 – Open Questions on Statement of Task Room 100 11:10-11:30 Project Timeline and Statement of Task Sponsor Representative Introductions Larry Gostin, Committee Chair 11:30-11:45 The Charge to the Committee Jennifer Devine, Deputy Director, Global Regulatory Operations & Policy, FDA Kate Bond, Associate Director for Technical Cooperation and Capacity Building, FDA 11:45-12:15 Questions 339

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From page 340...

... 340 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS 12:15-1:15 Lunch Session 3 – Open Technologies for Detecting Unsafe Drugs Room 100 1:15-1:25 Welcome and Introductions Larry Gostin, Committee Chair 1:25-1:45 The Strengths and Weaknesses of the Detection Technologies Currently Available Mark Witkowski, Supervisory Chemist, Trace Examination Section, Forensic Chemistry Center, FDA 1:50-2:10 Importance of Reliable Detection Technologies in the Field Ashifi Gogo, Chief Executive, Sproxil 2:15-2:30 Break 2:30-2:50 Using Analytic Detection Technologies in Singapore Lim Chin Chin, Forensic Laboratory Director and Forensic Scientist, Singapore Health Science Authority 2:55-3:15 Using Analytic Detection Technologies in Peru Percy Alberto Ocampo Rujel, former Executive Director, Directorate of Control and Health Surveillance, Peru 3:20-3:40 Case Study on Merck's Use of Detection Technologies Anthony Zook, Director of Anti-Counterfeiting, Merck 3:45-4:30 Panel Discussion, The Future of Reliable Detection Technologies in the Field Patrick Lukulay, Moderator Session 4 – Closed Committee Planning

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From page 341...

... APPENDIX C 341 DAY TWO: TUESDAY, MARCH 13, 2012 ROOM 100 Session 5 – Open Framing and Defining the Problem 8:15-8:30 Opening Remarks Mary Lou Valdez, Associate Commissioner, Office of International Programs, FDA 8:45-9:45 Varying Interpretations of the Terms Counterfeit, Falsified, and Substandard Howard Zucker, Senior Advisor, Massachusetts General Hospital Rohit Malpani, Senior Advisor for Campaigns, Oxfam America Roger Bate, Legatum Fellow in Global Prosperity, American Enterprise Institute David R Gaugh, Vice-President for Regulatory Science, Generic Pharmaceutical Association 9:45-10:15 Panel Discussion on Terminology and the Problem of Fake Drugs Bryan Liang, Moderator 10:15-10:30 Break 10:30-11:45 Economic and Trade Interests in Counterfeit, Falsified, and Substandard Drugs Nicholas Cappuccino, Chief Executive, Pharmaceutical Intellectual Resource Services, LLC John Clark, Chief Security Officer and Vice President of Global Security, Pfizer Jamie Love, Director, Knowledge Ecology International 11:45-12:15 Panel Discussion on Health, Economic, and Trade Dimensions of the Problem Moderator Prashant Yadav, 12:15-1:15 Lunch

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From page 342...

... Department of Justice Jeffery Gren, Director, Office of Health and Consumer Goods, U.S. Department of Commerce Ilisa Bernstein, Director, Office of Compliance, Center for Drug Evaluation Research, FDA Margareth Ndomondo-Sigonda, Moderator 3:30-3:45 Break Session 7 – Open Scope of Work on the Problem 3:45-4:30 Investigating Trends and Analyzing Policy in Pharmaceutical Fraud Laurie Garrett, Senior Fellow for Global Health, Council on Foreign Relations Alan Coukell, Director Medical Programs, Pew Health Group Judit Rius, U.S.

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From page 343...

... DAY TWO: THURSDAY, MAY 10, 2012 ROOM 206 Session 5 – Open FDA Data on Fake Drugs 10:30-11:30 The FDA's estimates of the scope of the problem Jen Devine, Regulatory Counsel, CDER Office of Compliance 11:30-12:00 Questions June 26-July 4, 2012 Travel Meeting -- Agenda Geneva, London, New Delhi, Hyderabad DAY ONE: TUESDAY, JUNE 26, 2012 GENEVA, SWITZERLAND 3:15-3:30 Travel to Global Fund 3:30-5:00 Meeting at Global Fund Joelle Daviaud, Quality Assurance Specialist and Grant Management Support, the Global Fund to Fight AIDS, Tuberculosis, and Malaria

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From page 344...

