Programme
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Coffee and Registration
- Session 1: Global Issues
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Keynote Keynote address
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Global strategies for tackling chemicals testing
- The Science of Product Safety
- Concept of Core Dossier for global notifications
- The benefits of integrated data generation
- The good use of Confidentiality Business Information for global notifications
Matthieu Duchemin
Head of CPC Expert Consultant Group and AsiaPac Regulatory Services, Envigo, United Kingdom -
Toxicology demystified – why it matters to non-toxicologists
- Perception of safety risks can be emotive
- Why safety & toxicology matters!
- Understanding risk, hazard & exposure
- Understanding distribution & metabolism
- What is a safety assessment
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Q&A
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Refreshments
- Session 2: updates on practice across ASEAN
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Regulatory toxicological data requirements of China covering chemicals, food contact and cosmetics
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Taiwan – hazardous chemicals management and risk assessment
- Introduction to the chemical management scheme in Taiwan
- Hazard assessment and risk assessment under TCSCA and OSH Act
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Japan – Risk Assessment concept and Regulatory Science
- Regulatory science framework for product safety
- Practical workflow of product safety assessment
- State of the art concept for objective risk assessment
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Q&A
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Lunch
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South Korea – risk assessment for high risk Products and safety standards and labelling
- Introduction to the Consumer Chemical Products and Biocides Safety Act (K-BPR) in Korea
- Management system of the consumer chemical products in Korea
- Risk assessment for the safety standards of the consumer products in K-BPR
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Hazardous chemicals management and risk assessment in Malaysia – an update
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Toxicological Risk Assessment: practice from an industry company in China
- Risk assessment under New Chemical Substance Registration in China
- Screening risk assessment
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Q&A
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Refreshments
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Australia – risk assessment methods used by the authorities
- At its most basic level the use of toxicology in risk assessment is a scientific basis for making decisions about chemical use and chemical approval.
- With time, regulation and social development the decision making process evolves to match societal expectations.
- This presentation will explain current science policy and risk assessment practice in Australia.
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Labelling and post-marketing regulatory aspects of labelling in Australia
- Label warnings on chemical products as a key part of risk management, and the two such systems operating in Australia.
- The Globally Harmonised System (GHS) of pictograms and warning statements
- Label warnings on products available to the public via retail outlets, how these are determined and harmonised by the Uniform Scheduling of Medicines and Poisons (SUSMP, or Poisons Standard)
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Europe – risk assessment and the REACH Regulation
- Risk assessment under REACH
- Hazard: Comparison between REACH and CLP
- Exposure considerations (Thresholds, calculated and measured values)
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Q&A
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Close of Day One
