The benchmarking exercise represents one of the main components of the five-step capacity building model developed by WHO RSS team to help ensure access to safe, effective and quality medical products, by assisting countries reach and sustain a level of regulatory oversight that is effective, efficient and transparent.
This course is meant to enhance the quality of benchmarking outputs by providing the basis of harmonizing approaches among assessors using the GBT (Global Benchmarking Tool) to benchmark regulatory authorities.
Language: English
Not disease specific
Course information
Course overview: This training is developed for WHO assessors using the Global Benchmarking Tool (GBT) to benchmark Regulatory Authorities. In line with numerous inputs received during the development process of the GBT on the need of enhancing the benchmarking process in terms of consistency and reliability, the WHO Regulatory System Strengthening (RSS) team developed a number of documents and mechanisms, aimed at enabling the harmonization of approaches and the reliability of benchmarking outcomes.
Among these mechanisms, which include i) criteria for selecting assessors, ii) theoretical and “on the job” training on the benchmarking process, iii) mechanisms for the evaluation of assessor performance towards their qualification/disqualification, the present course focuses exclusively on the theoretical training program of already selected assessors.
The qualifications and competencies (education, knowledge, skills and behavior) of GBT assessors are evaluated before involving them in any benchmarking-related activity, to ensure high-quality output from the assessment team, but initial as well as continuous training is necessary to maintain and enhance assessors’ competence in performing their assignments during GBT benchmarking missions.
The course is targeted to all GBT assessors, independently on their qualification status (experienced/beginner), who are requested to attend this training before being involved in benchmarking related activities.
The aforementioned qualification scheme along with the training program will allow the identification, maintenance and update of a roster of qualified international experts eligible for assessing regulatory systems.
Course Duration: Approximately 3.5 hours.
Certificate: A Certificate of Achievement will be issued to participants who score at least 80% of the total points available in the final assessment. Participants who receive a certificate of achievement can also download an Open Badge for this course. Click here to learn how.
What you'll learn
- Contextualise the WHO benchmarking activities
- Describe the Regulatory Systems Strengthening programme and its key activities
- Acknowledge the benchmarking process and its steps
- Review the structure of the Global Benchmarking Tool
- Interpret the scoring system and apply it accurately
- Use the computerised GBT effectively
- Perform root cause analysis by applying the general principles of risk-based approach
- Draft effective reports and present results
- Explain the importance of enhancing soft skills to manage benchmarking activities, and conduct interviews
Course contents
Module 0: Introduction to the course:
Introductory module that gives an overview of the context and historical elements that brought to the construction of the course.Module 1: Introduction to WHO Regulatory Systems Strengthening (RSS) programme:
At the end of this module, you will: Describe the context of the WHO RSS programme. Recall the history of the WHO Global Benchmarking Tool and its predecessor tools. Define the four maturity levels used by GBT to assess a regulatory system. Acknowledge the WHO Coalition of Interested Parties initiative and the WHO Listed Authorities framework.Module 2: Global Benchmarking Tool: Structure and fact sheet:
At the end of the module, you will: Define regulatory systems. Acknowledge how good regulatory practices are embedded in the Global Benchmarking Tool. Outline the structure of the Global Benchmarking Tool. List its indicators and sub-indicators and Utilise the content of the fact sheets, which are an integral part of the benchmarking tool.Module 3: Scoring System and Maturity Level Algorithm:
At the end of the module, you will: Describe the concept of maturity levels and how it is integrated into the GBT, and examine the algorithm to measure Maturity Level.Module 4: Assessors Database, Computerised GBT and Other Electronic Platforms:
At the end of the module, you will: Acknowledge the assessors database and the evaluation and monitoring program for assessors, acknowledge the NRA's database, operate the computerised Global Benchmarking Tool, and navigate the SharePoint.Module 5: Benchmarking Process and Methodology:
At the end of this module, you will: Acknowledge the steps of the benchmarking process; Explain the benchmarking methodology, along with its complementary activities, such as the observed audits and vigilance field visits; Manage the preparatory activities necessary for a successful benchmarking missionModule 6: Evidence-Based Benchmarking:
At the end of this module, you will: Identify inputs and outputs of the benchmarking process. Acknowledge evidence-based benchmarking and its importance. Manage how to sample and look into evidence. Explain how root cause analysis is performed to identify the factors causing poor performance of regulatory functions. Apply the good practices of collecting and using documenting evidence.Module 7A: Effective Report Preparation and IDP Formulation:
At the end of this module, you will: Acknowledge the value of a good benchmarking report. Prepare effective assessors’ inputs. Assign correct scoring, and identify the level of detail required according to the results.Module 7B: Effective Report Writing and IDP Formulation: Strengths, Recommendations and Executive Summary:
At the end of this module, you will: Build effective IDPs. Describe the strengths of regulatory functions. Prepare a coherent executive summary and recall how to generate the benchmarking report.Module 8: Good Benchmarking Practices:
At the end of this module, you will: Communicate properly during a benchmarking exercise. Acknowledge the types and styles of communication. Manage different techniques for asking questions and listening to answers during interviewsFinal Assessment
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Certificate Requirements
- Gain a Record of Achievement by earning at least 80% of the maximum number of points from all graded assignments.