Clinical Experimentation: Regulation, Management and Operations

Students learn the theoretical, practical and ethical issues surrounding the important role in conducting Clinical Trials. Starting with acquiring a deep understanding and appreciation of methodologies used in pharmaceutical clinical research, students will learn how to: design study protocols, enroll appropriate candidates for trials, evaluate results and acceptable tolerances in treatments, and weigh ethical considerations concerning their work.

Students will gain important insight into the most current hot topics in the field of research and will discern the myriad ways in which laws and regulations governing clinical trials and research are changing and affecting research realms, from regulation over the ways studies are carried out to cutting edge practices in research methodologies.

The program allows students to:

• Gain knowledge on the latest norms and regulations governing Clinical Trials, especially Italian GCP norms and inspections as carried out by the AIF - Italian Pharmaceutical Agency.
• Properly define best practices in Clinical Trial methodology from planning, study design, financial analysis and programming cost outlays.
• Determine proper patient/candidate agreements for participating in Clinical Trials, from all necessary documentation and waivers to insurance and legal aspects and fully understand the role of an Independent Ethical Board.
• Understand and various roles involved in Clinical Trials, from Trial Coordinator and Data Management, to Handler of biological specimens and adopt specific ICT techniques for conducting and monitoring Clinical Trials.
• Learn skills for evaluating Clinical Trial results, employing various analysis models and economic models for managing financial aspects of Clinical Trials.
• Gain a broad perspective across the industry as a whole and the role of healthcare companies in the promotion and management of Clinical Trials, especially as related to the Scientific Role and Management of studies within an organization.

The programme is taught in Italian. 

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