Class Safety and Efficacy

The safe use of Health Products and Food Supplements (PSSA) is discussed and developed in a different context compared with medicines , given the assumption of "no risk" implied. Additionally, a new concept of efficacy is now assumed, often requiring proof of effect. These two aspects are crucial today for the formal commercialization of the PSSA whose regulation requires an increasingly rigorous and objective approach to these issues. It is in this context that this curricular unit (UC) is justified, systematizing the essential information determined by objectives specified ahead.

Ethical and Deontological Aspects
Medical Devices - Risk Management
Harmonized standards NP EN ISO 10993 - 1: 2004 and EN ISO 14971: 2006. Pre-clinical evaluation
Safety and effectiveness of Food Supplements. Analysis of the Benefit - Risk ratio. Border products
Cosmetics. Human skin and its properties - race, age, sex and "type". Basics of safety and effectiveness.
"Barrier" function and epidermal water dynamics. Biomechanical properties. The depression structure (wrinkles) and morphometry. The chemical, anti-oxidant and microbiological barrier - the microbiome.
Microcirculation and adipose tissue.
Hands-on
Medical device risk management plan. Pre-clinical data (Safety file)
General basic characterization of human skin - experimental protocol for study of efficacy
Study whether the safety and effectiveness of a standard product. Experimental draw. Case Study
Risk Ratio - Benefit of Food Supplements - Practical cases

the discipline uses multiple active teaching strategies in order to stimulate deductive reasoning (papers discussion and analisys, oriented by an experienced tutor; PBL..)

Maibach HI, Honari G., (2014) Applied Dermatoxicology, 1st Edition, Cambridge, Academic Press

Serup, J. et al., (2006). Handbook of non-invasive methods and the skin, Second Edition, Boca Raton, CRC Press

Martini, MC, (2011). Introduction à la dermopharmacie et à la cosmétologie, London, Editions Tec and Doc

Walters, K.A., (2002) Dermatological and transdermal formulations, New York, Ed. Marcel Dekker Inc.

Rodrigues LM.  (2014) ¿Discussing Cosmetics through a Functional Scope¿ in ¿Advances in Dermatological Sciences¿ Ed. Brain KR and Chilcott RP, RSC Publ, London , Ch20, pp-240-255