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  • Medical Devices | Consulting and Regulatory Compliance | CEHTRA

    Top of the page MEDICAL DEVICES Description Contact Key Services Value-added Trainings Media Patient safety is at the center of our concerns. Speed up your time-to-market is essential to fulfill this goal. Whether you are a legal manufacturer of medical devices, a subcontractor or a supplier, CEHTRA supports you throughout the life cycle of your medical device, from design to post-marketing follow-up, including CE marking. We provide our independence and expertise in biological risk assessment to demonstrate the biological safety of your device. The transversality of our expertise in sectors such as pharmaceuticals, biocides, cosmetics and chemicals (REACH) enables us to provide you with the most detailed support. Our expertise includes the Devices without an intended purpose, the borderline products Description Contact Meet our experts Pierre-Yves JOYEUX Head of Medical Devices sector pierre-yves.joyeux@cehtra.co m Imen HAMDOUNI Toxicologist imen.hamdouni@cehtra.co m Key Services Biological Safety Regulatory Support Quality Management Chemicals (REACH) To guarantee the biocompatibility of materials and substances of medical device To ensure compliance with regulatory requirements throughout the life cycle of medical devices ​ To guarantee regulatory compliance based on regulatory requirements and EN ISO 13485 To ensure that the products that are part of your processes comply with REACh regulations Biological Safety ​ ​ Assessment of the biological risk associated with a product or material Evaluation and testing within a risk management process standard (EN ISO 10993-1:2020) and the MD Regulation Review of predicates, materials, processes and components to inform manufacturer of known and potential biological and toxicological hazards and regulatory implications. Establishment of allowable limits for leachable substances (EN ISO 10993-17) Chemical characterization of medical device materials within a risk management process (EN ISO 10993-18) Recommendation of control measures to reduce risk, whether through testing or by establishing the safety of materials and processes. ​ ​ Regulatory Affairs Support ​ ​ General regulatory support: Need an answer? A problem to assess? Need advice on how to respond to the Notified Body on a biosafety issue? Crisis management support: To help to prepare or develop an effective response before or after receiving an inspection notification from the competent authority, or a warning letter. To help to prepare an effective response to Nonconformity from notified bodies Modification evaluation support: Evaluation of the impact of a modification on the biocompatibility of the material/medical device Mentoring to assist the manufacturer in the characterization of the modification ​ ​ Quality Management ​ ​ Internal audits : Based on Quality management system standard (ISO 13485) & MDR ​ Mentoring: To assist on set up a QMS, we make ourselves available to challenge your system. ​ PRRC ( Person responsible for regulatory compliance ) Possible to externalize this function for specific SMEs manufacturers ​ Chemicals (REACH) ​ ​ Registration of chemical substances to meet the requirements of the REACh regulation Authorization: prohibited substances for which an authorization of use can be set up Monitoring of hazardous substances (SVHC, restricted substances, endocrine disruptors,...) Your tailormade Safety Data Sheets (SDS) Value-added Services Global and transversal approach Data and bibliographic analysis for Biological Safety High level of expertise in toxicology and medical device kept up to date (ISO/EN) Training: Regulatory Affairs, Biological Safety, standardization Independence from labs Benefit/risk Evaluation Trainings Coming soon Biological evaluation of medical devices in accordance with EN ISO 10993-1 en savoir plus s'inscrire Key Services Value-added Trainings Media Media Flyers Related Sectors Pharmaceuticals Chemicals (REACH) Cosmetics Biocides Haut de page

