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