FOR NON-ANIMAL COSMETIC SAFETY ASSESSMENT...Consumer safety for personal care products and...
Transcript of FOR NON-ANIMAL COSMETIC SAFETY ASSESSMENT...Consumer safety for personal care products and...
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COLLABORATIONFOR NON-ANIMALCOSMETIC SAFETY ASSESSMENTT U E S D A Y , 1 2 M A R C H | 0 6 3 0 – 0 8 0 0
H I L T O N B A L T I M O R E R O O M P E A L E A - C
4 0 1 W E S T P R A T T S T , B A L T I M O R E , M D 2 1 2 0 1
0 6 3 0 W E L C O M E & I N T R O D U C T I O N0 6 3 0 C A T H E R I N E W I L L E T T , H U M A N E S O C I E T Y I N T E R N A T I O N A L
0 6 5 0 A P P L Y I N G I C C R P R I N C I P L E S T O N E X T G E N E R A T I O N R I S K A S S E S S M E N T ( N G R A )
0 6 3 0 P A U L C A R M I C H A E L & G A V I N M A X W E L L , U N I L E V E R
0 7 1 0 C H E M I N F O R M A T I C S A N D T O X I C O G E N O M I C S T O S U P P O R T T O X I C I T Y A S S E S S M E N T
0 6 3 0 G E O R G E D A S T O N , P R O C T E R & G A M B L E
0 7 3 0 E D U C A T I O N & T R A I N I N G P R I O R I T I E S : R O U N D T A B L E A N D A U D I E N C E I N P U T
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NACSAINTRODUCTION
Catherine Willett, PhDSenior Director, Science & Regulatory AffairsHumane Society [email protected]/nacsa
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CONTENTS
OUTL INE OF MODULES
INVITAT ION TO JOIN
PROJECT OVERVIEW
DESCRIPT ION OF SCOPE
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OVERVIEW
Global harmonization ofcosmetic animal testing and marketing bans in at least 50 keybeauty markets by 2023
PRIORITY REGIONS
ASEAN regionBrazilCanadaChileChinaJapanMexicoRussiaSouth AfricaSri LankaUnited States
PART 1
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OVERVIEWInvestment in educationand training
Capacity-building to achieve long-term acceptance and implementation
Regulated and regulatory communities, CROs
Global and multifaceted curricula
PART 3
Sharing information on decision-making approaches withoutnew animal testing
Risk-based safety decisions through integration of scientific evidence from multiple sources
Exposure-led, product and use-specific, iterative safety decision frameworks
Relevant case studies from multiple stakeholders
PART 2
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SCOPE
Exposure, hazard and risk decision-making approaches without the use of animals
Regulatory and non-regulatory decisions
Consumer safety for personal care products and ingredients
Collaboration between industry, consultants, CROs, regulators
Development of frameworks and case studies
Initial priority regions US, EU, China and Brazil (followed by India, Korea and Japan and others)
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ELEMENTS
Overview of exposure-led, non-animal risk assessment approaches
Problem formulation
Decision-making frameworks
Point-of-departure determinationUncertainty characterizationGovernance for traceability/transparency
Risk assessment case studies
DECISION-MAKING
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MODULES
Exposure-led risk assessment
Determination of acceptable exposure limitsScenario-based exposure calculations
Predictive chemistry
(Q)SAR, read-across
History of safe use
Data generation (in vitro methods)
Next-generation risk assessment approaches
Exposure (PBPK, free concentration, metabolism)Tiered approach (in silico, in vitro)Computational modeling
Delivery
Webinars, videos, 1-pagers, website, continuingeducation sessions, symposia, academic lectures & collaborations
TOOLS & APPROACHES
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INVITATION
Partners in developing detailed plansfor capacity building and education, and ensuring globally harmonized legislation
Interest in any or all of the 3 project elements
Broad range of stakeholders, groups and organisations, many ways to contribute!
Expertise with specific modules
CONTACT [email protected]
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COLLABORATIONFOR NON-ANIMALCOSMETIC SAFETY ASSESSMENTT U E S D A Y , 1 2 M A R C H | 0 6 3 0 – 0 8 0 0
H I L T O N B A L T I M O R E R O O M P E A L E A - C
4 0 1 W E S T P R A T T S T , B A L T I M O R E , M D 2 1 2 0 1
0 6 3 0 W E L C O M E & I N T R O D U C T I O N0 6 3 0 C A T H E R I N E W I L L E T T , H U M A N E S O C I E T Y I N T E R N A T I O N A L
0 6 5 0 A P P L Y I N G I C C R P R I N C I P L E S T O N E X T G E N E R A T I O N R I S K A S S E S S M E N T ( N G R A )
0 6 3 0 P A U L C A R M I C H A E L & G A V I N M A X W E L L , U N I L E V E R
0 7 1 0 C H E M I N F O R M A T I C S A N D T O X I C O G E N O M I C S T O S U P P O R T T O X I C I T Y A S S E S S M E N T
0 6 3 0 G E O R G E D A S T O N , P R O C T E R & G A M B L E
0 7 3 0 E D U C A T I O N & T R A I N I N G P R I O R I T I E S : R O U N D T A B L E A N D A U D I E N C E I N P U T
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What are your priorities for development of education and training materials for the various modules? 1st, 2nd, 3rd choices?
What stakeholders, groups or organisationshave we missed or inclusion in project? for outreach?
How would you like to see education andtraining materials provided? In what format?
AUDIENCE QUESTIONS
www.menti.com [code: 74 58 07 ]
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MODULES
Exposure-led risk assessment
Determination of acceptable exposure limits Scenario-based exposure calculations
Predictive chemistry
(Q)SAR, read-across
History of safe use
Data generation (in vitro methods)
Next-generation risk assessment approaches
Exposure (PBPK, free concentration, metabolism) Tiered approach (in silico, in vitro)
Computational modeling
Webinars, videos, 1-pagers, website, continuingeducation sessions, symposia, academic lectures
& collaborations
TOOLS & APPROACHES
DELIVERY
Webinars, videos, 1-pagers, website, continuingeducation sessions, symposia, academic lectures
& collaborations
Exposure-led, non-animal risk assessment approaches
Problem formulation
Decision-making frameworks
Point-of-departure determination Uncertainty characterization Governance for
traceability/transparency
Risk assessment case studies
DECISION-MAKING ELEMENTS
www.menti.comcode: 74 58 07