  • Safer cosmetics for tomorrow - Know your regulatory obligations

    Safer cosmetics for tomorrow - Know your regulatory obligations En savoir plus Training > Safer cosmetics for tomorrow - Know your regulatory obligations Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations Programme Part 1 - Regulatory context for cosmetic products (Europe and other countries) European Cosmetics Regulation n° 1223/2009 - Scope / Borderline products - Cosmetovigilance - Management of updates Part 2 - Cosmetic product safety report - Notion of safety assessment: MoS calculation, local tolerance, etc. - Toxicological profiles of ingredients Part 3 - Specific cases - Baby products, perfumes - In silico Part 4 - Q&A I Assessment of knowledge acquired through a final quiz Méthodes mobilisées The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience R&D, Regulatory, Quality, Safety Assessors, Manufacturers, Distributors, Subcontractors, Suppliers, Importers. Prérequis Cosmetics regulatory affairs officer or toxicologist. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne Coming soon Délais d'accès : 3 mois Clarisse Bavoux Head of Cosmetics ​ 2021 « Formation complétement adaptée à mes besoins, Clarisse Bavoux à l'écoute et très clair dans ses explications. Merci pour cette formation qui me sera fort utile au quotidien. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment

    Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment En savoir plus Training > Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification & Labelling and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them Programme Part 1 - Environmental data Reminder of useful physico-chemical parameters Abiotic degradation studies Biotic degradation studies Part 2 - Ecotoxicology Organisms used in regulatory ecotoxicology Ecotoxicology studies: methods Principle of studies: critical parameters Alternative non-experimental methods used in ecotoxicology Part 3 - Regulatory use of data PBT and POP assessment Risk assessment: Principle and derivation of PNECs from ecotoxicology studies Classification SDS Part 4 - Q&A I Assessment of knowledge acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. English-language support material will be provided to trainees. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Scientists and Regulatory Affairs Managers. Prérequis Bac +2. Chat Chat 10h30 Location Chat Chat from 870€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 08.04.24 to 09.04.24 06.06.24 to 07.06.24 Délais d'accès : 3 mois Blandine Journel Senior Ecotoxicologist ​ 2023 « Une formation de qualité, très bien construite qui m'a permis de rafraichir mes connaissances, certains point ont pu même être mis en pratique/vérifier dès le lendemain sur mes dossiers ! Merci » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Plant Protection Products: from regulation to registration

    Plant Protection Products: from regulation to registration En savoir plus Training > Plant Protection Products: from regulation to registration Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Programme Part 1 - Regulation (EC) No 1107/2009 The main points The different procedures involved Part 2 - Zonal assessment Zonal assessment: North, Centre and South zones: similarities and differences Exchanges between the Notifier and the Competent Authorities Part 3 - Requirements - The Dossier New requirements: for which substances? for which products? Bringing an existing dossier into line with the new regulatory requirements Part 4 - Case studies Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Regulatory Affairs Officer in charge of Products/Active Substances. Prérequis Scientific background. Beginner in regulatory affairs for plant protection products. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 06.06.24 03.10.24 Délais d'accès : 3 mois Estelle Beltran Head of Plant Protection Products ​ 2020 « Je vais la conseiller à mes proches collaborateurs. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Les Fondamentaux - Formations | CEHTRA Training

    THE BASICS Learn and keep up to date on the essentials of the regulations. Discover Training > Fondamentaux > Ancre 1 BIOCIDES COSMETICS ECOTOXICOLOGY MEDICAL DEVICES PACKAGING PLANT PROTECTION REACH TOXICOLOGY Biological evaluation of medical devices in accordance with EN ISO 10993-1 from 580€ (HT) Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Voir les sessions Familiarise yourself with eSDS: obligations, content and compliance from 580€ (HT) Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS Voir les sessions How do Biocidal Product Families work? Accelerate your time to market! from 580€ (HT) Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations Voir les sessions Introduction to packaging regulations: understanding and implementing them from 580€ (HT) Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Voir les sessions Master CHESAR to simplify your REACH assessments from 580€ (HT) Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations Voir les sessions Master IUCLID and register your substances under REACH from 290€ (HT) How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Voir les sessions Plant Protection Products: from regulation to registration from 580€ (HT) Understanding regulatory procedures for active substances and products Understanding zonal assessment and dRR dossiers Understanding the content of dossiers and the pitfalls to avoid Voir les sessions Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics from 140€ (HT) Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. Voir les sessions Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment from 870€ (HT) Gain a better understanding of why studies are carried out, what the results mean and how they can be used for Classification & Labelling and Risk Assessment. Be able to spot the pitfalls of studies and know how to avoid them Voir les sessions Safer cosmetics for tomorrow - Know your regulatory obligations from 580€ (HT) Knowing and understanding Cosmetics Regulation 1223/2009 Understand the risk assessment of a cosmetic product Identify areas for improvement in order to comply with regulatory obligations Voir les sessions Toxicology and Classification - the fundamentals of your regulatory success from 1160€ (HT) Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts Voir les sessions 2023 « Formation très claire avec formatrice très agréable. Les exemples concrets ont permis de mettre en lumière la complexité des packagings et d'obtenir des informations sur la composition. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics

    Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics En savoir plus Training > Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Be able to describe the basics of European regulation 2022/1616/EC for recycled plastics in contact with foodstuffs Be able to describe the basics of US regulations for recycled plastics: No Objection Letters, processes, etc. Programme Part 1 - Regulation 2022/1616/EC - Recycled plastic articles Part 2 - FDA - No Objection Letter (NOL) - recycled plastic articles Part 3 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based on a presentation with role-playing exercises and ongoing interaction with the expert. The support material will be given to the trainees. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 8. Our courses are delivered through synchronous learning. Public Audience Players in the food and cosmetics packaging industry. Prérequis None. Chat Chat 1h30 Location Chat Chat from 140€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 19.03.24 18.06.24 Délais d'accès : 3 mois Caroline Optiz Head of Packaging ​ ​ ​ La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Pharmaceuticals - Regulatory Compliance | CEHTRA

    Top of the page PHARMACEUTICALS (Human & Veterinary) Description Contact Key Services Value-added ERA Trainings Media For the safety of your pharmaceutical and veterinary substances & products CEHTRA can assist you with: Safety of your drug substances and drug products: development and regulatory submissions. Safety of your drug production (PDE, OEL/OEB, impurities qualification) Generation of Environmental Risk Assessment (ERA) for your MAA dossier Description Trainings Meet our experts Stephane PIERRE Head of Pharmaceuticals stephane.pierre@cehtra.com Blandine JOURNEL Senior Ecotoxicologist, ERA blandine.journel@cehtra.com Key Services PDE and OEL/OEB Calculations Safety Qualification of Impurities Safety assessment of drug production and workers on site (PDE, OEL/OEB) Safety qualification of impurities in drug substances or products (ICH and VICH guidelines) Preclinical Expertise Development plan, study monitoring, writing regulatory dossiers (CTA, MAA...) Environmental Risk Assessment Entire ERA part of the MAA is covered (dossier preparation, study monitoring, defense with authorities…) Value-added Services Trainings QSAR support using Nexus DEREK and Leadscope Data and bibliographic analysis Toxicologist and Ecotoxicologist team (as well as QSAR expert) Dossier Defense Regulatory Watch Contact Key Services Value-added Related Trainings 19 March. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire Media Videos Flyers Media Related Sectors Biocides Chemicals (REACH) Cosmetics Industrial Hygiene Packaging Haut de page

  • Trainings | CEHTRA Training

    CEHTRA Training Deepen your knowledge with our expertise. Find the right course for you among our programmes. Discover Nos programmes Our programmes Regular training is essential to keep abreast of regulatory changes. Choose the formula that suits your needs. THE BASICS Learn and keep up to date on the essentials of the regulations. Discover MENTORING Tailor-made training to meet the specific challenges of your company. Discover All our courses can be adapted for people with disabilities. What our customers say "I am very satisfied with this course, which was well adapted to my background and met my needs. Furthermore, the distance learning format is entirely satisfactory, and the limited number of trainees facilitates exchanges." La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. About CEHTRA We have been specialising for 20 years in assisting companies in the marketing of chemical substances or products in France and also in Europe and outside Europe. Our toxicologists, ecotoxicologists and chemists provide you with their expertise to ensure the regulatory compliance of your products. With a team of 70 people, we cover a dozen sectors including REACH, biocides, plant protection products, etc... +

