Management Sciences for Health
Management Sciences for Health (MSH), a global health nonprofit organization, uses proven approaches developed over 40 years to help leaders, health managers, and communities in developing nations build stronger health systems for greater health impact. We work to save lives by closing the gap between knowledge and action in public health. Since its founding in 1971, MSH has worked in…
Statement of Work
Date: December 20, 2021
(Only for Nepalese Nationals)
Project name: USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program
Title: Consultant – Clinical Trials
Estimated Period of Performance: January 15, 2022 to October 30, 2022, Total LOE: 120 days
Introduction and Background:
Funded by the U.S. Agency for International Development (USAID), the Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, implemented by Management Sciences for Health, provides pharmaceutical system strengthening assistance for sustained improvements in health system performance and to advance USAID’s goals of preventing child and maternal deaths, controlling the HIV/AIDS epidemic, and combating infectious disease threats, as well as expanding essential health coverage.
The goal of the global, five-year (2018–2023) program is to enable low- and middle-income countries to strengthen their pharmaceutical systems to ensure sustainable access to and appropriate use of safe, effective, quality-assured, and affordable essential medicines and medicine-related pharmaceutical services. To achieve this goal, the MTAPS program has the following objectives:
The purpose of MTaPS is to provide pharmaceutical system strengthening assistance for sustained improvements in health system performance, and to advance USAID’s goals of Preventing Child and Maternal Deaths, Controlling the HIV/AIDS Epidemic, and Combatting Infectious Disease Threats, as well as expanding essential health coverage.
The recent WHO Global Benchmarking Tool (GBT) assessment identified the regulatory maturity level of Nepal’s regulatory agency—the Department of Drug Administration (DDA)—as low. Several measures are needed to increase the regulatory maturity of the DDA and advance the government’s goals for the pharmaceutical sector, including the regulation of clinical trials (CT).
MTaPS Nepal is supporting the Ministry of Health and Population (MoHP)/DDA to strengthen its regulatory maturity level. An action plan for the years 2021-2023 was drafted based on the DDA Business Plan 2019-2020, the WHO GBT assessment conducted in April-May 2021 and the accompanying Institutional Development Plan (IDP).
The DDA and National Medicines Laboratory (NML) maturity level action plan (MALAP) 2021-2023 reflects the steps towards attainment of Maturity Level (ML) 2 in the first year from July 2021 to July 2022 and targeting ML 3 in the second year from August 2022 to July 2023 according to WHO GBT and based on the road map developed to achieve this goal. The action plan covers all regulatory areas including CT for which activities to be implemented have been detailed.
The objective of this consultancy is to assist the DDA to implement recommended activities from the MALAP in the areas of CT towards attaining maturity level 3.
Description of services to be provided
The consultant will support MTaPS in collaborating with the DDA to:
The consultant will undertake the following activities in collaboration with DDA and MTaPS team:
The interested candidate possessing above qualification and experiences are requested to apply with the following details at firstname.lastname@example.org