... 344 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Mariatou Tala Jallow, Manager, Procurement Support Service, the Global Fund to Fight AIDS, Tuberculosis, and Malaria DAY TWO: WEDNESDAY, JUNE 27, 2012 GENEVA, SWITZERLAND 9:15-10:00 Working breakfast for committee members and staff at Movenpick Hotel 10:30-11:30 Amir Attaran, Associate Professor, Faculties of Law and Medicine, University of Ottawa 12:30-1:45 Lunch 1:45-2:00 Travel to South Centre 2:00-3:30 Meeting at South Centre German Velasquez, Senior Advisor of Health and Development, South Centre Nirmalya Syam, Program Officer, Innovation and Access to Knowledge Program, South Centre 3:30-4:00 Travel to NGO Forum for Health 4:00-5:00 Meeting with NGO Forum for Health Alan Leather, President, NGO Forum for Health DAY THREE: THURSDAY, JUNE 28, 2012 GENEVA, SWITZERLAND 8:30-9:15 Working breakfast for committee members and staff at Movenpick Hotel 9:15-9:30 Travel to WHO 9:30-11:00 Meeting at WHO with Interpol Aline Plançon, Enforcement Officer, Interpol Naill Sargent, Criminal Intelligence Analyst, Interpol 11:45-12:00 Travel to Third World Network

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From page 345...

... APPENDIX C 345 12:00-1:30 Meeting at Third World Network Sangeeta Shashikant, Legal Advisor, Third World Network 1:30-2:15 Lunch 2:15-2:30 Travel to WHO 2:30-5:00 Meeting at WHO Kees de Joncheere, Regional Adviser, Health Technology and Pharmaceuticals, WHO Sabine Kopp, Manager, Medicines Quality Assurance Program, WHO Michele Forzley, Professor, Widener School of Law and Georgetown School of Law DAY FOUR: FRIDAY, JUNE 29, 2012 LONDON, ENGLAND 8:30-9:45 Working breakfast for committee members and staff at Thistle Grosvenor Hotel 9:45 Travel to EMA 10:30-12:00 Meeting at EMA Emer Cooke, Acting Head, International and European Cooperation, EMA 12:00-1:30 Lunch 1:30-2:00 Travel to Chatham House 2:00-5:00 Meeting at Chatham House Charles Clift, Senior Research Consultant, Centre on Global Health Security, Chatham House Paul Newton, Director, Wellcome Trust-Mahosot Hospital-Oxford University Tropical Medicine Research Collaboration Harparkash Kaur, Professor, London School of Hygiene and Tropical Medicine Sharon Peacock, Professor, University of Cambridge Simeon Wilson, Director, Global Security, AstraZeneca

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From page 346...

... 346 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Paul Ellis, Director, External Advocacy, GlaxoSmithKline Mohga Kamal-Yanni, Senior Health and HIV Policy Adviser, Acting Team Lead Development Finance and Public Service, Oxfam Philippa Saunders, Consultant Wendy Greenall, Counterfeit Medicines Laboratory Manager, Pfizer Greg Perry, Director General, European Generic Medicines Association Francis Roodt, Intellectual Property Office Lynda Scammell, Senior Policy Manager and Relationship Manager, Enforcement Group, Medicines and Healthcare Products Regulatory Agency DAY FIVE: MONDAY, JULY 2, 2012 NEW DELHI, INDIA 7:00-7:45 Working breakfast for committee members and staff at Crowne Plaza Hotel 7:45 Travel to PATH 8:30-10:00 Meeting at PATH Raj Shankar Ghosh, Technical Director, PATH Sonali Kochhar, Medical Director, PATH Pritu Dhalaria, Director, Immunization Projects, PATH Satish Kaipilyawar, Project Director, TB Program, PATH 10:00-11:00 Travel to Ministry of Health and Family Welfare 11:00-12:30 Meeting at Ministry of Health and Family Welfare L.C. Goyal, Additional Secretary and Director General, Central Government Scheme, Ministry of Health and Family Welfare Arun Panda, Joint Secretary, Ministry of Health and Family Welfare 12:30-1:30 Lunch

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From page 347...

... FDA Bruce Ross, Director, India Office, FDA Regina Brown, Assistant Director of Medicines, FDA Albinus D'Sa, Deputy Director, India Office, FDA Nirupa Sen, Food and Medical Product Safety Coordinator, FDA DAY SIX: TUESDAY, JULY 3, 2012 NEW DELHI, INDIA 8:15-9:00 Working breakfast for committee members and staff at Crowne Plaza Hotel 9:00-10:30 Meeting with Serum Institute Sunil Bahl, Director, Business Development, Serum Institute of India Pramod Kumar, Senior Manager, Serum Institute of India 10:30-12:00 Meeting with Indian Pharmaceutical Alliance Dilip Shah, Secretary General, Indian Pharmaceutical Alliance 12:00-1:00 Lunch 1:00-1:30 Travel to Delhi Society for Promotion of Rational Use of Drugs 1:30-3:00 Meeting at Delhi Society for Promotion of Rational Use of Drugs Ranjit Chaudhury, Director, India-WHO Program in Rational Use of Drugs Usha Gupta, Executive Vice President, Delhi Society for Promotion of Rational Use of Drugs

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From page 348...