  • Biocidal Products - Regulatory Compliance | CEHTRA

    Top of the page BIOCIDES Description Description Contact Key Services Value-added Trainings Consortia Media Among others, are yo u required to: ​ Deal with an Active Substance dossier (new or renewal)? Submit a single product or BPF dossier? Apply for Article 95 List inclusion or for Technical Equivalence or for any request related to BPR? ​ Our broad experience in supporting active substances and biocidal products is your best guarantee. Among the multiple uses covered by Biocidal Product Regulation (EU) 528/2012 (BPR), which one is yours: ​ Disinfectants? Wood pr eservatives? Pest control (Rodenticides, Insecticides, Repellents, ...) ? Antifouling products? ​ Entrust your dossi er into experi enced hands! Contact Meet our experts Nathalie HANON Head of Biocides nathalie.hanon@cehtra.com Cyril DUROU Senior Ecotoxicologist cyril.durou@cehtra.com Annekathrin FAUPEL Senior Regulatory Manager annekathrin.faupel@cehtra.com Key Services Value-added Services Key Services Biocidal Product Single Product Biocide Products Family EU R&D Notifications Active Substance New active substance Renewal of Active Substances approval Annex I inclusion Article 95 Listing Dossier Preparation Testing strategy Study Monitoring Alternatives to in vivo testing Consortia Management Consortia containing specific active substances CEHTRA's consultants has been involved in the preparation of several active substances Annex I inclusion dossiers and submission of biocidal products through the BPR process and under National schemes. ​ Our team has also successfully completed many Biocide Product Registration and Biocide Products Family dossiers from start to finish without counting the numerous projects for regulatory support, Monitoring, Outdoor Operator Exposure Studies, Expert Advice and Position Papers. Media Videos Flyers Consortia QuAC (Biocides) Trainings Coming soon How do Biocidal Product Families work? Accelerate your time to market! en savoir plus s'inscrire 8 April. 2024 Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment en savoir plus s'inscrire Trainings Value-added Services Assessment of ED properties Negotiations with Authorities Risk Assessment and Modelling Technical Equivalence Data Sharing Negotiations Consortia Media Haut de page

