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 |
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
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 Prashant Yadav, Moderator |
12:15-1:15 |
Lunch |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 of Chemistry, National Institute for Health Quality, 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 |
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 |