Learning objectives
<br />Introduce the main characteristics of the pharmaceutical world in the new century: changing factors, new concept of health, the drug in the competition and globalization, new stategy for drugs development<br />Explain the basic concept on how a drug is developed, trying to educate the student to the correct and common language used by the different health organizations. Try to transfer the modern approach to the physicians with informations deriving from controlled sources and able to capture their interest<br />Offer a complete picture of the four clinical phases of development a drug in the respect of the actual laws<br />Teach the critical evaluation of the available documentation on a drug according to a well a established score based on good quality criteria<br />Explain the importance of plus value for a product, expecially from the pharmaco-economic point of view<br />What a future Rep needs to know on laws regulating the medical scientific information<br /> <br />Teach the critical evaluation of the available documentation on a drug according to a well established score based on good quality criteria<br />Explain the importance <br />
Course unit content
<br />Agents in health organizations: drug-health-industry<br />New frontiers in the pharmaceutical research<br />Which kind of informations do the physicians need? Which phisician consider fundamental and from where do they derive? How is determined its value?<br />The pharmaceutical scenario in the new century. The competition areas, changing factors and evaluation of the communication<br />Drug: definition and values<br />New concept of Health<br />Relationship between Scientific research and Marketing (theory of needs, different marketing approaches, the story of a drug: from birth to death)<br />The pharmacological research: from the idea to the product. Drug discovery, technological revolution<br />The pre-clinical development: objectives,pharma-toxicology, limits of experiments in animals<br />The clinical development: Phse I, II, III, IV. Aims, eperimental designs, sample size, experimental centres selection<br />The protocol, CRF, monitoring, experimental design, principal statistical concepts<br />Structures and rules responsible for ethical approach to clinical research, GCP procedure<br />Basics of pharmacokinetic<br />Sponsor's and Investigator's responsabilities during a clinical study<br />Drug dossier submission and product on the market<br />Basic pharmaco-economic evaluations. Disease Management<br />Laws and rules to be followed in the medical information, deontological relationship betwen Rep and physician<br />Basic concepts on adverse events<br />Evaluation of documents for medical information: origins, quality criteria. Possible matters to use new drugs<br />National/Regional and International, therapeutic compendium, assistence to prescription, control systems of prescription<br /> <br /> <br /> <br /> <br /> <br /> <br />
Bibliography
<br />Aldo Bertelli : Farmacologia Clinica e Terapia. C. G. Edizioni Medico Scientifiche - Torino<br />Pocock S. J. Clinical Trials: Design, conduct and analysis. New York - Oxford University Press 1986<br />Moher D. Schultz K. F., Altman D.: The Consort statement: revised recommendations for improving the quality of reports or parallel group trials. Lancet 2001: 357; 1191-1194<br />Piantadosi S. Clinical Trials: A methodologic prospective. New York - John Willey and sons 2002