  • Cosmetics - Regulatory and Toxicological Expertise | CEHTRA

    Top of the page COSMETICS Cosmetick Contact Key Services CPSR Ecotoxicology Value-added Trainings Media Our Tools Check out if toxicological and eco-toxicological profiles for your ingredients of interest are covered in Cosmetick! Search profiles Tools Contact Key contacts Clarisse BAVOUX Head of Cosmetics clarisse.bavoux@cehtra.com Marlène BARON Toxicologist marlene.baron@cehtra.com Sandrine MORICHON Regulatory Aff airs Specialist sandrine.morichon@cehtra.com Key Services Cosmetic products & formulations : safety, ecotoxicology, expert advice and regulatory reports Pre-assessment Cosmetic Product Safety Reports (CPSR) Ingredients, Raw Materials : Toxicity, Ecotoxicity and Maximum Doses Toxicological profiles Ecotoxicological profiles Identification of safe concentrations for cosmetic uses Ingredients under development: strategy, dossier (toxicology and ecotoxicology) Support for toxicological and ecotoxicological issues Testing strategy In silico approach Additional data Final dossier Literature search, bibliography In vitro tests: analysis and advice Management of da ta gaps by alternative methods (Read-Across, in silico approach) Key Services CEHTRA has been commissioned by numerous companies including multi-nationals in the cosmetics industry to assist them with cosmetic regulation compliance. ​ CEHTRA evaluates the safety of several types of products (care, hygiene, perfumes...), and new ingredients. Cosmetick includes comprehensive databases allow us to anticipate risks for your products. ​ We can propose complementary approaches in case of data gaps (structural alerts, QSAR, Read-across). Our eco-toxicologists can contribute to the eco-conceptions of your formula. ​ At CEHTRA, we are professional partner of the Cosmetic Valley and provide different training courses on the Fundamentals of the Cosmetic Regulation, webinars on Content / Container Interactions or seminaire in University. "COSMETICK Advanced is a very useful tool for any cosmetic products safety assessor : all required data are gathered (very complete toxicological profils but also ecotoxicity data and regulation alerts). The tool can be used to assess the systemic risk of products ingredients and impurities. It also provides local tolerance alerts. It is very easy to use and a great help when you start working on a new project." Ecoxotoxicology Services and Tools in Ecotoxicology ​CEHTRA is committed to the protection of the environment, and offers services and tools in ecotoxicology: ​ COSMETICK is an online software solution offering ecotoxicological profiles and an "Ecotoxicological Alerts" system for ingredients and formulas ​ ECOSCORES can be customised to score and measure the ecotoxicological and environmental footprint of cosmetic products ​ ECOTOXICOLOGICAL EVALUATIONS of ingredients and formulas allow prioritisation of ingredient choices up to the obtaining of Labels such as the EU ECOLABEL (rinsed and non-rinsed cosmetic products) ​ MISSING DATA can be replaced in part by results from alternative methods (Read-Across, in silico approaches) ​ Our ADVICE and REGULATORY support enable us to ensure the compliance of your products and ingredients, manage risks and anticipate regulatory changes. Key contact Pierre-Yves GOURVES Ecotoxicologist pierre-yves.gourves@cehtra.com Value-added Services In-depth expertise for INCI, impurities and fragrance components, including MOS and QRA Hazard assessment (toxicology and ecotoxicology) Extensive and cross-cutting areas of expertise: from environment to human health, from formulation to packaging Data qualification Monitoring of studies Cosmetick database (toxicological & ecotoxicological profiles, formula analysis) Trainings 19 March. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire 26 March. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Media Flyers Value-added Services Trainings Media Related Sectors Our Partners Packaging Haut de page

  • Regulatory expertise - Plant Protection and Health | CEHTRA

    Top of the page Description PLANT PROTECTION Description Contact Key Services Biocontrol Value-added Trainings Media As a manufacturer or a distributor in the field of agriculture, you want to get your substances approved efficiently and get your Plant Protection Products on the market. From Data Gap Analysis through to the dossier submission to the competent authorities, CEHTRA's team supports you in the necessary steps to meet the current regulatory requirements, for a successful registration. Contact Meet our experts Estelle BELTRAN Head of Plant Protection estelle.beltran@cehtra.com Blandine JOURNEL Expert Ecotoxicologist blandine.journel@cehtra.com Key Services Value-added Key Services Regulatory Dossiers From registration strategy up to the post-submission defense Data Gap Analysis Testing proposal Study monitoring Hazard identification Scientific rationale Risk Assessment Toxicology Consumer Environment Ecotox Modelling and refinement Task Force Management Management support to facilitate joint applications in the EU and abroad Value-added Services Endocrine Disrupting Properties CADDY and IUCLID dossiers Biocontrol Diagnostic Fertilizers and Biostimulants Environmental Screening Tailored studies (operator, field) Authorization of formulated products (including North and South America) Trainings Trainings 6 June. 2024 Plant Protection Products: from regulation to registration en savoir plus s'inscrire 8 April. 2024 Regulatory ecotoxicology: from the appropriate conduct of studies to environmental risk assessment en savoir plus s'inscrire Media Flyers Media Haut de page

