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



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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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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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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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342 COUNTERING THE PROBLEM OF FALSIFIED AND SUBSTANDARD DRUGS Session 6 – Open National and International Collaboration 1:15-2:15 Enforcement in Pharmaceutical Fraud Susanne Keitel, Director, European Directorate for  Quality of Medicines and Healthcare, Council of Europe Aline Plançon, Manager, Interpol Medical Products  Counterfeiting and Pharmaceutical Crime Unit (by video conference) Sebastian Mollo, Intelligence Director, Pharmaceutical Security Institute Sameer Barde, Federation Indian Chambers of Commerce and Industry Daniel Carpenter, Moderator 2:25-3:30 U.S. Government Work Against Pharmaceutical Fraud Catherine Hill-Herndon, Director, Office of  International Health and Biodefense, U.S. Department of State Linda Marks, Attorney, U.S. 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. Manager of the Campaign for Access to Essential Medicines, Doctors Without Borders Ann Marie Kimball, Moderator

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APPENDIX C 343 4:30-5:00 Closing Remarks Larry Gostin, Committee Chair 5:00 Adjourn May 9-10, 2012 Meeting 2—Agenda Washington, DC DAY ONE: WEDNESDAY, MAY 9, 2012 ROOM 110 All sessions were closed. Committee members discussed the report and potential conclusions and recommendations. 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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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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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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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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APPENDIX C 347 1:30-2:00 Travel to Pharmacy Council of India 2:00-3:00 Meeting at Pharmacy Council of India Archana Mudgal, Pharmacy Council of India 3:00-3:30 Travel to U.S. Embassy 3:30-5:00 Meeting at U.S. 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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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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APPENDIX C 349 August 27-29, 2012 Travel Meeting—Agenda São Paulo and Brazília, Brazil DAY 1: MONDAY, AUGUST 27, 2012 SÃO PAULO, BRAZIL 8:15-9:00 Working breakfast for committee members and staff at hotel 9:00 Travel to University of São Paulo 9:30-10:45 Débora Germano, Associate Director, Regulatory Affairs, Pfizer Claudia Lima, Latin America Packaging Operational Services Manager, Pfizer Rodrigo Lozano, Director, Distribution Center Operations, Pfizer Erica M. Varise, Compliance Manager, Logistics Operations, Pfizer Alberto C. 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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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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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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