Innova Salutem | International Public Heath Protection Initiative for Nicaragua and Latin America

International Public Health Protection Initiative for Nicaragua and Latin America

General Objective

Ensuring the quality of health services in a comprehensive and integrated way through the production and certification of biological medicines and health technology manufacturing for domestic and international development.

Core Competences

Create in Nicaragua a comprehensive system for training highly qualified personnel for high technologies industry.

Technology transfer

Transfer of proven production technologies for immunobiologicals prepared.

Quality assurance

Precise certification and quality control exercised by international organisations at all stages.

Specific Objectives

Strengthen the production capacity and regulation of health technologies

Strengthen the National Regulatory Authority of drugs and biologicals of Nicaragua.

Share experiences and skills with the countries of Central America and Latin America to promote health technology transfer, set in the South-South cooperation.

Certify the plant and production of biological drugs.

Improve manufacturing processes for health technology.

Strategy

The creation of a biotechnology plant in Nicaragua is the first project developed by INNOVA Salutem, which includes the transfer of health technologies with the St. Petersburg's Scientific Research Institute of Vaccines and Sera, Russia.

To Nicaragua and Latin America it represents a great opportunity, because it will have the supply of quality vaccines at affordable prices, ensuring the minimum period for delivery of supplies abroad. Nicaragua will be a platform for technology transfer and innovation, because the capacity of qualified personnel efficiently ensure a quick implementation of these programs.

Core Competences

The production of biological drugs requires the formation of highly qualified human resources as: microbiologists, virologists specialist in drug surveillance etc. which are capable of ensuring medical supplies with quality, safety and efficacy for the welfare of the population, which must be based on evidence of Good Manufacturing Practices. For the training of human resources, there have been identified forming academic communities in the field of health programs that provide comprehensive specialized higher education.

Academic and lab. programs

Establishing partnerships with universities that have intellectual and technological leadership in health sciences at national and international level such as the National Autonomous University of Managua and Leon, National University of Engineering, ISALUD and Chemical Pharmaceutical Academy of St. Petersburg; aiming to provide training, retraining and training of human resources.

Pilot training

Academic and community health professionals ensure by tests the efficient production of biological and drugs for the prevention of diseases, with the support of productive institutions certifying the expertise.

Technology transfer

First Stage

At the end of 2016 and beginning of 2017, there will be an infrastructure equipped with communication equipment and production lines to manufacture influenza vaccine, where Russia will supply antigens.

Second Stage

During the implementation of stage I, the National Regulatory Authority, of third level, will be created, which allows to pass the entire production cycle. By 2019 it is planned to start in Nicaragua the production of antigens for vaccine production and thus the production of biological will be completely taken.

Quality assurance

For the construction of the biological production plant in Nicaragua and in order to maintain quality standards in compliance with national and international standards, it is necessary that the Pan American Health Organization / World Health Organization (PAHO / WHO) and international institutions as CECMED of Cuba, certify its construction and production thereof. Which must ensure that national health technology manufacturing is in accordance to compliance with good manufacturing practice and laboratory.

Certification of production plants

The Russian plant SpbNIIVS and the biotechnology plant in Nicaragua must be certified by the competent international bodies.

Product registration

Implementation of plans consistent with the health technologies to be made, with the corresponding situation analysis and cost-benefit to the health system.

Strengthening of the National Regulatory Authority

Advice and provide technical support to the National Drug Regulatory Authority on regulatory aspects and monitoring of product quality consistent with PAHO / WHO standards.