toxicological risk assessment & product safety forum 2017 · toxicological risk assessment...

Toxicological Risk Assessment & Product Safety Forum 2017 - 15 February 2017, Singapore

[email protected] +44 (0)1743 818 297 www.chemicalwatch.com/Product_Safety_Forum

Toxicological Risk Assessment & Product Safety Forum 2017

Event introduction

The Toxicological Risk Assessment & Product Safety Forum is a brand new event from Chemical Watch and Chemical Risk Manager. It will focus on how countries are evaluating risk, and ensuring safe products - such as personal care/consumer products, food and medical devices - are put into the market.

This event promises to be the first-of-its kind in Asia Pacific. Bringing together over 15 experts in global chemical risk assessment and regulation, from industry, agencies and professional organisations, this one-day practical conference will include presentations, round table discussions and interactive Q&A sessions to raise awareness and standards of Risk Assessment and Products Safety in Asia Pacific.

Speakers at the conference include key industry stakeholders, regulatory toxicologists from agencies in the EU (including European regulators), Asia Pacific, and ACTRA (Australasian College of Toxicology and Risk Assessment). They will cover a wide range of topics, including food, consumer products, personal care products, chemicals (including biocides and pesticides) and therapeutic goods/life science products. There will also be updates from Singapore, Malaysia, South Korea, Thailand, Australia and Japan, along with an update on REACH and the role of ECHA, together with the latest news from industry case studies.

Supported by the Singapore Manufacturing Federation, this conference offers a unique opportunity to stay in line with international chemicals regulation and expectations of chemicals risk management in products.

15 February 2017, Singapore

Who should attend?

Why attend?

Expert speakers on handListen to senior representatives from both government and industry, together with NGOs: discover where the risks lie in your product development strategy.

Latest joined-up thinkingGet to know the latest scientific knowledge about the adverse impacts of chemicals in everyday products.

Expert panelListen to senior representatives from Risk Assessment regulators together with senior industry representatives: learn about the regulatory hurdles you will need to overcome in order to successfully launch products in other countries.

Q&A panel discussionHave your specific questions answered by making use of the multiple Q&A sessions. Remember - we encourage you to send in any questions you might have in writing in advance of the conference.

The conference is essential for organisations - public, private, NGO’s and academia - who need to understand current legislation, research, methodologic, and practice issues that are the focus of toxicology and risk assessment efforts in various Asia-Pacific countries.

This event is supported by:

C30 M0 Y95 K0

C60 M5 Y95 K0

C0 M0 Y0 K70

C0 M50 Y100 K0

C30 M0 Y10 K0

C60 M10 Y5 K0

mailto:[email protected]

https://chemicalwatch.com



08.30 Registration & Networking

09.00 Welcome

Mr Douglas Foo, President, Singapore Manufacturing Federation

09.15 Keynote address: Risk based management of chemical hazards. What’s it all about?

• History of Human Health Risk Assessment (HHRA - environmental and occupational)

• Improving RA methods relating to environmental health

• Chemical Regulation in Australia: history and current overview

Dr Peter Di Marco, Australasian College of Toxicology and Risk Assessment (ACTRA)

Chair: Dr Keng-Meng Khoo, Head of Regulatory Asia, Lonza

09.40 Overview of NEA’s Hazardous Substances Management in Singapore

Ms Stefanie Koh, Scientific Officer from the Pollution Control Department, National Environment Agency

10.00 Guiding Principles for Complementary Health Products (CHP) Safety Assessment

Ms Hui Foong Mei, Director – CHPB, Complementary Health Products Branch, Pre-Marketing Division, Health Sciences Authority, Singapore

10.20 Regulatory Framework on Chemical Management in Thailand

In Thailand, the Department of Industrial Works (DIW), the competent authority (CA) for industrial chemicals, has initiated the regulatory framework on chemical management which aims at enhancing the current control through the Hazardous Substances Act (HSA) to become more risk based approach (REACH like system). This session will mainly focus on the current and future plan of DIW in progressing such changes in the coming years towards the achievement of SAICM goals in 2020.