... 348 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS 3:00-3:30 Travel to Partnership for Safe Medicines India 3:30-5:00 Meeting at Partnership for Safe Medicines India Bejon Misra, Founder, Partnership for Safe Medicines India 5:00 Travel to airport 7:30 Flight to Hyderabad DAY SEVEN: WEDNESDAY, JULY 4, 2012 HYDERABAD, INDIA 7:30-8:15 Working breakfast for committee members and staff at Westin Hotel 8:15 Travel to USP-India 9:00-11:00 Overview of USP-India's activities and laboratory tour Koduru Surendra Nath, Senior Vice President, USP-India 11:00-12:00 Travel to Gland Pharma Limited 12:00-2:00 Lunch Meeting at Gland Pharma Limited Subhash Gouda, Deputy Manager, International Business, Gland Pharma Limited Srinivas Sadu, Chief Operating Officer, Gland Pharma Limited 2:00-3:00 Travel to Pharmexcil-India 3:00-4:30 Meeting with industry and industry associations P.V. Appaji, Director General, Pharmexcil India Meghana Inamdar, General Counsel and Managing Consultant, Sidvim Lifesciences

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From page 349...

... Santos, Corporate Security Manager, Pfizer Luciano Rosado, Quality Assurance Manager, Libbs Farmaceutica Group 10:45-11:30 Nicolina Romano-Lieber, Associate Professor, Department of Public Health Practices, School of Public Health, University of São Paulo 11:30-1:00 Lunch 1:00-1:45 Douglas Duarte, Technical Regulatory Manager, National Pharmaceutical Industries Association 1:45 Adjourn DAY TWO: TUESDAY, AUGUST 28, 2012 SÃO PAULO, BRAZIL 8:15-9:00 Working breakfast for committee members and staff at hotel

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From page 350...

... 350 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS 9:00 Travel to University of São Paulo 9:30-10:45 Fernando Nogueira, Professor, Federal University of Minas Gerais Claudio Cabral, Director of Quality, Cristália Laboratory Regina Zamith, Director, Global Brand Protection Latin America, Johnson & Johnson 10:45-11:00 Break 11:00-12:15 Terezinha Pinto, Professor, School of Pharmaceutical Sciences, University of São Paulo Filipe Soares Quirino da Silva, Director, Department Chemistry, National Institute for Health Quality, of Fiocruz Ediná Costa, Associate Professor, Institute of Collective Health, Federal University of Bahia 12:15-1:15 Lunch 1:15-2:30 Elize Massard, Postdoctoral Research Fellow, Center for Metropolitan Studies Aluisio Segurado, Professor, School of Medicine, Department of Infectious and Parasitic Diseases, University of São Paulo 2:30-3:00 Break 3:00-4:00 Frederico Benite, Principal Business Development Officer, International Finance Corporation/ World Bank Group Paulo Teixeira, Second Vice-President, National Federation of Pharmacists 4:00 Adjourn

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From page 351...

... APPENDIX C 351 DAY THREE: WEDNESDAY, AUGUST 29, 2012 BRASÍLIA, BRAZIL 7:15-8:00 Working breakfast for committee members and staff at hotel 8:00 Travel to Anvisa 9:00-10:00 Meeting with Anvisa's President Dirceu Barbano, President, Anvisa 10:00-10:30 Travel to PAHO 10:30-11:45 Meeting at PAHO Christophe Rerat, International Officer and Coordinator, Medicines Unit, Technology and Research, PAHO Flavia Poppe, Health Economist, Medicines Unit, Technology and Research, PAHO 11:45-12:15 Travel to Hotel Manhattan 12:15-2:00 Meeting at Hotel Manhattan Paola Manchesini, Technical Consultant, Malaria National Control Program, Brazilian Ministry of Health Marcia Almeida, Technical Consultant, Drug Management Department, National Malaria Control Program, Brazilian Ministry of Health Mayira Milano, International Consultant, Technical Unit for Non-Communicable and Communicable Diseases, PAHO 2:00-3:00 Lunch 3:00-3:30 Travel to Anvisa 3:30-5:00 Meeting with Anvisa's International Office Tiago Lanius Rauber, Director, Inspection and Control of Medicines and Products, Anvisa Patricia Oliveira Pereira, Deputy Director, International Health Regulations Unit, Division of International Affairs, Anvisa Leandro Teixeira de Morais, Specialist, International Health and Health Surveillance, Anvisa

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Appendix C: Meeting Agendas Pages 339-352

Appendix C: Meeting Agendas
Pages 339-352