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EBM Basic Course (EBM-P)
EBM Basic Course is the first step towards using and developing of guidelines and standards of management, formularies, systematic reviews and HTA (Health Technology Assessment) reports.
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EBM Basic Course (EBM-P) framework program
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Introduction to EBM and EBHC
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Models and study designs in medicine
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Interpretation of results – values: α, p, CI, RR, RRR, OR, ARR, NNT
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Clinical trials – evaluation of credibility. Clinical and statistical significance
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Analysis of credibility: prognosis
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Measures of diagnostic accuracy
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Analysis of credibility: diagnostics
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Analysis of credibility: harmful agents
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Analysis of credibility: treatments
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Systematic and non-systematic reviews, meta-analyses, software
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Medical databases – search of relevant literature
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Search strategies
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HTA - introduction
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Info
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EBM Advanced Course (EBM-Z)
The course is intended for individuals who wish to extend their knowledge. While the Basic Course is oriented to dissemination of knowledge, the aim of the Advanced Course is to teach practical skills, as indicated by proportionally longer time spent on practical exercises.
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EBM Advanced Course (EBM-Z) framework program
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EBM – introduction/reminder
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Medical statistics (RR, RRR, OR, NNT, WMD, p, α, β, survival curves), compilation of the results of clinical trials
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Clinical and statistical significance
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Evaluation of clinical trials: treatment
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Homogeneity and heterogeneity of studies
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Evaluation of clinical trials: diagnostics
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Guidelines for Health Technology Assessment (AHTA-Pol)
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Evaluation and interpretation of selected systematic reviews concerning diagnostics and treatment
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Guidelines and standards of management
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Info
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HTA Basic Course (HTA-P)
Participants of the course will be instructed in methodology of development of systematic reviews, basic principles of cost analysis and methods of application of clinical and cost data in development of economic analyses. The course consists mostly of lectures and presentations of selected solutions.
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HTA Basic Course (HTA-P) framework program
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HTA – introduction
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Guidelines for Health Technology Assessment (AHTA-Pol)
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Cost analysis: types, credibility criteria, study types
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Cost-effectiveness analysis: types, credibility criteria, tools
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Cost-utility analysis
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Discounting of costs and effects
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Sensitivity analysis in economic analyses; software
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Reimbursement and benefit packages
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EBHC – introduction
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Info
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HTA Advanced Course (HTA-Z)
The course is intended for individuals knowledgeable about basic principles of HTA and wishing to extend their knowledge, learn how to use the results of economic analyses and how to develop credible economic analyses and HTA reports. Participants of the course will also receive basic information concerning modeling and function of the most important institutions dealing with Health Technology Assessment worldwide.
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HTA Advanced Course (HTA-Z) framework program
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HTA and EBM – introduction/reminder
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Cost assessment and registries in HTA. Principles and methods of cost data collection
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Critical appraisal of economic analyses
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Budget impact analysis: introduction
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Budget impact analysis: design
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Modeling in HTA analyses
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HTA reports – credibility and transparency criteria developed by the INAHTA
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Design of a complete HTA report
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The guaranteed benefit package – rules of placing of healthcare services
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Principles of creation of the guaranteed benefit package
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Methods of pricing. Use of HTA reports in pricing
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Groups with a common limit. How it is done elsewhere?
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Info
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Medical Databases Course (BIM)
The course was inspired by former participants of the EBM and HTA courses, who – armed with analytical tools – encountered problems in finding of appropriate data in the world-wide resources of the internet. Search and selection of medical and economical information requires ability to use computerized databases, knowledge of the principles of use of various search engines and ability to formulate clinical questions and build search strategies.
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Medical Databases Course (BIM) framework program
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Role of EBM in development of pharmacoeconomic analyses and HTA reports
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Sources of medical literature.
Computerized medical and economical databases
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Formulating of clinical questions
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Principles of use of the MEDLINE database
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Searching in MEDLINE
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Principles of use of the Cochrane Library
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Searching in the Cochrane Library
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Sources of secondary studies
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Searching for secondary studies
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Medical libraries
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Info
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ICH GCP Practical Course (GCP)
The aim of this course is to make participants acquainted with practical aspects of Good Clinical Practice – ethical and scientific standards in conduction of clinical trials. The course is intended for individuals who conduct or plan to conduct clinical trials and wish to extend their knowledge about practical aspects of GCP. The course may be an excellent introduction for persons who plan or begin to work for Contract Research Organizations (CRO). The course is aimed at gaining of practical skills related to conduction of clinical trials according to the principles of GCP.
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ICH BCP Practical Course (GCP) framework program
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Declaration of Helsinki
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Essential terminology
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Basic principles of GCP
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Informed Consent Form and guidelines concerning informed consent
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Clinical trial documentation (the Study Protocol, the Investigator’s Brochure, the CRF)
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Organization of the Investigator Site File (ISF)
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Investigational Medicinal Product (IMP) – quantitative conformity, compliance and relabeling
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Safety in clinical trials – reporting of AEs and SAEs
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Safety in clinical trials – reporting of AEs and SAEs
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Organization of a clinical trial – practical aspects
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Info
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