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

NACSAINTRODUCTION

Catherine Willett, PhDSenior Director, Science & Regulatory AffairsHumane Society Internationalkwillett@hsi.orghsi.org/nacsa

CONTENTS

OUTL INE OF MODULES

INVITAT ION TO JOIN

PROJECT OVERVIEW

DESCRIPT ION OF SCOPE

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

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

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)

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

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

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 KWILLETT@HSI.ORG

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

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 ]

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