Philippe DE CARVALHO

Review of advertising and promotional materials for OTC drug - Review of labelling for preparation products.
Prepare & review regulatory submissions to competent authority for phase IV trial according the new french regulation (both French Drug Agency for the security of health products (AFSSaPS) & Ethic committee approvals).
Provide regulatory advice for refunding affairs
Pharmacovigilance: participation to regulatory coordination in collaboration with medical department
Monitor & maintain an awareness of evolving regulatory requirements and guidances
Manage other specific legal or regulatory affairs, as necessary (taxation, borderline products...)
Substitute regulatory affairs for cosmetic products in the company.

Sector: Health and pharmaceutical

Review regulatory documentation and prepare regulatory submissions in area of expertise, as appropriate for Phases I & II clinicals trials (study protocol, study amendment, informed consent document, dossier for EC)
Provide technical input consultancy and technical review for regulatory matters
Interact with Regulatory Autorities (Afssaps, Ethics Committee...)
Interact with internal (other Forenap Pharma departments) and externals clients in area of expertise
Keep up-to-date with regulatory knowledge, trends, and developments in the area of expertise.

Sector: Health and pharmaceutical

(Unternship followed by a temporary position)
Prepare european cosmetic dossiers for GUCCI, ESCADA, ROCHAS... products
Prepare and provide international registration documentation as needed for export
Review of cosmetic product labelling according to european & international requirements
Responsable with costumer service and follow-up of cosmetovigilance cases.

Sector: Luxury Goods and Cosmetics

(Unternship followed by a temporary position)
Prepare legal documentation relating to the risk of BSE transmission to human beings by use of cosmetic products (Bovine Spongiform Encephalopathy)
Analysis of the consequences of the implementation of the seventh amendment of the European Directive n° 76/768/CEE for Cosmetic Industry
Legal qualification of health products within the area of “borderline products”
Participation to the working group which evaluated the requests relative to “VISA PP” (French specificity about the control of health claims)

Sector: Health and pharmaceutical