Theme I Safety and Efficacy Testing of Chemicals, Pharmaceuticals and Biologicals
I-1
Potency and safety testing of human vaccines

This session will focus on new Three Rs technologies and testing approaches, and how they can replace current testing methods for safety and efficacy.

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I-2
Addressing systems toxicology

This session aims to consider the needs of industry and the potential role of systems biology in toxicity testing and product evaluation.

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I-3
Biological and biotechnology-based therapeutics

This session will examine the challenges and potential solutions to the development and safety testing of biological and biotechnology-based therapeutics.

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I-4
Regulatory testing paradigms and validation of alternative test methods for detecting estrogen active substances; impact on the Three Rs

This session will examine potential approaches to evaluate endocrine active substances.

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I-5
Nanotoxicology and the Three Rs

This session will examine the promise and limitations of emerging alternative approaches for evaluating nanomaterial toxicity and explore opportunities for future Three Rs efforts.

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I-6
Advances in alternative methods for ecotoxicology

This session will highlight advances in Three Rs methods for environmental risk assessment and approach the broad field of alternatives from not only a toxicity-endpoint driven approach, but also from a process-driven, integrated assessment strategy approach.

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I-7
Potency and safety testing of veterinary vaccines

This session will examine major advances in alternative methods that incorporate the Three Rs into vaccine potency and safety testing strategies for veterinary vaccines.

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I-8
Safety testing for chemically-induced eye injuries: Recent Three Rs advances

This session will take a Three Rs approach to consider both replacement models and recommendations for refinement of endpoints and pain management where animals are still required.

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I-9
Advances in Three Rs alternatives for reproductive and developmental toxicity

This session will focus on the recent advances in the use of in vitro methods for human risk evaluation for reproductive and developmental toxicity. It will also examine progress made in the use of organisms such as zebra fish and C. elegans.

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I-10
Safety testing for carcinogenicity and genetic toxicity: recent Three Rs advances

This session offers the opportunity to examine progress with new Three Rs methods and testing paradigms for carcinogenicity testing.

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I-11
Three Rs approaches to skin sensitization

This session will examine developments in the use of the LLNA as well as advances in the science of non-animal approaches to skin sensitization, including the validation status of in silico and in vitro methods.

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I-12
Epigenetics and its Increasing Relevance in Toxicology

This session will cover the several aspects of epigenetics, including its impact and applications, in a toxicological context. In a first instance, xenobiotics that trigger a toxicological outcome, such as carcinogenic and transgenerational effects, by interfering with epigenetic homeostasis will be addressed. Special attention will hereby be paid to new approaches that allow detection of epigenetic toxicity as well as to strategies that enable incorporation of epigenetic toxicity data in chemical risk assessment. On the other hand, it will be discussed how epigenetics can be exploited in such a way that it can actively contribute to the implementation of the Three Rs principle in toxicology. Of particular interest in this regard is the modification of the epigenome in the process of establishing organ-specific and stem cell-based in vitro models applicable for long-term toxicity testing purposes.

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I-13
Additional Session: Toxicity testing in the 21st century

The Tox21 Community consists of a group of federal programs and centers in the United States who have collaborated since 2008 on the research, development, validation, and translation of new and innovative test methods which characterize key steps in toxicity pathways. This session will discuss progress to date in meeting the Tox21 goals, focusing on the strategies for chemical and assay selection, workflows for data management and analysis, and follow-up studies of novel findings.

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I-14
Additional Session: Comparing the challenges of implementing new non-animal methods in the US and Europe

The European Society for Toxicology In Vitro (ESTIV) and the newly created American Society for Cellular and Computational Toxicology (ASCCT) is holding a combined session to compare and contrast the challenges of developing and implementing new alternative (non-animal) methods in the US and Europe.

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I-15
Additional Session: Shellfish toxin testing: how are the Three Rs being progressed in this field?

This session aims to look at some of the reasons why animal tests continue to be used in this age of modern analytical methods, whether and how the three Rs can be implemented and provide an update on the current state of play in this field.

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I-16
Additional Session: Alternatives for potency testing of rabies vaccines

Batch potency testing of rabies vaccines for human and veterinary use involves large numbers of mice and inflicts severe pain and distress on the animals. The session will report on problems, possibilities and recent achievements in the quality control of rabies vaccines.

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I-17
Additional Session: Update on new in vitro models for detection an potency assessment of botulinum neurotoxin

This session will provide an overview of these new in vitro methods and discuss applications where they are expected to reduce and replace animal use.

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I-18
Additional Session: Report on the ICCVAM International Workshop on Vaccines

This session will discuss recommendations from the 2010 NICEATM-ICCVAM International Workshop on Alternative methods for the reducion, refinement, and replacement of the use of animals in human and veterinary vaccine potency and safety testing.

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I-19
Additional Session: Toxicity testing strategies - progress in skin sensitization testing: A COLIPA supported session

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