The U.S. Pharmacopeial Convention (USP) is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected. USP’s Global Health programs work with donors and partners in low- and middle-income countries to advance access to quality-assured essential medical products and strengthen supply chains to address critical global health threats such as COVID-19, tuberculosis, HIV and AIDS, and maternal and child health conditions.
The Promoting the Quality of Medicines Plus (PQM+) program is a five-year U.S. Agency for International Development (USAID)-funded cooperative agreement with a goal to sustainably strengthen medical product quality assurance systems in low- and middle-income countries (LMICs). PQM+ provides technical assistance to Medicines Regulatory Authorities in a number of countries in Asia. This cooperative relationship supports the Drug Regulatory Authority of Pakistan (DRAP) for regulatory reforms, quality assurance systems, and strengthening the quality control laboratories in Pakistan. Moreover, PQM+ also provides technical capacity building in close coordination with DRAP and provincial health authorities.
USP seeks an international Bio studies consultant to support DRAP for development strategy to implement BE studies in Pakistan and conduct training of DRAP staff on Good Clinical Practices as well as CT assessment. The consultant will also provide technical assistance to National BE centers to conduct real-time BE studies at their centers as per international best practices. The Consultant(s) will be called to work on an as-needed basis, under specific Work Orders, and will report to the Consultant Supervisor listed on the Work Order. USP - PQM+ Pakistan team would like to hire a regulatory consultant who will work to provide regulatory system-strengthening support to manufacturers/stakeholders. Under the overall direction of the PQM+ Chief of Party the Individual will:
1.Training of National BE study centers on BE studies protocol writing as per international best practices.
2. Review draft protocol for real time BE studies prepared by Selected BE Centers
3. Support and coach BE centers during real time BE Studies
4. Support DRAP to develop strategy for implementation and mechanism for Biostudies regulatory approval.
5. Training of BE centers on statistical analysis and interpretation of results/data
6. Training of BE Centers on critical aspects of BE studies
7. Organize training for DRAP staff on Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) based on the International Council for Harmonization (ICH) guidelines.
1. At least a PHD Doctorate in degree in Pharmaceutical Sciences.
2. At least Twenty years’ experience in pharmacokinetics or bio pharmaceutics or bio equivalence testing.
3. International Proven Experience with Reference Authorities.
4. Hands-on experience and work understanding of pharmacokinetics and/or bioequivalence studies.
5. Demonstrated ability in developing policies, regulations, and guidelines related to biopharmaceutics or pharmacokinetics or related field.
6. Demonstrated ability to lead professionals and manage others through influence and collaboration.
7. Demonstrated ability to conduct and interpret quantitative/qualitative information with analytical problem-solving.
8. Proven leadership skills in consulting with demonstrated experience in training and mentoring staff and others.
9. Excellent oral and written communication skills in English; knowledge of the local language is desired.
10. Must demonstrate an understanding of the operations, health policy trends, and any applicable regulations related to the responsible technical area.
1. Training report and presentation on a statistical analysis of clinical data
2. Report of Training of DRAP staff on GCP/GLP
3. Reports of Training of DRAP staff on assessment of Clinical Study Reports
4. Training of BE Centers on critical aspects of conducting BE studies
5. BE Studies Protocols
Submission of Report and Invoice for the Programmatic Deliverables
Estimated Due Date
September 30th, 2023
PERIOD OF PERFORMANCE
The anticipated period of performance will be March 1st, 2023 to September 30th, 2023. The Anticipated Contract Type is a Master Agreement and Work Orders will issue under MCA. The assignment will be required a maximum of a 25 Working Days Level of Effort (LOE).
The individual will work with the USP Pakistan team based at Islamabad Office. (Full-Time/Hybrid Mode).
1. Previous Experience - 40%
2. Qualification and Education - 40%
3. Financial Proposal- 20%
The applicant is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.
pThe 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. Our mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP envisions a world in which all have access to high quality, safe, and beneficial medicines and foods. USP approaches this vision with a sense of urgency and purpose, strengthened by its cadre of dedicated volunteers, members, and staff, and by working collaboratively with key stakeholders across the globe. As the world gets smaller and more connected, quality issues affect everyone. Diseases travel. Drug resistance grows. Fake medicines kill. The foundation of quality we’re building helps address these and other global health issues. Whether decreasing the prevalence of substandard and poor-quality medicines or helping to curb antimicrobial resistance, we’re there working to protect the health of people all over the world./p