Teacher: Luigi Godi
Aims: to know the reference legislation and the operating procedures of a CRO as a structure involved in the management of a pre-clinical or clinical trial relevant to a drug or a medical device
Program: 1) The Contract Research Organization (definition, activity, outsourcing, intelligence, market and its prospects, etc)
2) CRO decree (illustration of the decree)
3) Responsibilities of the CROs in clinical trials of a medicinal product or medical device
4) Preparation of a quotation (practical exercise using a clinical study draft, assuming the necessary assumptions and calculating a quotation)
5) Preparation of a Business Plan
6) Training and education activities (programming, participation, course certification, trainer qualification, self-learning verification)
7) Performance Review and career development
