Innovating Works

HORIZON-HLTH-2024-IND-06-09

Cerrada

Temáticas obligatorias de los proyectos para la ayuda HORIZON-HLTH-2024-IND-06-09

Temática principal:
This topic focuses on transitioning from animal testing to New Approach Methodologies (NAMs) for assessing chemical and pharmaceutical safety and efficacy. The goal is for European regulators to adopt NAM-based tools, improving industry competitiveness, meeting societal demands, and enhancing regulatory frameworks to support NAM adoption and implementation. This topic focuses on transitioning from animal testing to New Approach Methodologies (NAMs) for assessing chemical and pharmaceutical safety and efficacy. The goal is for European regulators to adopt NAM-based tools, improving industry competitiveness, meeting societal demands, and enhancing regulatory frameworks to support NAM adoption and implementation.
Pharmacokinetics
Translational medicine
Pharmacology
pharmacogenomics
drug discovery and
Toxicology
Medical biotechnology
Pharmacodynamics
New Approach Methodologies (NAMs)
safety
efficacy
chemicals
pharmaceuticals
regulators
animal testing
pharmaceutical assessment
harmonised
standardised
competitive position
flexibility
societal demand
scientific evidence
limitations
regulatory safety
efficacy
European Commission
Member States
assessment tools
flexibility
regulatory framework
societal demand
animal models
decision-making contexts
chemical risk assessment
technology transfer
standardisation
technical training
Contract Research Organisations (CROs)
reliability
EU legislation
regulatory framework
obstacles
JRC
expertise
regulatory application.
Drug discovery
Chemical safety
Pharmaceutical safety
Regulatory frameworks
New Approach Methodologies (NAMs) Adoption
Regulatory Framework Enhancement
Chemical and Pharmaceutical Safety Assessment
pharmacogenomics
drug discovery
safety
efficacy
chemicals
pharmaceuticals
regulators
animal testing
pharmaceutical assessment
harmonised
standardised
competitive position
flexibility
societal demand
scientific evidence
limitations
regulatory safety
European Commission
Member States
assessment tools
regulatory framework
animal models
decision-making contexts
chemical risk assessment
technology transfer
standardisation
technical training
Contract Research Organisations (CROs)
reliability
EU legislation
obstacles
JRC
expertise
regulatory application