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Contact General Specializations in Countries 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:
City: Rockville
Province: MD
Post Code: 20852
Country: United States of America
Phone: 1.301.881.0666
Email: pqm@usp.org
Web Site: http://www.pqmusp.org/

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

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

General Information

Organization Type - Primary: Non-Governmental Organization
Organization Type - Secondary: Other Non-Governmental Organization (NGO)
Is your organization legally registered in your country: Yes
Organization Reach: International
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.
 
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
 
What is your organization's annual budget (USD) dedicated to TB? $1 MIL-$10 MIL
How did you hear about the Stop TB Partnership: Other partners
Why do you wish join the Stop TB Partnership: Technical assistance and advice
 
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.
 

Geographical Reach

Which country is your headquarters located in: United States of America
Which WHO region is the main focus of your work: Global
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

Specializations

Advocacy, communication and social mobilization
Funding
Funding
Technical Assistance
Technical Assistance

Specializations in Countries

Advocacy, communication and social mobilization Cambodia
Advocacy, communication and social mobilization Lao People's Democratic Republic
Advocacy, communication and social mobilization Senegal
Advocacy, communication and social mobilization Thailand
Advocacy, communication and social mobilization Viet Nam
Technical Assistance Bangladesh
Technical Assistance Benin
Technical Assistance Bolivia
Technical Assistance Brazil
Technical Assistance Cambodia
Technical Assistance Colombia
Technical Assistance Ecuador
Technical Assistance Ethiopia
Technical Assistance Ghana
Technical Assistance Guatemala
Technical Assistance Guyana
Technical Assistance India
Technical Assistance Indonesia
Technical Assistance Kazakhstan
Technical Assistance Kenya
Technical Assistance Lao People's Democratic Republic
Technical Assistance Liberia
Technical Assistance Mali
Technical Assistance Mozambique
Technical Assistance Myanmar
Technical Assistance Nepal
Technical Assistance Panama
Technical Assistance Paraguay
Technical Assistance Peru
Technical Assistance Philippines
Technical Assistance Russian Federation
Technical Assistance Rwanda
Technical Assistance Senegal
Technical Assistance Suriname
Technical Assistance Thailand
Technical Assistance United Republic of Tanzania
Technical Assistance 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:

DOTS Expansion and Enhancement:
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.

Operational 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

Application date:  
Last updated: January 4, 2012