  • Regulatory affairs - Packaging compliance | CEHTRA

    Top of the page PACKAGING Description Contact Key Services Value-added Trainings Media As a manufacturer, user of packaging or supplier for packaging manufacturing, you are facing regulatory issues? ​ For the safety of your packaging substances & products, our team of expert with over a decade of experience can assist you with : ​ Study of your documentation: declaration of compliance, regulatory statements Compliance of restricted substances thanks to an internal tool using mathematic modeling Monitoring of analysis with external laboratories Evaluation of worldwide regulatory requirements​ for packaging Click here to learn more... New ! Stay Ahead of Substance Migration with SF PP3 and CEHTRAPACK Tools ! Description Contact Meet our expert Caroline Opitz Head of Packaging caroline.opitz@cehtra.com Stephane PIERRE Managing Director of Paris Agency stephane.pierre@cehtra.com Key Services Regulatory / safety watch Customized text list Toxicological and regulatory substance watch Mapping by material / geographical area Regulatory / safety support Collection of supplier data Specifications Declarations of conformity Specific topics Global support Conduct of laboratory tests Multi-market support Food Pharmaceutica Medical Cosmetics Migration modeling Interactions between packaging and contained products: cosmetics and food By calculation By mathematical modeling Risk assessment of various materials : plastics, papers and boards, adhesives, inks, varnishes, metals, glass… Regulatory support on international regulations relative to food contact : EU, USA, Switzerland, China, Mercosur… Editing regulatory specifications and collecting informations from suppliers, documentary diagnosis, help in creation of Declaration of Compliance Compliance of restricted substances thanks to an internal tool using mathematic modeling, advices and monitoring of external lab tests when necessary Pragmatic approach to avoid expensive migration or extraction testsExpertise toxicologique Toxicological expertise Food contact courses We adapt our offer to the customer’s need Key Services Value-added Value-added Services Training offer Regulatory watch Regulatory and toxicological support Dedicated suppor t Packaging data management Migration / release assessment tools Trainings Trainings 19 March. 2024 Regulations in Europe and the USA for recycled plastics intended for contact with food and in cosmetics en savoir plus s'inscrire 26 March. 2024 Introduction to packaging regulations: understanding and implementing them en savoir plus s'inscrire Media Flyers Media Related Sectors Cosmetics Industrial Hygiene Haut de page

  • Introduction to packaging regulations: understanding and implementing them

    Introduction to packaging regulations: understanding and implementing them En savoir plus Training > Introduction to packaging regulations: understanding and implementing them Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Areas: food contact, cosmetics and pharmaceuticals Understand the regulatory prerequisites for cosmetic, food contact and pharmaceutical packaging Acquire an overview of the regulatory texts applicable to materials Be familiar with the essential requirements and specific features of this legislation Understand a container/content risk assessment (LMS) Programme Part 1 - Regulatory requirements for cosmetic packaging Part 2 - Regulatory requirements for food contact packaging Part 3 - Migration principles (container-content interactions) Part 4 - Regulatory requirements for pharmaceutical packaging Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Regulatory, Technical and Quality positions. Prérequis None. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 26.03.24 14.05.24 Délais d'accès : 3 mois Caroline Optiz Head of Packaging ​ 2023 « Très intéressantes, cette formation a permis de remettre en place les bases réglementaires au sujet des packagings. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Toxicology and Classification - the fundamentals of your regulatory success

