Ateneo - UPO

For the public health section, the course will be organized around the reading of articles reporting original research. In each class, one article will be read and the following will be discussed: methodological aspects, results, the impact that the results may have in practice. The course of statistics consists in a first part with topics related to descriptive statistics and in a second part that will concern the inferential statistics. In Innovation and Patents part specific topics include: Good Manufacturing Practice (GMP) procedures and the applicable regulatory framework; differences and similarities between GMP facilities, cell factories, clean rooms, and the laws governing their activities; therapeutic procedures requiring a GMP facility; the Technical Director of a GMP facility and his or characteristics; innovative processes leading to drug development (GCP); the design and phases of clinical trials for n certification/accreditation of diagnostic laboratories and procedures for developing a diagnostic kit; internal and external quality controls; general criteria and applicable legislation for patent procedures; biobanking and the preservation of biological samples; and informed consent.

Statistics: W.W. Daniel, CL. Cross Biostatistics, Tenth edition. John Wiley & Sons Rosner B. Fundamentals of Biostatistics. Eighth edition. Brooks/Cole Pub Co Public health and Innovation and Patents: There are no reference texts: the articles that will be read, and the slides displayed, they will be available in the DIR platform

The course aims to: provide methodological issues related to descriptive and inferential statistics, select the appropriate statistical method to summarize study data, interpretation of the results. - Know the main concepts of health, promotion and prevention of diseases in public health - use scientific literature in order to obtain useful information understanding the complexity of patients' health problems e the organizational problems of the service in which they operate; - participate in scientific research, actively intervening both in phase of development of the study protocol and interpretation of the results.
Learn the basics of regulation and the activities of a state-of-the-art laboratory with regards to diagnostics, research and the production of cellular products for clinical use (GMP-grade products).

Basic knowledge in mathematics. Basics of hygiene and epidemiology

Lectures, Classroom exercises. Reading of scientific articles, individually or in groups, and discussion e interpretation of the results.

The Course material is available in the Moodle platform. Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The examination will be written. A scientific article will be provided and the exam will consist of 10 multiple-choice questions for the Public Health section, as well as exercises and open-ended questions for the Statistics section. For the Innovation and Patents section, the exam will include 10 multiple-choice questions. Each exercise or question will be assigned a specific score, which will contribute to the calculation of the final grade.

The frequency distribution. Measures of Central Tendency and dispersion. Properties of Probability. Probability distribution: the Poisson and normal distribution. Sampling distribution. Distribution of the sample mean. Confidence interval. Hypothesis testing: a single population mean, the difference between two population means, a single population proportion. Type I and type II error and the power of a test. Chi-square test. Odds ratio. The correlation coefficient and the regression model. Survival analysis. Health concept -Promotion and prevention Determinants and risk factors Tools for measuring health -Epidemiology - frequency measurements - association measures - bias, confounding Critical reading of a scientific article and in particular: - identification of the knowledge on which the work is based; - hypotheses and objectives of the research; - recognition of the research design - transversal - cohort - case-control – experimental.
Students will learn the basics of applying Good Manufacturing Practice (GMP) procedures and the relevant regulatory framework; differences and similarities between GMP facilities, cell factories, clean rooms, etc., and the legislation governing their activities; therapeutic procedures requiring a GMP facility; the Technical Director of a GMP facility and his or her characteristics; innovative processes leading to drug development (GCP); the design and phases of clinical trials for new certification/accreditation of diagnostic laboratories and procedures for developing a diagnostic kit; internal and external quality controls; general criteria and relevant legislation for patent procedures; biobanking and the preservation of biological samples; and informed consent.

Knowledge and understanding: to go in depth of statistical methods for the analysis of clinical data; use scientific literature in order to obtain useful information understanding the complexity of patients' health problems e the organizational problems of the service in which they operate.
Students will learn the basics of applying Good Manufacturing Practice (GMP) procedures and the relevant regulatory framework; differences and similarities between GMP facilities, cell factories, clean rooms, etc., and the legislation governing their activities; therapeutic procedures requiring a GMP facility; the Technical Director of a GMP facility and his or her characteristics; innovative processes leading to drug development (GCP); the design and phases of clinical trials for new certification/accreditation of diagnostic laboratories and procedures for developing a diagnostic kit; internal and external quality controls; general criteria and relevant legislation for patent procedures; biobanking and the preservation of biological samples; and informed consent.
Ability to apply knowledge and understanding: translating theory into practice by concretely working at the solutions to exercises; participate in scientific research, actively intervening both in phase of development of the study protocol and interpretation of the results. Decision-making autonomy: acquiring autonomy in decision to conduct the analysis of data obtained from surveys. Communication skills: ability to communicate knowledge with clarity, scientific and methodological rigour. Learning skills: dealing with the information obtained from clinical and epidemiological studies with the objective of collecting and organizing data and correctly interpreting the information.