Vision
A vision was developed for the capacity building mechanism in SEARN. It is summarized and further described below:
The following key components are foreseen:
- At the center of the system is a platform, based on the Global Competency Framework, complemented by additional information (e.g. NRA goals), which together form the SEARN competency framework.
- NRAs may use this platform or an associated system as a learning management system to help them identify their competency needs, resources and gaps based on their goals, and plan/budget their trainings accordingly
- NRA staff may use this platform to identify their individual competency needs and gaps based on their personal goals and the goals of their NRA, access resources, and document their competencies in their regulatory passport.
- Training providers, including regional centers of excellence, partners, WHO and others, may use this platform to provide an update information about their resources against the SEARN competency framework.
- SEARN WG2 is responsible of listing and reviewing training providers, and would also constitute a pool of trainers which can be used as resources by training providers.
NRA goals
For the purpose of this strategy, the SEARN Members agreed on 3 NRA goals for medicines and vaccines. For each NRA goal, a basic algorithm was developed to link activities and goals as follows:
This basic algorithm was complemented by a review from the secretariat and a written consultation to WG1, WG2 and WG3 to ensure there was agreement on the classification of the activities according to the NRA goal.
Regional Centres of Regulatory Excellence (RCOE)
A survey was conducted in 2023-2024 to identify potential regional centers of regulatory excellence (RCOEs), which was identified as a core component for this strategy. An RCOE could be either an NRA or and academic institutions.
Highlights:
- Potential RCOEs, either NRA or from other institutions have been identified in all selected domains
- While several institutions were identified for pharmacovigilance and laboratories, only one institution was identified at this stage for Marketing Authorizations for Pharmaceuticals and Regulatory Quality Management Systems
- Limited academic institutions were identified, suggesting further outreach efforts could be made.
The establishment of RCOEs was piloted within the domain of Regulatory Quality Management System (QMS). Contacts were made with Bhutan which had expressed interest in this field during the 2023-2024 survey. Bhutan confirmed interest and indicated that the RCOE would be based on a collaboration between the BFDA and the Khesar Gyalpo University of Medical Sciences of Bhutan.
The discussions with both institution enabled to further refine the proposed collaboration model for establishing RCOEs:
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To support the development of the SEARN Network of RCOEs, a concept note was developed to facilitate initial discussions between NRAs and universities
To address situations when several potential RCOEs have been identified a selection process was adopted by the Steering group to collect information as per different criteria (scope, capacity, experience, infrastructure and equipment) to select the most promising expressions of interest (EOI).
After running the selection process when applicable, the list of RCOEs in domains prioritized by SEARN Working groups was finalized.
To further support the establishment and running of the network of RCOEs, terms of reference have also been developed for SEARN RCOEs, including definitions, core principles, governance and institutional arrangements, roles and responsibilities, collaboration with SEARN Secretariat and between RCOEs, engagement beyond NRAs, conflict of interest management, quality assurance, and continuous improvement.
The SEARN RCOEs will provide updates at each meeting of the relevant SEARN Working Group and submit before each meeting of the SEARN Assembly an annual workplan, activity report, and performance and outcome indicators.
Developing a sustainable and impactful in-person training programme: the GSDP pilot
While it is expected that many of the activities can be organized at limited costs and virtually, some domains require in person trainings. As such, it was felt critical to develop a sustainable model for in-person trainings. Among different domains, the following activities were identified as being particularly concerned by the need for in-person trainings: inspections for good pharmacy practices (GPP), good storage and distribution practices (GSDP), good manufacturing practices (GMP), and testing by national quality control laboratories (NQCLs).
In this context, the Assembly requested to pilot the development and implementation of a pilot regional programme of in-country GSDP workshops. Indeed, compliance with GSDP is essential to ensure only genuine medical products are sold to patients, and to maintain their quality from lot release to dispensation (e.g. protect them from temperature, dust, light and humidity).
Following simulations, it quickly appeared that regional workshops would not be cost-effective nor impactful, as countries would require several hundreds of staff to be trained. To address this need, it was rather proposed to develop a programme of in-country workshops, where facilitators would travel rather than participants. A survey was conducted among SEARN members to refine estimations. The survey confirmed that several hundreds of staff would require training with GSDP, and all responding SEARN members confirmed their intention to participate in the SEARN in-country GSDP workshop programme.
In close collaboration with Australia TGA (Therapeutic Goods Administration), CEPI (Coalition for Epidemic Preparedness Innovations), QUAMED (Quality Medicines for All), UNICEF, USP (United-States Pharmacopoeia) PQM+ (Promoting the Quality of Medicine Plus +) and WHO, SEARN has developed a comprehensive training programme combining:
- Online self-paced trainings from QUAMED and UNICEF
- A regular regional virtual workshop, to cover other knowledge-based modules which can be covered virtually,
- In-country in-person workshops, focused mainly on practice and implementation of the gained knowledge.
A first batch of 4 GSDP inspectors from Maldives and 5 GSDP inspectors from Bangladesh participated in this pilot SEARN in-country GSDP workshop organised in Male, Madives, from 14 to 16 December 2025. The pilot workshop was supported by QUAMED and 2 experienced GSDP auditors and facilitators. The first day was dedicated to Q&A on past training modules, presentation/role play on skills and behaviour expected from inspector, and planning of a coached inspection. Day 2 and morning Day 3 were dedicated to conducting a coached inspection of 2 voluntary wholesalers, each team supported by one facilitator. Day 3 afternoon was allocated to initiating inspection reports and presenting to the group.
The pilot enabled to develop all materials required to run the workshop (presentations, facilitators guides, archiving of documents, list of participants, evaluation of the workshop etc.). While there was high satisfaction expressed by participants and the proof of concept could be established, the pilot was rich in learnings and feedback from facilitators and participants, leading to further improvements of the training materials. A process was also agreed to facilitate participation of NRAs in the SEARN GSDP training programme.
The programme is now ready to take off and a pool of trainers from NRAs will be gradually developed while workshops are conducted in the SEARN countries. CEPI generously provided funds to support the first workshops.
The content, including the template report, will continue to be updated based on experience and in coordination with the RCOE GSDP.
Competency framework to ensure Safe medicines during pregnancy
In line with the theme of the Assembly meeting held in Dhaka, Bangladesh in July 2024, on ‘Safe medicines during pregnancy’, SEARN Members decided the development of a competency framework to support NRAs in ensuring safe medicines during pregnancy. The targeted profiles from the global competency framework are ‘Reviewers’ and ‘Vigilance personnel’.
The aim of this additional SEARN domain in the competency framework is to address what is specific to pregnancy and may be missing from trainings pertaining to activities identified in the global competency framework, without being redundant with other activities identified by the Global and SEARN competency frameworks.
As per other domains of the SEARN competency framework, it will be included in the future capacity building platform to facilitate identifying training opportunities and gaps.