ABOUT US

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.

ACTIVITY BACKGROUND

 USP - PQM+ Pakistan team would like to hire a consultant who will design a short course for Regulatory Sciences. The program will globally cover regulatory affairs, including the application of regulatory principles worldwide. The program will not be limited to regulatory affairs, and features lectures and student activities that span the discovery of drugs/biologics to post-market activities, with a scientific emphasis on development pathways, including common challenges and science-based solutions. The consultant will create a repository with key resources to help inform the development of the course modules (e.g., WHO guidelines, PQM+ technical document series and previously developed training material, among other reference materials). Moreover, in collaboration with selected local academic institutions, the program will develop a roadmap that will help guide the academic institution in the development and future adoption of the course.

CONSULTANT RESPONSIBILITIES:

1. Desk review for recent international requirements in quality assurance and regulatory affairs as a part of course content in other international universities/pharmacy schools.
2. Draft Course contents, learning objectives and resources
3. Hold a consultative meeting with the Drug Regulatory Authority of Pakistan (DRAP) and Pharmaceutical Industries to share and get feedback upon draft course contents
4. Hold a consultative meeting with the Higher education commission (HEC) and Pharmacy Council of Pakistan (PCP) for vetting and approval of the course
5. Develop a course assessment and qualification criteria
6. Finalize the course contents
7. Propose credit hours as per requirements of the Pharmacy Council of Pakistan (PCP) and Higher education commission (HEC)
8. Develop a repository of reference material
9. Develop a roadmap for academic institutions for adoption and implementation of the course

MANDATORY DELIVERABLES

MINIMUM REQUIREMENTS 

1. PhD. degree in Pharmaceutical Sciences or relevant discipline.
2. At least twenty (20) years’ experiences in Pharmaceutical Regulatory System and Quality Assurance preferably in academics.
3. Hands-on experience in designing developing and execution of course and work understanding of course implementation
4. Excellent verbal and written communication skills in English.
5. Good interpersonal skills with the ability to lead and approve the course.
6. Working within a quality-focused environment with the ability to deliver against agreed timelines whilst managing workloads and resources to ensure targets are met.
7. Good negotiation skills because their work can involve collaborating with other departments.
8. Analytical skills are needed to review existing procedures, and they also need to have time management skills to meet deadlines and file paperwork on schedule.
9. Demonstrated ability to lead professionals and manage others through influence and collaboration.
10. Demonstrated ability to conduct and interpret quantitative/qualitative information with analytical problem-solving.
11. Proven leadership skills in consulting with demonstrated experience in training and mentoring staff and others.
12. 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, the assignment will be for 15 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.

EVALUATION CRITERIA

1. Past Experience - 35% 
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 (PKR) should be inclusive of all applicable taxes.

Kindly send all Technical and Financial Proposals to ATTN:  USP Pakistan Procurement at [email protected] before the closing date (December, 17^th 2021). When submitting your application, write "Regulatory Sciences Course Consultant" in the email Subject Line.