The Master aims to form a highly qualified staff, experienced in project management, administration and monitoring of Clinical Trials, by offering both basics and specific knowledge, related to every aspect of the clinical studies’ plan of drugs and medical devices.

Inscriptions are open in October, January, April and July each year. The Course lasts 1 year from the date of inscription and at the end of it a final essay must be discussed in presence.
Lessons will be held via e-learning method: students are provided with handouts, bibliography and self-assessment multiple choice questionnaires. At the end of each class, students must sit the online exam in order to access the following module.

The Master is online, divided in 6 modules with a final exam at the end of each of these. It is mandatory to pass every exam in order to obtain the Master’s Degree.
The modules are:
1. Pathology, Clinical, Pharmacology, Introduction in Clinical Research
2. Clinical Research
3. Regulatory
4. Supervising of Medical Devices, Nutraceutical and Drugs
5. Legal, Insurance and Ethical aspects. The fight against counterfeiting
6. Innovative Therapies: Digital Therapy, Stem Cell, Gene Therapy.
When the student will pass each class and before s/he discusses the final dissertation, s/he will obtain the GCP E6 R2 Certificate.
The Master’ Degree provides 60 CFU, which covers the amount of 1500 hours of learning.

Many opportunities of career are opened to students with this Master’s Degree:
– Graduates in Medicine and Surgery Degree could be offered a job in the management of Clinical Research, which supervises the clinical procedure of drugs; the management of a therapeutic Unit, which in collaboration with the Marketing team follows the evolution of products in different therapeutic areas; Hospital Management, responsible of the activities regarding drugs before and after their consumption and the scientific communication.
– Graduates in Healthcare Profession Degree usually work as Clinical Research Assistant or Monitor career, as supervisor in the monitoring of Clinical Trials.
– Quality Check, as Quality Assurance Manager, who verifies both the quality and the respect of the standard procedure, regulations and laws.
– Safety and Pharmacovigilance Manager, entitled to collect all the active and passive pharmacovigilance alerts.
– Regulatory Affairs Manager, assisted by a team who works on the presentation of the experimentation. The Manager follows the regulatory practices during this experimentation and at the end of the pre-clinical and clinical studies asks for the authorization to take the drug to market.
Other Career opportunities are:
– Scientific Officer of the Ethical Committee, which requires a deep knowledge of the subject that enables the documentation examination to be submitted to the Ethical Committee.
– Clinical trial coordinator at Research’ Hospital and IRCSS.
– Public Hospital, such as ASL or AIFA, as Clinical Trial referent.
– Coordination of renowned ASL Ethical Committee

In order to apply to the Second Level Online Master candidates must have a Master’s Degree in scientific, economic or legal disciplines.

The tuition cost is 2.500 €, to be paid in 4 installments.

At least 40 participants will be required in order to activate the Master. Once the necessary number of 40 participants has been reached, an official Call for Admission with deadline’s details will be published.