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The Master objective is to shape graduates coming from different backgrounds into new professionals in the regulatory sciences. The last decade has brought a remarkable development in international regulations and, as a result, firms and agencies in the Health and Industrial Sectors are in need of professionals specialised in regulatory sciences with the following characteristics:
- ability to plan, prepare and evaluate any type of regulatory procedure, especially the registration dossier;
- knowledge of the English language and of the most commonly used software, including automated data acquisition systems and data management;
- necessary scientific knowledge in all aspects of chemical, pre-clinical and clinical research;
- juridical and economic knowledge, in-depth knowledge of National, European and International laws, registration procedures and different regulatory steps behind the development of drugs;
- ability to interact with a company's offices dealing with drug development and with all the external bodies involved, especially the Health Authorities;
- basic technical-scientific knowledge in the three Quality Control areas: GMP, GLP, GCP.
- knowledge of the rules and procedures for production site audits, laboratories and clinical trial centres;
- knowledge and ability to plan regulatory strategies and inclination to "problem solving"
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