International BE Studies Consultant

ABOUT US

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.

PQM+ 

The Promoting the Quality of Medicines Plus (PQM+) program[1] 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.

ROLE OVERVIEW

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:

KEY RESPONSIBILITIES

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. 

QUALIFICATIONS

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.

DELIVERABLES

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

MODE

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).

GEOGRAPHIC AREA

The individual will work with the USP Pakistan team based at Islamabad Office. (Full-Time/Hybrid Mode).

EVALUATION CRITERIA 

1. Previous Experience - 40%

2. Qualification and Education - 40%

3.  Financial Proposal- 20%

INSTRUCTIONS

The applicant is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications will be shortlisted and contacted.