Consultant - GMP Training Module Development (1116-679)

Location
Rockville, Maryland, United States
Posted
Jun 05, 2018
Closes
Jul 13, 2018
Hours
Full Time

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. Please read full detailed instructions for applications below. Submissions must be sent 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.

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.

Job Location Rockville, Maryland, United States Position Type Consulting

Similar jobs