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Carla Landolfi, ERT
CEO & Founder presso ToxHub Srl - European Registered Toxicologist - Toxicology Risk Assessor- Preclinical Development & Biocompatibility expert
Carla Landolfi, ERT, is the CEO and Founder of ToxHub Srl, a consultancy company specializing in toxicological risk assessment.7 As a Toxicology Risk Assessor, she brings her expertise to the field of product safety evaluation.
ToxHub Srl
ToxHub is a dynamic and proactive consultancy company that offers a broad range of toxicological expertise in the pharmaceutical, chemical, and healthcare sectors.16 The company was founded in Rome in 2020 and has since established itself as a partner in toxicological risk assessment for various industries.5
Services and Expertise
ToxHub provides toxicological risk assessment (TRA) services for products manufactured and sold across multiple industries.2 Their expertise extends to:
- Drug safety
- Medical devices
- Biocides
- Cosmetics3
The company's focus on toxicological risk assessments (#TRA) involves evaluating product safety, which is crucial for ensuring consumer protection and regulatory compliance.4
Company Growth
In November 2022, ToxHub was acquired by SenzaGen, indicating the company's growth and value in the toxicological consulting industry.5 This acquisition likely expanded ToxHub's resources and reach in the field of toxicological risk assessment and regulatory strategy consulting.
Carla Landolfi's role as CEO and Founder, combined with her ERT (European Registered Toxicologist) designation, suggests that she possesses significant expertise and leadership in the field of toxicology and risk assessment. Her position at the helm of ToxHub Srl demonstrates her commitment to advancing product safety across various sectors.
Highlights
I’m super excited to share that I’ll be attending the EUROTOX Congress in beautiful Copenhagen, Denmark!
If you’d like to meet up, my colleague Chiara Gazerro and I will be at booth #56 with the SenzaGen Team.
We’re also thrilled to present two posters:
💡 Workflow for #Occupational #Exposure Limit Determination and #Banding: Focus on Skin and #Respiratory #Sensitization using #NAMs approaches (P23-21)
💡 #Risk #Assessment Approaches for #Nanomaterials in Medical Devices (LP-28)
Don’t miss out – I can’t wait to see you there 😉 !
If you want to get in touch with us beforehand, just drop us an email at [email protected]
💻 www.toxhub-consulting.com 📩 [email protected]
#EuroTox2024 #EuroTox #ToxHub #Consultancy #Tossicologia #Toxicology
Are tampons safe enough given their current regulatory status?
It's intriguing to note that tampons are not classified as medical devices in Europe, but they are under the FDA. Recently, a study titled "Tampons as a source of exposure to metal(loid)s" analyzed a range of tampons for the presence of heavy metals, which were detected in trace amounts. This article is raising concerns among consumers about the safety of these products. Is this data so surprising and worrying?
In the USA, as MDs, chemical characterization is a mandatory requirement according to ISO 10993, and these evaluations should have been part of the biocompatibility process. Surely, manufacturers must have conducted their toxicological risk assessments in accordance with ISO 10993-17 and 18. In contrast, the EU restricts the concentrations of Pb, Cd, Cr (VI), and As in textile fabrics to be less than 1 mg/kg, and the quantities found in the tampons were well below these limits.
However, my question is: is it appropriate (for the European market) for this type of product to have limits based on concentration (ppm)? Wouldn't it be more accurate to conduct a risk assessment that considers actual exposure?
#Health #MedicalDevices #Regulations #Safety #Tampons #Research
