Master in Regulation and Evaluation of Medicines and Health Products

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The main aim of this unit is to provide students with background on Medical Devices, Homeopathy and cosmetic products. In particularly, at the end of the course students should:

i) be able to identify biomedical applications of medical devices;
ii) be capable to classify medical devices;
iii) be aware of regulation, economic impact and innovation in the field;
iv) Concepts of Homeopathy
v) Evaluation of Pharmaceuticals dossier Homeopathic
VI) Regulatory framework and scope of Cosmetic products
VII) Claims and safety of Cosmetic products

Additionally this curricular unit will allow students to develop their skills on the Medical Device theme and consolidate previous knowledge on health-related subjects as physics, physiology and imunology.

Medical Device’s Regulatory frame
(a) New Approach, definitions, classification and frontiers. Examples and requisites for placing on the market; (b) The role of the main actors: competent authorities, notified bodies, manufactures and distributors; (c)Conformity assessment: procedures, essential requirements, clinical evaluation; (d) Vigilance and post-market surveillance; (e) Medical devices risk

2. Concepts of Homeopathy

Peculiarities of homeopathic approach versus clinical evaluation of the patient’s file. Evaluation of Pharmaceuticals dossier Homeopathic simplified registration.

3. Definitions and Legislation PCHC. Technical Notebook. Safety assessement.

Evaluating the effectiveness of cosmetic products. Evaluation of labeling and advertising of PCHC.