REACH is now a days a common understanding – REACH has arrived and REACH will stay. REACH is a continuous process. Many companies have submitted REACH registration in 2010, in 2013 or for new substances. Many of them will be facing the upcoming 2018 deadline and for many more companies, REACH registration will be a brand new process, many of which will be SMEs (Small and Medium Enterprises).
In 2010, REACH was new for everyone: companies, authorities, testing labs. In the meantime we gathered quite some useful information to refine testing and registration strategy. In 2018, it is expected that many companies will use alternative testing methods such as QSAR and read across. Until now, those alternative testing methods have been shown to be improperly used. This webinar attempts to highlight the last development of REACH including testing strategy and tips and tricks to more efficiently and successfully use QSAR and read across in REACH registrations.
What will participants learn from this presentation?
- Creating a strategy for 2018 REACH registration
- Latest news from CEFIC and ECHA
- Tips and tricks on the use of QSAR and read across
Erwin Annys, Director REACH/Chemicals Policy, CEFIC
Erwin Annys obtained a PhD in Chemistry from the university of Ghent, where he graduated on nitrosamines in rubber. He worked sixteen years in the chemical industry in different positions in production, technical services, research and development and regulatory affairs. In 2001 with the publication of the white book, he was confronted for the first time with the new chemical legislation on chemical substances, REACH. Since then he follows this very closely and this legislation brought him to the Belgian federation of the chemical industry and the life sciences, Essenscia, in 2004 where he was responsible for product and innovation policy. Since 2008 he is working for CEFIC, the European Chemical Industry Council where he is director REACH/Chemicals policy. He is an observer in the Competent Authorities Meeting for REACH and Classification and Labeling, as well in different Committees of ECHA.
Marie-Elène Boivin, Head of Regulatory Affairs, WIL Research
Marie-Elène Boivin obtained a PhD in ecotoxicology from the Vrije Universiteit van Amsterdam, where she graduated on the diversity of microbial communities in metal-polluted heterogeneous environments. After her PhD she worked at the National Institute for Public Health and the Environment (RIVM) in Bilthoven as a risk assessor of industrial chemicals. She joined WIL Research Europe in 2006 as a Regulatory Affairs Manager. She was responsible for the registration of industrial chemicals, including advice on chemical testing and registration strategy, test study evaluation, read across, QSAR, risk assessment, PBT assessment and classification and labelling. In January 2011 she was promoted to Head of the Regulatory Affairs, leading a team of more than 20 Regulatory Affairs Managers (PhD, MSc, BSc), providing support for the registration of Pharmaceutical products and (agro)chemicals worldwide. In this role she ensures and facilitates a strong organization, high quality, planning, budget and knowledge of the Regulatory Affairs team.
Tatiana Netzeva, Senior Scientific Officer, Computational Assessment and Dissemination Unit, ECHA
Tatiana Netzeva obtained her PhD in computational chemistry and QSAR from the Faculty of Pharmacy, Medical University, Sofia. In 1994 she taught physical-chemistry at the University and had some practice as a clinical pharmacologist as well. In 2001 she obtained a post-doctoral position in the area of QSARs for environmental endpoints in the Liverpool John Moores University. There she was exposed to the concept of REACH and in 2004 moved to the European Chemicals Bureau (ex- now) as an expert in computational toxicology, QSAR, grouping of substances and read-across. During that time she experienced working with European Member States and researchers on technical issues of computational toxicology and preparing guidance for Industry under the RIP 3.3 project. She joined ECHA in 2008, where at first she was responsible for substance identification, then she moved to methodology development teams concerning computational assessment and read-across. She is involved with OECD in a number of projects, such as the Guidance on grouping, the OECD QSAR Toolbox, the OECD Chemical Cooperative program (CoCAP), and is currently on the Molecular Screening and Toxicogenomics list.
Willemien Wieland, Regulatory Affairs Manager, WIL Research
During her PhD, Willemien Wieland worked on the plant-based expression of immunoglobulins and other Pharmaceuticals for veterinary use at Wageningen University. After she obtained her PhD, she made gene constructs for the expression of human Fc Receptors, and humanized mice with these constructs at the Medical Centre in Leiden (LUMC). A second post-doc period was completed at the veterinary department of Utrecht University, where she developed methods to evaluate vaccine efficacy for autoimmune diseases. Then she made a switch and joined WIL Research Europe in 2012 as a Regulatory Affairs Manager. In this position, she is involved in the registration of industrial chemicals (REACH and global), including consultancy on chemical testing and registration strategy and dossier building, including data evaluation, read across, QSAR, PBT assessment and classification and labeling.
Who Should Attend?
VPs, Directors, and Managers in the following areas:
- Alternative testing
- Regulatory Affairs
- Product stewardship
WIL Research provides world-class research and development services for Pharmaceutical and chemical organizations. The company combines scientific expertise with an eagerness to truly listen and understand client needs. With more than 64,000 square meters of laboratory space and offices in North America, Europe and Asia, WIL Research offers extensive resources over a broad range of services. Areas of expertise include general toxicology, developmental and reproductive toxicology, juvenile toxicology, neurotoxicology, inhalation toxicology, infusion toxicology, genetic toxicology, pathology, safety pharmacology, ecotoxicology, environmental fate, immunochemistry, analytical/bioanalytical chemistry and ADME. The experts at WIL Research can also help with worldwide regulatory and compliance issues. The more than 1,100 team members, many with advanced degrees, have completed thousands of projects, often pioneering new techniques along the way. These skilled researchers use their scientific knowledge and their advanced listening skills to develop customized solutions that match the specific requirements of each project.