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Countering the Problem of Falsified and Substandard Drugs (2013)

Chapter: Appendix C: Meeting Agendas

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Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
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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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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

Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×

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×
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×
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Suggested Citation:"Appendix C: Meeting Agendas." Institute of Medicine. 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. doi: 10.17226/18272.
×
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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today.

The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

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