Mr Chalermsak Karnchanawarin, Managing Director of HazChem Logistics Management Co. Ltd., Thailand

10.40 K-REACH and the new biocide regulation: update on progress and the methods that may be used for biocide risk assessment under the new system

• Update on K-REACH and product management including biocide

• Risk assessment for K-REACH; CSA procedure and CSR format, use descriptor, SIMPLE BOX for environmental emission

Session 1: Country updates

• Risk assessment for highly risk concerned product and Safety standard & Labelling

Ms. Yunjin Jean Cho, Assistant Manager, New Chemical Assessment and Regulatory Affairs, Chemtopia Co. Ltd, South Korea

11.00 Q&A

11.15

11.35 REACH: contribution to a safer use of articles

• Main principles of REACH

• What the tools REACH contains serve the objective of safer use of articles and how these have been implemented (with what results) so far

• What areas of improvement or further developments can be envisaged for the future

Remi Lefevre, Scientific Officer, ECHA, Finland

11.55 Risk Assessment methods used by authorities in Australia (NICNAS, APVMA, TGA) and how these assessments are tied to the registration process

Australian risk assessment practice is dependent on the type of chemicals. Overall the techniques are consistent with international guidelines. Industrial and agricultural chemical assessment methodologies have relied on the International Programme for Chemical Safety and for medicines the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Recent focus for regulators has been how to balance regulatory effort based on risk. Besides a description of toxicology and risk assessment approaches in regulatory risk assessments in Australia. The presentation will consider the rapid assessment of existing chemicals by NICNAS and recent developments in APVMA risk assessment.

John Frangos, Associate, Principal Toxicologist, Golder Associates Pty Ltd, Australia

12.15 Risk assessment framework and Regulatory Science updates in Japan

• The framework of the Japanese Regulation and the Regulatory Science

• Risk assessment for Japanese Cosmetics and quasi drugs, Chemical raw materials, Food/ Fictional food, Consumer products

Dr Kenkichi Fujii, Senior Risk Assessor, R&D - Safety Science, Kao Corporation

12.35 Q&A

12.50

Coffee break

Lunch & Networking





13.50 ASEAN Guiding Principles on Safety Substantiation of Health Supplements. A case study - safety substantiation of a new active ingredient

Mr Darwin Lai, Regulatory Affairs Manager Asia Pacific, DSM Singapore Industrial Pte Ltd

14.10 The USA Risk Assessment landscape: industry expert

Dr Jeremy Wong, Product Safety and Toxicology, The Estée Lauder Companies, Inc., USA

14.30 Global non-animal-testing policy for cosmetics, chemicals and pesticides

Decades of investment in novel testing approaches to replace, reduce or refine animal use in toxicology have yielded a diverse toolbox of validated in vitro methods, non-testing and other innovative strategies that could be put to immediate use across a number of product sectors. Case studies from the pesticide and chemicals sectors will be used to examine progress and ongoing efforts toward uptake of available 3R approaches in key markets in the context of current international best practice and the ultimate goal of 21st century non-animal toxicology articulated by the U.S. National Research Council.

Tina Qu, Regulatory Affairs Manager, Vshine

14.50 Q&A

15.05

Chair: Mr Albert Khoo, Business Development and Regulatory Affairs Manager, 3M Technologies (S) Pte Ltd

15.25 Industry expert: case study

Dr Seok Kwon, Procter & Gamble, Singapore

15.45 Environmental Risk Assessment

Mike Freemantle, Head of Regulations, Lonza

16.05 Human Health Risk Assessment

Laura Robinson, Toxicology Consulting Ltd, UK

16.25 WHO Human Health Risk Assessment Toolkit: Towards Improved Chemical Risk Assessment

The World Health Organization (WHO) Human Health Risk Assessment Toolkit was developed to aid decision making on potential risks of chemicals exposure. It demonstrates how to identify and acquire information needed to assess chemical hazards, exposures and risks and utilize the information to estimate potential exposure to hazardous

Session 2: Industry Specific

Session 3: Risk Assessment Case Studies

Coffee break

Introduction

This short training course will provide an overview of the substance and mixture classification approach for human health effects in accordance with GHS/CLP and will cover the differences (where they arise) between these approaches.

It is designed to be a “hands on” course where attendees will have the opportunity to put their learning into practice by means of set examples. This will help re-enforce their learning and build their confidence in classifying and labelling both substances and mixtures.

The course will cover the following:

• Introduction to GHS/CLP and why classification is important

○ Data sources and reliability

○ Harmonised classification Vs Self-classification.

○ Steps for classification of a substance and mixture

• Hazard classes (human health effects) and categories (health effects) including:

○ Acute toxicity

○ Skin corrosion/irritation

○ Serious eye damage/eye irritation

○ Respiratory or skin sensitisation

○ Germ cell mutagenicity

○ Reproductive toxicity

○ Carcinogenicity

○ Specific Target Organ Toxicity – Single Exposure (STOT-SE)

Pre-conference Training Course: TOXICOLOGY & GHS/CLP 14 February 2017, 12.00-17.00

chemicals and the corresponding health risks. Developed to assist professionals who are responsible for conducting health risk assessments and making decisions on risk management.

