The webinar explains how novel methodologies are developed and approved through expert committees, eventually becoming internationally accepted standard methods used by governments, industry and independent laboratories to assess the safety of chemicals.

The webinar is relevant for any stakeholder interested in how chemicals are developed and demonstrated as safe for market, within a global framework of countries.

Wed, September 16, 2020, 2:00 PM – 3:30 PM CEST

This virtual meeting will include a perspective from Bob van de Water (University Leiden, DESI) and a discussion session. 

High drug attrition rates are the main cause for the (exponentially) increasing healthcare cost. The lack of predictive in vitro models to either accurately test drug efficacy or determine toxic side effects in an early phase of drug development is causing this high failure rate. At Leiden University we developed the innovative SafeDESIgn reporter platform that we use to accurately assess the efficacy and/or safety of chemicals. The generated fluorophore reporter cell lines can be imaged with a confocal microscope over time so that we can accurately quantify the early dynamic adaptive signaling changes. By doing so we can not only determine if a chemical at a certain concentration is toxic, but also which adaptive/adverse pathways are activated. This is crucial information if we want to predict human safety levels for these chemicals.

This virtual meeting will include a perspective from Laszlo Urban (Novartis) and a discussion session. 

Excipients, considered “inactive ingredients”, are a major component of formulated drugs and play key roles in their pharmacokinetics.  Despite their pervasiveness, whether they are active on any targets has not been systematically explored.  We computed the likelihood that approved excipients would bind to molecular targets.  Testing in vitro revealed 25 excipient activities, ranging from low-nM to high-μM.  Another 109 activities were identified by testing against clinical safety targets.  In cellular models, five excipients had fingerprints predictive of system-level toxicities.  Exposures of seven excipients were investigated, and in certain populations, two of these may reach levels of in vitro target potency. While most excipients deserve their status as inert, many approved excipients may directly modulate physiologically relevant targets.

This virtual meeting will include a perspective from Thomas Steger-Hartmann (Bayer) and a discussion session. 

Sharing of preclinical data among pharmaceutical companies which are otherwise perceived as competitors is both a challenging but also rewarding endeavor. The challenges which need to be overcome are legal reservations, issues around data security, standardization and curation. The benefits of data sharing lie in the development of common standards (e.g. for terminologies in the field of histopathology), the possibility to test mechanistic hypotheses and structural relationships in a wider chemical and pharmacological space and ultimately to contribute to the refinement and reduction of animal studies.

Overview of ILO’s resources for developing and maintaining OSH management systems, followed by examples from existing national systems.

Wednesday, 15 July 2020, 10:00–11:30 CET

Registration

Overview of how chemical incidents are managed from a public health perspective (risk assessment, management options, communication, and surveillance); includes an interactive exercise.

Wednesday 8 July 2020, 14.00-15:30 CEST

See flyer for further information.

The general theme of the congress is “Key enabling non-animal technologies for research, education and testing”. This slogan is fully reflected in the eight thematic sessions. The congress programme also consists of a number of special sessions, including a continuous poster session, student sessions, European project sessions and lunch sessions. The congress will be preceded by a complimentary workshop and will be followed by a hands-on workshop.

This colloquium will feature an emerging flexible approach to evaluating and generating information to meet different regulatory purposes by means of Integrated Approaches to Testing and Assessment (IATAs). IATAs are pragmatic, science-based frameworks for chemical hazard or risk characterization, which follow an iterative, integrative approach to answer a defined question with the required certainty in a specific regulatory context.

Anne Gourmelon, OECD Environment Directorate (chair); Karolina Gutt-Mostowy, European Commission JRC, will present the fair, reasonable and non-discriminatory (FRAND) terms for licenses; Sharon Bahia from the European Collection of Authenticated Cell Cultures of Public Health England will discuss the role of biological resources banks and collection in maintaining traceability of protected material.

The development of new chemical compounds holds the potential risk of harmful mutagenic and/or carcinogenic effects to humans. Minimizing these risks during drug development requires appropriate experimentation and expert knowledge whose basic principles will be delivered with this course. Special emphasis will be given to the biology of cancer formation, the identification of mutagens and carcinogens and their modes of action on the cellular, biochemical and molecular level. In silico methods prediction as well as animal test systems and tissue culture assays for carcinogenicity testing will be presented. Furthermore, the importance of responsibly estimating dose-dependent probabilities of mutagenic/carcinogenic effects (risk assessment) and the risk-benefit evaluation will be discussed.