Strengthening Human Resources Capacity of National Medicines Regulatory Authorities by establishing state-of-the-art learning systems, Digital Centres of Excellence and Training Academies.
ENHANCING REGULATORY WORKFORCE TALENT—a SUSTAINABLE APPROACH TO ML3 AND WLA status
National Medicines Regulatory Authorities (NMRAs) play a pivotal role in ensuring access to safe and effective medical products, including medicines, medical devices, and diagnostics.
A competent workforce is one of the foundational components for the NMRAs to operate effectively. Therefore, systematic and continuous regulatory workforce development is critical to addressing the gaps in regulatory capacity for medical products. The WHO Global Competency Framework for regulators of medicines offers a roadmap for harmonizing workforce development efforts by establishing an internationally accepted set of best practice competencies.
Working with an array of partners and leveraging state-of-the-art digital learning technologies, Empower School of Health offers a wide range of solutions to effectively implement the Framework. By applying evidence-based learning approaches and continuously integrating the latest open-source digital tools and AI systems, Empower, works with Ministries of Health to build comprehensive, cost-effective and impactful training solutions. Specifically:
- We develop digital competency assessments and mapping that not only serve as a baseline but also provide ongoing insight as the training progresses
- We design digital learning management systems for Ministries of Health, and build centres for digital learning to deliver and measure the impact of training
- We develop and curate tailored courses (in 16 languages) and build and sustain communities-of-practice solutions to sustain continuous professional development
- We offer consultancy services to support setting up regulatory training academies that can operate sustainably under the purview of the Department of Human Resources and Talent Management.
The framework for establishing a Centre of Excellence (COE) for NMRA workforce strengthening has 4 foundational elements and 7 key steps.
The 4
foundational elements include:
- NMRA's vision, strategy, and goals: Understanding the country’s vision, goals and timeline.
- Organizational fit: Support in setting up divisions for capacity building (& capable teams) under NMRAs for sustainability measures.
- Alignment with the Department of Finance and Budgeting: Activities will require human, financial and technology-related resources to achieve their goals.
- Alignment with the Department of Information Technology: Training & skilling deployment through digital technologies while pre-assessing the desired hardware, software & connectivity.
The 7 steps to establishing a Centre of Excellence for workforce strengthening:
- Identify the target audience: Segmentation of four main NMRA cadres, in terms of tenure, seniority, learning styles, etc. will be assessed.
- Conduct needs assessment and workforce competency assessment: Developing a Competency Assessment Tool for NMRA based on WHO Global Competency Framework (covering core competencies, meta competencies and core activities)
- Design the curriculum (and digitize the content): Develop a standardized curriculum that covers essential regulatory topics while collaborating with international regulatory bodies, (WHO, USP, etc).
- Design and develop training and skilling methodologies, including a digital learning platform (if required): Empower works with open-source digital learning platforms which are user-friendly, multi-linguistic, highly accessible & designed to support on-the-job upskilling. Training programmes will include hands-on secondments at a more mature NRA.
- Formalize the institutional development plan: to prioritize areas of improvement, based on an assessment carried out through use of WHO’s Global Benchmarking Tool.
- Deliver the trainings (physical and digital) and build a community-of-practice: Roll out the digital learning academy to all NMRA staff, ensuring adequate support and resources are available for successful adoption.
- Measure the outcome and impact: Continuously monitor usage, engagement, and performance to assess the impact and identify areas for improvement
Conclusion: Outcome and Impact
The main outcome of our support is the creation of a competent workforce. We do this by establishing or strengthening the development of a national COE or training academy that can reliably deliver quality-assured and certified training to its workforce.
Other outcomes include increased cross-border collaboration and relationship building with regional NRMAs and greater exposure to global best practices in learning, training and skilling.
The ultimate impact will be to improve access to safe, effective and quality-assured medicines.
Our Team
- HE Michele Sidibe Envoy to the African Medicines Agency Senior Advisor and Visionary, Empower School of Health
- Professor Paul Lalvani, Founder and Executive Director, Empower School of Health
- Sakhile Dube-Mwedzi, Coordinator, SADC Medical Products Regulatory Harmonization Programme Senior Advisor and Faculty, Empower School of Health
- Abdelkrim Smine PhD, Former Director of Global Public Health Africa, US Pharmacopeia (USP) Senior Advisor and Faculty, Empower School of Health
- Dr. T S Rao PhD, Former Department of Biotechnology, Govt. of India Senior Advisor, Empower School of Health
- Bruce Lerner, Strategy Management Consultant, Public Health Senior Advisor, Empower School of Health
- Kaushik Desai, Pharmaceutical Manufacturing Expert, Senior Advisor, Empower School of Health
- Dr. Ray Yip, Former head of Gates Foundation in China | Experience in strengthening Africa CDC and building Pharmaceutical Manufacturing Capacity in Africa