SCOPE OF WORK (SOW) TO PROVIDE SERVICES AS FOR INTERNATIONAL BIO EQUIVALENCE STUDY SYSTEM CONSULTANT
ACTIVITY BACKGROUNDThe safety and efficacy of generic chemical drugs assume that the API is safe and chemically identical, and its absorption is comparable to a reference product. There is no need for clinical efficacy testing in patients if the presumptions of generic comparability are met. It is, however, necessary to prove that produced brand of the generic drug has the same quality, safety, and efficacy as the original (originator’s/ comparator’s) drug by carrying out Bioavailability/ Bioequivalence (BA/BE) studies of the drug. This need has led to the rapid creation of the facilities for BA/BE studies of drugs in Pakistan. The requirement for establishment of these centers for BA/BE studies are very stringent. For strengthening and national capacity building to conduct BE Studies.
USP - PQM+ Pakistan team would like to hire a International Consultant who will provide regulatory technical Assistance to selected BE Study Centers for development of system in compliance with international best practices to conduct BE Studies. Under the overall direction of PQM+ Chief of Party the entity/Individual will:
1. Conduct gap assessment of selected BE Centers
2. Support BESC for preparation of CAPA against observation of gap assessment report
3. Provide technical assistance to BESC to develop SOPs
4. Training of BESC on GCP/GLP
5. Training of BSSC on mock studies preparation and submission
6. Training of BESC Staff on Guidelines for BE Studies
7. Training on statistical data analysis and data interpretations
8. Training of BESC Staff for Study Protocols & Reports writing
MANDATORY DELIVERABLES1. Gap Assessment Reports
2. CAPA Plan and progress
3. Mock study protocol preparation and submission
4. Training materials
5. Training reports
MINIMUM REQUIREMENTS1. At least a Masters in degree in Pharmaceutical Sciences.
2. At least Twenty years’ experience in pharmacokinetics or biopharmaceutics or bioequivalence 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.
PERIOD OF PERFORMANCE
The scope of the work defined herein should be implemented within the years 2021-2022 between, the assignment will be for 25 working days from the date of the sign of the contract.
GEOGRAPHIC AREA
Selected firm/ individual will develop and work remotely in consultation with the USP Pakistan team and DRAP team.
REPORTINGSelected firm/ individual will report to the PQM+ Chief of Party.
EVALUATION CRITERIA1. Past Experience - 40%
2. Qualification and Education - 35%
3. Financial Proposal- 25%
INSTRUCTIONS: The Consultant is required to have the aforementioned professional and technical qualifications. Only the applicants who hold these qualifications** will be shortlisted and contacted. IMPORTANT NOTE
Please send CV/Profile, 3-References, and Daily Rate by downloading the following ANNEX – D (Template):
https://drive.google.com/file/d/1SNQftPHB25vpRZTcznnsDrFRB8d2r7d1/view?usp=sharing
The Quoted Per Day Rate (USD) should be inclusive of all applicable taxes.
Kindly send all Technical and Financial Proposals to ATTN: USP Pakistan Procurement at Pak_procurement@USP.org before the closing date (December, 9th 2021). When submitting your application, write “International BESC Support Consultant” in the email Subject Line.
The U.S. Pharmacopeial Convention (USP) is a scientific non-profit 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 are 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 are there working to protect the health of people all over the world.
PQM+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.
