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.

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.

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.

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

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.

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).