Biochemistry

General skills The course is the first teaching course in Regulatory Aspects of Scientific Research. Regulatory science addresses the safety and efficacy of new medical products, diagnostics and treatments. Regulatory affairs ensure new products meet the regulations and standards set by governing agencies. This course aligns regulations with science in the lifecycle of medical products. The regulatory science is also related to clinical research management focused on regulatory affairs and regulatory sciences. The students will acquire also the fundamentals on National and CEE pharmaceutical or health products laws, as well as on intellectual property and patenting. At the end of theoretical lessons, integrated by highly connotative seminars coordinated by the professor: the students will acquire the fundamentals knowledge on laws governing health and well-being products, the National Health system, the regional health system, the production and the marketing authorization of medicines and of health product with particular regard to the national and European laws. Specific skills Knowledge and understanding: -national and international pharmaceutical laws concerning production and marketing of drugs and of healthcare products (medical devices, food supplements), and concerning regulatory aspects concerning pharmacy; -devise and implement global strategies for drug, biologic, and device development and evaluation; - relate principles of clinical research design to practices in clinical trial management; - basic knowledge on intellectual property and patenting. Applying knowledge and understanding: Regulatory science/affairs positions at pharmaceutical companies, as well as medical device and biotechnology companies ability to understand the law, the economic and the administrative aspects of the health products and of the regional and national healthcare system. Making judgements: - be able to refer to specific regulatory and law texts; - be able to identify , evaluate and correlate regulatory aspects related to each specific health product. Communication skills: A classroom environment relies heavily on the quality of communication taking place within it. As an instructor, taking steps towards improving the communication skills of our students will contribute positively towards your classroom climate. Furthermore class discussion will be fundamental to develop critical and highest level of competence to be well prepared when entering the professional ranks as a new pharmacist. Learning skills The course aims to enable the transition between university and professional life and to help students to become people with lifelong learning ability and habit. The course aims to help students to become able, during their professional life, to approach to the regulatory matter, that is always evolving, for health and well being products