Dr Salmaan H Inayat-Hussain, Head Global Toxicology Group Health, Safety and Environment (GHSE), Petronas, Malaysia

16.45 Q&A

17.00 Close of conference





This course has been arranged by Chemical Watch and offers a practical introduction to regulatory safety and risk assessment. It is intended for those with either little or no knowledge of the risk assessment process.

The course offers a comprehensive coverage of the basics of risk assessment, including what it achieves and the requirements under various country-specific regulations.

Furthermore, case studies and the opportunity to put the learning into practice will be a key feature of this course.

The learning outcomes are to allow those attending to understand the key data endpoints that make up risk assessment, covering toxicity, chemistry and exposure.

Course leaders:

Laura Robinson is a qualified toxicologist and chemist with over ten years’ experience in health, safety and environmental issues, as well as chemical compliance. Laura is an accomplished toxicology trainer, consultant and author of two published books on toxicology.

Dr Peter Di Marco, is a Fellow of the Academy of Toxicological Sciences (FATS; US), President, ACTRA and President Elect, IUTOX. Peter is regulatory toxicologist with over 35 years experience in research, teaching and risk assessment.

Post- conference Practical Risk Assessment Training 16 February 2017, 08.45-16.30

Morning Session

• Background and Introduction

• Hazard identification and assessment

○ Human health data gathering

○ How to find and evaluate data for risk assessment purposes

○ The use of chemistry knowledge (i.e. structure and physicochemical properties)

○ Identification of critical studies for use in the derivation of benchmark “safe dose”

○ Worked (and group) examples throughout this section

• Exposure assessment

○ The approach which should be taken in exposure assessment and the type of models which can be used (why and how)

○ The importance of chemistry in the assessment of likely exposure routes

• Worked (and group) examples

Afternoon Session

• Risk characterisation

○ Risk perception

○ Tolerable and acceptable risk

○ Risk management

○ Risk characterisation

• Case study

Dr Jeremy Wong, Product Safety and Toxicology, The Estée Lauder Companies, Inc., USA

During this intensive training course, selected expert speakers will take participants through the concepts of risk, using practical case studies wherever possible. The day is intended for those who have basic knowledge of Risk Assessment.

○ Specific Target Organ Toxicity – Repeated Exposure (STOT-RE)

○ Carcinogenicity

○ Aspiration hazard

Who is this course suited to?

The course is suited for anyone who needs to understand the underlying principles of classification and labelling under GHS/CLP, regulatory and HSE professionals, authors and users of Safety Data Sheets, etc.

Throughout the training course worked examples will be used to illustrate the classification process and re-enforce the learning. Furthermore, the course manual will contain practice questions (with answers) for completion at the end of the course. Full lecture notes (in the form of a training manual) are included together with a copy of the presentation slides and homework.

Course leader: Laura Robinson is a qualified toxicologist and chemist with over ten years’ experience in health, safety and environmental issues, as well as chemical compliance. Laura is an accomplished toxicology trainer, consultant and author of two published books on toxicology.





Location & accomodation

Event times Pre-conference Training Course: Toxicology & GHS/CLP

14 February 2017 12:00-17:00

Toxicological Risk Assessment & Product Safety Forum 2017

15 February 2017, 08:30-17:00

Post-conference Practical Risk Assessment Training

16 February 2017, 08:45-16:30

Three ways to register

Prices

Chemical Watch subscribers

Members of Singapore Manufacturing Federation

Post-conference Practical Risk Assessment Training

USD$700

USD$700

USD$500

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www.chemicalwatch.com/Product_Safety_Forum

[email protected]

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Marina Mandarin Hotel 6 Raffles Boulevard, Marina Square, Singapore 039594 T: +65 6845 1000

We have arranged a special bedroom rate for Conference participants at the Marina Mandarin. Participants will be sent a link for booking hotel accommodation directly with the hotel.

Payment options:

• Invoice payable by bank transfer, credit card or cheque made payable to CW Research Ltd.• Online using our secure order form

Payment must be made before the event starts

+44 (0)1743 818 297t

Non-subscribers

Pre-conference Training Course: Toxicology & GHS/CLP

USD$750

USD$300

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–

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This event is supported by:

C30 M0 Y95 K0

C60 M5 Y95 K0

C0 M0 Y0 K70

C0 M50 Y100 K0

C30 M0 Y10 K0

C60 M10 Y5 K0




toxicological risk assessment & product safety forum 2017 · toxicological risk assessment...

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