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[e-drug] Seeking contractor to develop online GMP training modules

E-DRUG: Seeking contractor to develop online GMP training modules
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Dear All,

The Promoting the Quality of Medicines (PQM) program funded by USAID and
implemented by U.S. Pharmacopeial Convention (USP) is seeking a
contractor/vendor to develop online GMP training modules. The application
due date is June 22, 2018.

Please see link

<https://drive.google.com/open?id=1yr7u9T1HozhiCFOq9TQLD3lfVdqJEifX>

 (and information pasted below) for details.

Regards,

Jenny Derry

Request for Applications for Development of Online GMP Training Modules 
in support of Promoting the Quality of Medicines (PQM) program

USAID Cooperative Agreement No. AID-GHS-A-00-09-00003-00
Issuance Date: June 4, 2018 

Submit Expression of Interest to: 
Ms. Sona Karia (SOK@usp.org)

Closing Date for Submission of Expressions of Interest: *June 22, 2018*

Managed by
U.S. Pharmacopeial Convention (USP)

Funded by
U.S. Agency for International Development

Introduction:

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit
organization that sets standards for the identity, strength, quality, and
purity of medicines, food ingredients, and dietary supplements
manufactured, distributed, and consumed worldwide. USP's drug standards are
enforceable in the United States by the Food and Drug Administration (FDA),
and these standards are used in more than 140 countries.

The 'Promoting the Quality of Medicines (PQM) program' is a program funded by
the U.S. Agency for International Development (USAID) and implemented by
USP. 

Since 1992, USP has worked in partnership with USAID to support low-
and middle-income countries (LMICs) in addressing critical issues related
to medicines quality. The PQM program provides technical assistance to
build the capacity of medicines regulatory authorities and quality
assurance systems in countries with emergent health systems, and it
supports manufacturing of quality-assured priority essential medicines for
malaria; HIV/AIDS; tuberculosis; neglected tropical diseases; and maternal,
newborn and child health. 

There is increasing recognition of the burden of
poor-quality medicines and their threat to public health, especially in
LMICs. Falsified and substandard medicines can cause treatment failure and
adverse reactions, can increase morbidity and mortality, and may contribute
to antimicrobial resistance. These medicines represent not only a waste of
scarce resources but also a substantial risk to public health. Further,
they risk undermining decades of health investments, including those made
by USAID.

One of PQM's key technical competences is capacity development in good
manufacturing practices (GMP). Since 2009, PQM has trained approximately
2,000 individuals on different GMP topics. PQM's interaction with the
manufacturers shows that there is a need to make GMP training accessible to
an even wider audience. To respond to this need, PQM will develop an online
GMP training course.

Working under the guidance of PQM staff, the selected contractor/vendor
will be responsible for developing a series of online learning modules
related to GMP; chemistry, manufacturing, and controls (CMC);
bioequivalence (BE) studies; and/or good clinical practices (GCP). These
online modules will be accessed by regulators and pharmaceutical industry
personnel working in LMICs to assure the quality of essential medicines.
  
Scope of Work:

In collaboration with USP PQM staff, the selected contractor/vendor will:

·         Develop at least 10 online learning modules related to GMP, CMC,
BE studies, and/or GCP, which will target regulators and pharmaceutical
industry professionals, mostly from LMICs, with knowledge ranging from
beginner and intermediate to advanced levels. In the proposal, the
applicant should propose module topics for PQM's review and selection.

·         Reference regulatory guidance from ICH, the World Health
Organization, the European Medicines Agency, and U.S. FDA in developing the
modules.

·         Include the following in each module:

o   Pre- and post- tests to determine improvement of knowledge.

o   Learning management system analytics to determine the participants'
engagement through metrics such as time on task, completion rate, number of
attempts, and any other analytics as determined necessary by the applicant.
Deliverables and Timeline:

The deliverable of the project is at least 10 online learning modules
related to GMP, CMC, BE studies, and/or GCP approved by USP PQM staff. All
approved modules should be developed and activated within 6 months of
executing the contract.

This project can be completed in a phased approach. The online training
modules could be developed in the different phases according to the
following categories: GMP, CMC, GCP, and BE. The proposal should include a
timeline and cost for module development by phases outlined in the proposal.

The selected contractor/vendor (signing the executed contract) will be the
sole party responsible for delivering the final product. All materials
developed under this assignment will belong solely to USAID and PQM.

Evaluation Criteria:

·         Comprehensive proposal for development of the online learning
modules covering the following technical areas: GMP, CMC, BE, and/or GCP.

·         Demonstrated strong knowledge and experience in GMP, CMC, BE
studies, and/or GCP.

·         Relevant experience in the development of online training modules.

·         Cost-effective proposal.
Application Submission Requirements:

Applications must contain the following:

Individual Applications:

   1. Cover letter expressing the applicant's interest in developing online
   learning modules covering the following technical areas: GMP, CMC, BE,
   and/or GCP.
   2. Proposal for the development of the online learning modules,
   including a timeline and cost.
   3. Information demonstrating knowledge and experience in GMP, CMC, BE
   studies, and/or GCP.
   4. Information demonstrating experience in the development of online
   learning courses.
   5. USAID Form 1420 (available at http://www.usaid.gov/sites/
   default/files/AID1420-17.doc)

Business/Organizations Applications:

   1. Cover letter expressing the applicant's interest in developing online
   learning modules covering the following technical areas: GMP, CMC, BE,
   and/or GCP.
   2. Proposal for the development of the online learning modules,
   including a timeline and cost.
   3. Information demonstrating knowledge and experience in GMP, CMC, BE
   studies, and/or GCP.
   4. Information demonstrating experience in the development of online
   learning courses.

If the applicant is submitting a joint proposal with more than one
organization, the proposal should be limited to only two parties and should
clearly identify the party that will be primarily accountable for the
project. During the selection process, due diligence will be conducted on
all parties involved in the proposal.

The following information must be submitted to Sona Karia at 
SOK@usp.org 
by June 22, 2018. 
Any applications received after this date will not be
considered. Clearly state 'PQM call for online GMP training modules' in the
subject line of the application email. Only applications sent to this email
address will be considered.

Jennifer Park 
for USP PQM Program
<jpark2004@gmail.com>
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