How NAMs Can Further Your DART Programs
Chemical, agrochemical, and pharmaceutical companies are facing unprecedented challenges in maximizing resources, minimizing animal usage, and accelerating registration timelines, while maintaining regulatory compliance. In this context, New Approach Methodologies (NAMs) are gaining traction, but as product developers, questions remain about how they can be integrated into development programs. How far can NAMs go in supporting go/no-go decisions, and what is their reliability in predicting or replacing in vivo data?
View this two-part webinar series, each session lasting one hour, where you can explore how companies can strategically integrate NAMs and in vitro methods into testing and development workflows. You can learn from our experts on practical approaches to ensure regulatory acceptance and streamline innovation for your endocrine disruption (ED) and developmental and reproductive toxicology (DART) programs.
Each session includes a live Q&A to address your most pressing questions.
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Discover New Approach Methodologies (NAMs) for Your Endocrine Disruptor and DART Programs
Strengthen your DART strategy by aligning with evolving regulatory expectations and leveraging innovative testing approaches.
Endocrine disruptor (ED) testing, including in vitro and New Approach Methodologies (NAMs), has paved the way for early safety insights and streamlined regulatory pathways. The lessons learned from ED programs are now informing and accelerating DART initiatives, offering a path toward reduced animal testing and enhanced regulatory confidence.
In this expert-led webinar explore how companies can:
- Apply ED-focused NAMs to refine DART programs
- Meet regulatory demands
- Adopt future-ready alternatives
Gain Efficiencies in Your DART Programs with Newly Developed NAMs Assays
As expectations evolve under EU REACH and ICH S5 (R3) regulations, the validation and acceptance of New Approach Methodologies (NAMs) can help support and strengthen regulatory confidence in their use in developmental and reproductive toxicity (DART) testing.
The ReproTracker® assay is a human induced pluripotent stem cell (hiPSC)-based system used to investigate whether (agro)chemicals or therapeutics interfere with early embryonic development. Whether you’re in early discovery or late-stage development, ReproTracker empowers faster, more confident decision-making and can quantitatively predict teratogenic potential.
In this expert-led webinar learn how to:
- Complement traditional in vivo toxicology methods with the validated ReproTracker assay
- Extrapolate animal-derived results compared to humans and ensure regulatory confidence
- Reduce risk and uncertainty in early and late-stage DART testing
- Gain efficiencies in your DART programs through our collaboration with Toxys
Webinar Presenters
Pragati Coder, PhD, DABT
Global Lead, DART, C&C, Senior Director, DART, Juvenile and Neurotoxicology, Charles River
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