Washington, DC – July 2023. In the context of the meeting of the National Regulatory Authorities of Regional Reference (NRAr) Group, the Department of Innovation and Access to Medicines and Health Technologies (IMT) at PAHO presented the progress of the learning itinerary project known as REGTEC, which is specifically designed for professionals that work in national regulatory systems.
The itinerary, which will be hosted on PAHO's Virtual Campus for Public Health (VCPH), aims at professionals who perform regulatory functions and activities to guide and supplement, as necessary, the training plans and efforts developed in the professional sphere and in their institutions. It seeks to contribute effectively to the continuous training of human resources involved in the regulation of medicines and other health technologies to promote capacity building and good regulatory practices.
In line with the mandates of PAHO Member States for the strengthening and continuous improvement of regulatory systems, and the recommendations of the Pan American Network for Drug Regulatory Harmonization (PANDRH) on competency-based professional training models, the learning itinerary focuses on the distinctive challenges and priorities of medical products regulation within the Region. Furthermore, it addresses the potential role of regulatory systems in fostering health technology production and effective responses to health emergencies. Additionally, REGTEC places special emphasis on regulators from nations with structural challenges or limited regulatory capacities.
A learning itinerary provides for the development of key competences defined for a specific professional field through a range of tailored learning activities, including courses, workshops, seminars, and communities of practice. It is designed to be flexible and comprehensive, accommodating mandatory, optional, and complementary training.
During this meeting, a standout on REGTEC's launch is the need to revamp and update the virtual course “Health Regulation of Biological and Biotechnological Products.” This course not only responds to the current priorities in the Region of the Americas, but it has proven to be very successful in its past two editions with almost 250 participants from 19 countries and continuous requests for reopening.
The NRAr Group expressed support for REGTEC's significance and applauded the progress achieved. The group extended its willingness to contribute to the development and update of thematic modules and contents for the itinerary.
The REGTEC learning itinerary is funded by the Government of Canada as part of its contribution to the PAHO Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and Other Health Technologies in the Americas. This initiative aims to increase the region's capacity to respond more quickly and autonomously to health emergencies and improve access to vaccines, medicines and other medical supplies.
New training spaces, focused on regional policies and needs
The design of the learning itinerary has been based on a comprehensive review of the technical regulatory frameworks to propose a competency-based training model, which integrates knowledge with the tasks, skills, behaviors, and attitudes necessary for the performance of regulatory activities. In addition, it contemplates the analysis of the pedagogical guidelines established by UNESCO that focus on lifelong learning, flexibility, inclusion, and the recognition and accreditation of knowledge through micro-credentials, among other criteria.
REGTEC, as a programmatic educational offer, is a proposal that arises from the need for a paradigm shift in response to the multiple demands for the training of human resources of the regulatory authorities of the Americas. The program also aspires to facilitate regulatory systems' maturity by 2030, aligning with the WHO GBT tool's evaluation indicators.
The NRAr Group, with PAHO as its permanent secretariat, met on July 11 and 12 in Washington DC to renew its commitments in the context of the Policy for the Strengthening of National Regulatory Systems for Medicines and Other Health Technologies and have a joint plan of action; among other objectives.