ToxHub is pleased to announce that Chiara Gazerro will participate as an invited speaker at the 2nd EuroPotent 360 Summit taking place in Milan on 20 to 22 May 2026.
This international event brings together experts from across the pharmaceutical industry to discuss the scientific, toxicological, and regulatory challenges associated with Highly Potent Active Pharmaceutical Ingredients (HPAPIs), an area where robust risk assessment and scientifically sound exposure control strategies are essential to ensure both patient safety and regulatory compliance.
During the summit, Chiara will deliver an oral presentation titled:
โ๐๐ฒ๐ฟ๐ถ๐๐ถ๐ป๐ด ๐๐ฒ๐ฎ๐น๐๐ต-๐๐ฎ๐๐ฒ๐ฑ ๐๐ ๐ฝ๐ผ๐๐๐ฟ๐ฒ ๐๐ถ๐บ๐ถ๐๐ ๐ณ๐ผ๐ฟ ๐๐ถ๐ด๐ต ๐ฃ๐ผ๐๐ฒ๐ป๐ ๐๐ฃ๐๐โ.
The presentation will explore practical approaches for the derivation of HBELs for HPAPIs, including toxicological data interpretation, uncertainty factor selection, PDE setting, and the management of data limited scenarios through weight of evidence and risk based strategies.
In addition, the discussion will highlight how integrated toxicological assessments and scientifically justified decision making can support manufacturers in navigating complex scenarios where available information may be incomplete, limited, or associated with highly potent compounds requiring very low exposure thresholds.
ToxHub at the EuroPotent 360 Summit 2026
Through its participation in the, EuroPotent 360 Summit, ToxHub shares experience and contributes to the ongoing dialogue within the pharmaceutical community.
Through a science driven and risk based approach, the ToxHub team supports the establishment of health based exposure limits, including PDEs and OELs, for both highly potent and conventional active pharmaceutical ingredients. At ToxHub, we strongly believe that effective HBEL derivation requires not only regulatory knowledge, but also a pragmatic and scientifically robust interpretation of toxicological evidence to ensure patient safety while supporting realistic and sustainable manufacturing practices.
ToxHub looks forward to engaging with colleagues, partners, and industry stakeholders during the event. Chiaraย will exchange perspectives on emerging regulatory expectations and discuss innovative approaches to toxicological risk assessment for highly potent pharmaceutical products.
If you would like to connect with us before the event, feel free to contact our team at:
info@toxhub-consulting.com or chiara.gazerro@toxhub-consulting.com.
