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Contribution to the Global Plan |
Declaration |
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Organization Contact Information |
Name: |
Promoting the Quality of Medicine (PQM) Program, United States Pharmacopeia |
Street 1: |
12601 Twinbrook Parkway |
Street 2: |
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City: |
Rockville |
Province: |
MD |
Post Code: |
20852 |
Country: |
United States of America |
Phone: |
1.301.881.0666 |
Organization Email: |
pqm@usp.org |
Web Site: |
http://www.pqmusp.org/ |
Other Online Presence: |
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Focal Point Contact Information |
Salutation: |
Dr. |
First Name: |
Patrick |
Last Name: |
Lukulay |
Title: |
Director, Promoting the Quality of Medicines Program |
Email: |
phl@usp.org |
Phone: |
1.301.816.8166 |
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Alternate Focal Point Contact Information |
Salutation: |
Mr. |
First Name: |
Edwin |
Last Name: |
Toledo |
Title: |
Program Manager/Senior GMP Specialist |
Email: |
ert@usp.org |
Phone: |
1.301.816.8165 |
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General Information |
Board Constituency: |
Developed Country NGO |
Is your organization legally registered in your country: |
Yes |
If yes, please enter your registration number: |
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Organization Type - Primary: |
Non-Governmental Organization |
Organization Type - Secondary: |
Other Non-Governmental Organization (NGO) |
Organization Description: |
The Promoting the Quality of Medicines (PQM) program, funded by the U.S. Agency for International Development (USAID) and implemented by the United States Pharmacopeia (USP), is USAID’s response to the growing challenge posed by the proliferation of counterfeit and substandard medicines. By providing technical leadership to developing countries, PQM helps build local capacity in medicines quality assurance systems, increase the supply of quality medicines to priority USAID health programs, and ensure the quality and safety of medicines globally.
PQM provides technical assistance to USAID priority countries to help them improve their capacity for monitoring the quality of anti-TB and other medicines circulating in their markets. PQM also works with the World Health Organization (WHO) and the Global Drug Facility to identify manufacturers of second-line anti-TB medicines and assist them in becoming WHO prequalified (able to meet internationally-accepted standards of medicines manufacturer)to increase the pool of quality-assured anti-TB products available locally, regionally, and globally. |
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Do you know about the UNHLM declaration: |
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Specializations / Areas of Work |
Advocacy Funding, including innovative and optimized approach to funding TB Care Technical Assistance |
Other Organization Information |
Total number of staff in your organization: |
11 - 25 |
Number of full-time staff who are directly involved with TB: |
1 - 5 |
Number of part-time staff who are directly involved with TB: |
1 - 5 |
Number of volunteers who are directly involved with TB: |
0 |
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How did you hear about the Stop TB Partnership: |
Other partners |
If you were informed or referred by another partner of the Stop TB Partnership please tell us who: |
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Why do you wish join the Stop TB Partnership: |
Technical assistance and advice |
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Are you a member of a Stop TB national partnership: |
No |
Are you in contact with your national TB programme: |
No |
Please tell us how your organization is contributing to your country's national TB control plan: |
PQM works solely with USAID priority countries. |
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Geographical Reach |
Which country is your headquarters located in: |
United States of America |
Which countries do you do operate in: (This includes countries you are conducting activities in) |
Bangladesh Benin Bolivia Brazil Cambodia Colombia Ecuador Ethiopia Ghana Guatemala Guyana India Indonesia Kazakhstan Kenya Lao People's Democratic Republic Liberia Mali Mozambique Myanmar Nepal Panama Paraguay Peru Philippines Russian Federation Rwanda Senegal Suriname Thailand United Republic of Tanzania Viet Nam |
Contribution |
Please tell us how your organization will contribute to the Global Plan to Stop TB by briefly describing its involvement in any of the areas of work listed below: |
TB Care Delivery: Increase use of effective interventions to reduce the threat of infectious diseases, including tuberculosis, by developing USP pharmacopeial methods for testing a fixed-dose combination (FDC) tablet important in implementing DOTS. Raise public awareness about the dangers of counterfeit and substandard medicines by (1) broadcasting public service announcements in Cambodia, Laos, Thailand, and Vietnam, and contributing to productions of regional and global documentary films on counterfeit medicines; and, (2) support outreach activities of national and grassroots community organizations in Cambodia, Laos, Thailand, Vietnam, and Senegal.
Drug-Resistant TB: Increase availability of quality-assured second-line anti-tuberculosis (SL-ATB) medicines by (1) conducting workshops with GDF in countries with a high burden of TB to identify and provide technical assistance to SL-ATB medicines manufacturers on compliance with internationally accepted manufacturing standards;(2) providing technical assistance to SL-ATB medicines manufacturers that are seeking WHO prequalification; (3) working closely with GDF, WHO, and the Green Light Committee (GLC) on related activities, and participating in the Steering Working Group and WHO PQ Assessors Meetings and Assessment Trainings; (4)providing up-to-date information describing PQM technical assistance available; and, (5) developing analytical methods to test for quality of anti-TB medicines and train local analysts on their use.
TB-HIV: Increase availability of quality-assured second-line anti-tuberculosis (SL-ATB) medicines by (1) conducting workshops with GDF in countries with a high burden of TB to identify and provide technical assistance to SL-ATB medicines manufacturers on compliance with internationally accepted manufacturing standards;(2) providing technical assistance to SL-ATB medicines manufacturers that are seeking WHO prequalification; (3) working closely with GDF, WHO, and the Green Light Committee (GLC) on related activities, and participating in the Steering Working Group and WHO PQ Assessors Meetings and Assessment Trainings; (4)providing up-to-date information describing PQM technical assistance available; and, (5) developing analytical methods to test for quality of anti-TB medicines and train local analysts on their use.
Laboratory Strengthening: Strengthen national and regional capacities in medicines regulation, quality assurance/quality control systems and enforcement by (1)continuing and expanding the medicines quality monitoring of anti-infective medicines in order to obtain evidence-based data to support policy decision-making and enforcement; and, (2) building the capacity of national quality control laboratories in pharmaceutical analysis.
Research: Reduce the prevalence of substandard and counterfeit TB medicines by conducting quality surveys and developing a database of suppliers of quality-assured API Help obtain evidence-based data on the quality of ATB medicines through a regional monitoring mechanism. |
Declaration |
Declaration of interests:
Technical Assistance-Medicines Quality Assurance
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Application date: |
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Last updated: |
January 4, 2012 |
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