    Toxicology and Classification - the fundamentals of your regulatory success En savoir plus Training > Toxicology and Classification - the fundamentals of your regulatory success Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understand the role of toxicology in the life of substances in accordance with regulations Understanding the main tests, their difficulties and the issues involved Optimising interaction between managers and experts Programme Part 1 - Regulatory toxicology ? General information Part 2 - ADME (Absorption, Distribution, Metabolism, Excretion): concepts Part 3 - Acute systemic toxicology (oral, cutaneous, inhalation) Part 4 - Local skin and eye tolerance Part 5 - Skin sensitisation Part 6 - Repeated-dose and chronic toxicity Part 7 - Reproductive and developmental toxicity Part 8 - Mutagenicity and genotoxicity - Classification Part 9 - Carcinogenesis Part 10 - Introduction to non-experimental alternative methods used in toxicology Part 11 - Introduction to the determination of Toxicological Reference Values Part 12 - Introduction to human health risk assessment Part 13 - Toxicology described through a regulatory dossier (REACH) - case study Part 14 - Assessment of knowledge through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Employees involved in product safety. Prérequis None. Chat Chat 14 hours Location Chat Chat from 1160€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 20.06.24 to 21.06.24 17.10.24 to 18.10.24 Délais d'accès : 3 mois Nathalie Mayer Toxicologist ​ 2022 « Très satisfaite de cette formation qui même si elle ne traite pas du Dispositif médicale, traite le sujet de toxicologie de façon suffisamment large tout en étant accessible. La vision est très globale est c'est ce que je recherchais. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • REACH compliance : registration of chemicals | CEHTRA

    Top of the page CHEMICALS (REACH) Description Contact Key Services REACH dossier Value-added Trainings Media A solid, highly experienced team focused on helping you meet your compliance deadline. You're in safe hands. A solid REACH dossier will enable you to put your substance on the market serenely. Your product is your priority, you are ours. During REACH Phase 1, 2 & 3 CEHTRA provided high quality technical and regulatory support and obtained extensive experience which can be a real asset to industry faced with the challenge of managing, completing and updating dossiers. ​ Moreover, by implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. Click here to read more about how CEHTRA experts can assist you with REACH registration dossier updates. Description Contact Meet our experts Mathieu ROLLAND Head of REACH mathieu.rolland@cehtra.com Brigitte CASENAVE Senior Chemist brigitte.casenave@cehtra.com Key Services Key Services Dossier compilation & update Lead registrant and co -registrant dossiers testing strategy SIEF Management Only Representative Supply-chain management Consortium and SIEF communication, administrative and financial management of LoA Representation of non-EU companies through our Only-Representative (OR) Legal Entity and UK-REACH Obligations as EU importer, manufacturer or Downstream-User (DU) Notifications to ECHA CEHTRA's consultants have been involved in the preparation of hundreds of REACH registration dossiers, acting on behalf of either the Lead Registrant or a coregistrant. ​ Industrials have successfully experienced CEHTRA and they continue for reviewing their product portfolio and strategy for REACH registration of substances, adapting testing strategies, expert regulatory and scientific advices. REACH dossier registration updates Implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. ​ The requirement to update ‘without undue delay’ is in most cases specified as three months and, in more complex cases, up to 12 months. ​ Additionally, Cefic, through its multi-annual Action Plan, provides a framework for REACH registrants to evaluate the safety data in a stepwise manner. IUCLID Migration Dossier Review Lead Registration dossier update Co-registration dossier update TCC passing for dossiers submitted in older versions of IUCLID 6 Full update for IUCLID 5 dossiers Listing vulnerabilities and corrective actions Expert advice to tackle them Boundary composition including all SIEF information Outcomes associated to new studies CSR with CHESAR New UVCB qualities New impurity profile Impact for C&L Tonnage update We have indeed a large amount of experience in the update process: i) IUCLID Migration Services ​ Only by using the Technical Completeness Check (TCC) tool in the latest version of IUCLID (6.5.1.2) can you ensure your submission will pass the first submission processing steps in REACH IT. ​ IUCLID 5.6 and newer files can be imported directly into the latest version of IUCLID (6.5.1.2) however they will most likely fail the latest Technical Completeness Check (TCC) and therefore need updating. Any IUCLID files older that 5.6 will not import into the latest IUCLID directly and would need to be updated in a stepwise process. ​ If you need to make submissions to the UK competent authority after Brexit you will also need to pass the latest TCC check. ​ Our team has good experience with IUCLID migration services. If you have any questions, write to one of our experts or simply drop your query in the chat window below and one of our experts will get back to you. ​ ii) Joint Submission Services ​ CEHTRA experts accompany: Companies to update their dossier within or without the CEFIC Action Plan ​ Lead Registrants for preparing the dossier updates and associated costs taking other SIEF members into consideration. ​ Co-registrants when supply-chain and/or composition has been modified. Chemicals (REACH) - Dossier update Value-added Services Trainings Value-added Services Cost-sharing and data-sharing UVCB registration Alternative testing strategies Expert advice Study monitoring PRIMO tool to optimize management and follow-up of data Trainings 4 June. 2024 Master CHESAR to simplify your REACH assessments en savoir plus s'inscrire 18 June. 2024 Familiarise yourself with eSDS: obligations, content and compliance en savoir plus s'inscrire Coming soon Master IUCLID and register your substances under REACH en savoir plus s'inscrire Media Related Sectors Global Notifications Industrial Hygiene REACH Authorisation Haut de page

