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Learning outcomes

Precision medicine: develop skills for projecting and applying pharmacological therapy/ies according to concepts of appropriateness and efficacy by combining the relevant information about the drug/s with the characteristics of the individual patients, the context where the disease develops and is treated. The student will be exposed to the principles governing drug validation: EBM, the principles of information and relevance of scientific data and their validity, clinical studies, ethic commeettees, consulting data banks for clinical studies.
Analysis of vaccine and drug development for treatment of COVID-19 nfection
EMB in practice: the real-world medicine
Learn to use models of PK and pharmacogenetics to maximize benefits and reduce ADRs in individual patients
Understand significance, limits and advantages produced by post-marketing followup of drugs (i.e. pharmacosurveillance) also by knowing the methodologies and the practical aspects of these processes.
Become aware of application of new biotechnologies for treatments of diseases, including cell therapies.

Program

1- Precision medicine: definition
Evidence-based medicine: significance and evolution to Real World Evidence
Practical significance of Evidence-based medicine: classification of evidences, how are they generated and organization of a clinical trial: from case report to randomized trials. The authorities monitoring and governing drug use in therapies.
Principles of experimental drug research
New aspects of drug development: ethics and patient involvement, significance of PK and pharmacogenomics for individualization and appropriateness of therapy .
2- Postmarketing followup of drugs: the “how”, the sources and the methodologies of informations, the data bases of drug surveillance
3- PK: advanced use of PK principles for therapy adaptation to patient and disease
4- Biotechnology: generation, use and administrative aspects of biotechnology drugs, including cells.

Examination Methods