Clinical Research Development and Management

Course ID
6 CFU (3+3)

Aims: Knowledge of new drug development and concerning regulations

The Course is organized into two modules

Clinical Research Development

Teacher: Giuseppe Assogna

Program: Outline of Pharmacoeconomics.Price and Reimbursement (EU and Italian systems). From registration to drug availability: main steps and main stakeholders involved. Generics and Biosimilars. Italian law on scientific information (notes on Farmindustria code)

Clinical Research Management

Teacher: Giovan Battista Leproux

Program: Clinical development . Focus on the transition from pre-clinical to clinical development. Clinical protocol organization. Pharmacovigilance and relative Italian and EU rules. Ethics in Clinical Research. Pharma Company organization and main roles and activities within a Medical Department . Work organization: from hierarchical to lean organization

Suggested textbooks: Materials provided by the teachers

Course Downloads:

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