Maria Labianca
Regulatory Toxicologist - Medical Device and Consumer Products Specialist @Toxhub Srl
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WORK HISTORY
Regulatory Toxicologist - Medical Device and Consumer Products Specialist @Toxhub Srl
Drafting of the Biological Evaluation Plan and Biological Evaluation Report (BEP and BER) within a risk management process, in accordance with ISO 14971, 10993 and MDR; Conducting and evaluating Gap Analysis according to ISO standards and MDR; Interpretation of the results obtained from Biocompatibility testing according to ISO 10993-1; Preparation of technical documentation for medical devices according to the MDR regulation; Toxicological assessment of MD components according to ISO 10993 and MDR; Toxicological risk assessment for residual impurities from the production process (ISO 10•••18), for degradation products (ISO 10•••13/14/15), and for substances extracted and/or released from the primary packaging in the Medical Device (ISO 10•••17) including polymers (plastic/silicone), solvents, elemental and genotoxic impurities, and definition of their safety limits; Preparation of the Product Information File (PIF), CPSR (Part 2A and 2B) according to the European regulation on cosmetics 1223/2009; Safety assessment of cosmetic ingredients and definition of the safety profile of finished cosmetic products, according to European Cosmetic Regulation 1223/2009, including nanomaterials, fragrances, sensitizers. Calculation of safety margins including those related to the pediatric population and setting the appropriate exposure dose; Evaluation and justification of CMR and ED risks; Response to non-conformities by Notified Bodies/Authorities; Scientific support for the development of medical devices and cosmetics; Ensure that all components used in the product comply with regulatory registrations and limitations; Production of Scientific Reports; In-depth analysis of large datasets and online literature; Marketing, including LinkedIn and Blog Posts; Knowledge of international regulations and guidelines.
EDUCATION
License to Practice as a Pharmacist
University of Bari "Aldo Moro"
Registration in the Pharmacists' Register of the Province of Bari and BAT
Pharmacists' Order of the Province of Bari and BAT
Master's Degree in Pharmacy (Class LM-13)
University of Bari "Aldo Moro"
Second-Level Master’s Degree in “Cosmetic Product Sciences” with Honors
University of Bari "Aldo Moro"
ABOUT MARIA LABIANCA
Regulatory toxicologist - Medical Device and Consumer products Specialist
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