The cosmetic product safety assessment is becoming more and more important, also the legal safety regulations are changed continuously. According to the EU Cosmetic Regulation, the responsible manufacturer or importer has to ascertain before... bringing the products onto the market that they are not harmful to health. For that reason a safety assessor is needed, who personally is responsible for certifying that the cosmetic product is safe for the intended and reasonable, foreseeable use. This regulation serves as an important instrument for preventive protection of the consumer’s health. With the amendment of the EU Cosmetic Regulation (EC Regulation 1223/2009) of November 30th, 2009 is the safety rating to an even higher priority. Validation of formulae at the regulatory norm and the safety standard. Determination of all necessary tests of tolerance & efficiency. Validation of the labelings and claims. Safety evaluation. Cosmetic product Safety Report (CPSR) made by an expert qualified pharmacist and toxicologist. Realization & validation of the Product Information File (PIF). Notification to the Cosmetic Product Notification Portal (CPNP). Monitoring of undesirable effects and serious undesirable effects (cosmetovigilance) Regulatory monitoring of your products. Creation of CVL for exportation. Creation of regulatory exportation folder.
Profil und Kernkompetenzen: Langjährige Führungserfahrung inklusive Budgetverantwortung. Langjährigeerfolgreiche Entwicklung und Vermarktung von topischen ArzneimittelnNahrungsergänzungsmitteln (Nutriceuticals) und Kosmetika (Phyto- und Cosmeceuticals). Exzellente Kenntnisse und Erfahrung in Dermatologie inklusive der Allergologie.
Exzellente Kenntnisse der Galenikder Rohstoffe und Chemie von Naturstoffeninklusive deren BotanikPharmakologieWirkungsweiseVerarbeitung und Toxikologie. Spezialgebiet: Kosmetologie sowie Festlegung von Studiendesigns zum Wirkungsnachweis und deren Interpretation.
Methodische Führung von Innovationsprojekten Zahlreiche Entwicklungen sehr erfolgreicher Präparate auf Phyto-basis
Anerkannter Sicherheitsbewerter für Kosmetik gem. EU Kosmetikverordnung 1223/2009
Fachtechnisch verantwortliche Person Swissmedic
Medical Advisor :
PublikationenSchulungen und VorträgeEinführung und Präsentation neuer Produkte für Key- kunden und Stakeholder
Head of Regulatory Affairs (weltweit) GMP und internationales ArzneimittelrechtSpezialgebiet Kosmetikrecht in SchweizEUUSAAsien Medizinprodukte- und Biozidrecht. Alleinverantwortlich für die Kosmetovigilanz CH und EU
Managementkompetenzen in den Bereichen: BetriebswirtschaftslehreWirtschaftsrecht. Juristisches Staatsexamen in Arzneimittelrecht. Team- und Kommunikationsfähigkeit Qualitätsmanagement (DIN EN ISO 90011348514001) Change Management und Organisationsentwicklung
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