  • The basics - Training | CEHTRA Training

    TRAINING THE BASICS Learn and stay up to date on the essentials of the regulations. Discover Training > The basics > Ancre 1 BIOCIDES COSMETICS PACKAGING PLANT PROTECTION REACH ECOTOXICOLOGY Toxicology and Classification - the fundamentals of your regulatory success From 1160€ Understand the place of toxicology in the life of substances according to the regulations Knowing the main tests, their difficulties, their stakes Optimise the interaction between managers and experts more information Plant Protection Products: from regulation to registration From 580€ Understand the regulatory procedures for active substances and for products Understand zonal evaluation and dRR dossiers Understand the content of the dossiers and the pitfalls to avoid more information Master IUCLID and register your substances under REACH From 290€ How to navigate and enter data in IUCLID Know the main non-technical sections for a REACH dossier and how to fill them in Be able to review the technical sections of a REACH dossier Know how to use the different functionalities of IUCLID (exports, validation wizards) Know how to submit a dossier in REACH IT more information Master CHESAR to simplify your REACH evaluations From 580€ Know the obligations under REACH Know how to use CHESAR to perform a CSA (Chemical Safety Assessment) Know how to generate a CSR (Chemical Safety Report) under CHESAR To be in compliance with ECHA expectations more information Familiarise yourself with SDSe: obligations, content and compliance From 580€ Know the obligations under REACH and the impacts/sanctions in case of non-compliance Know how to construct an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Know the methods of compliance in case of discrepancies between the downstream uses and the exposure scenarios covered by the eSDS more information Regulatory Ecotoxicology: From appropriate study conduct to environmental risk assessment From 870€ Better understand why studies are carried out, what the results mean and how they can be used for Classification & Labelling and Risk Assessment Be able to spot study pitfalls and know how to avoid them more information Safer cosmetics for tomorrow - Know your regulatory obligations From 580€ Know and understand the Cosmetic Regulation n°1223/2009 Understand the risk assessment of a cosmetic product Identify the points of improvement to comply with regulatory obligations more information How do Biocidal Product Families work? Accelerate your time to market! From 580€ Understand the regulatory obligations of the different actors involved in authorising the marketing of a biocidal product more information Parole de client « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • REACH authorisation | Advice and Regulatory Support | CEHTRA

    Top of the page REACH AUTHORISATION Description Contact Key Services Value-added Trainings Media REACH Authorisation is a European risk management measure which aims to limit human and environmental exposure to substances considered of very high concern. All the users in terms of REACH definition (formulators, importers, downstream users) of one of the Annex XIV substances in Europe must carry out an Authorisation dossier to continue to be able to use the substance in question. CEHTRA's team is experienced and the entire dossier is done in-house, from the exposure estimation to the assessment of socio-economic impacts. Meet our expert Stephane PIERRE Head of REACH Authorisation stephane.pierre@cehtra.com Description Contact Key Services Key Services Complete Authorisation dossier Drafting the whole dossier in coherence (CSR, AoA, SEA) Advocacy Protect your interest (regulatory watch, supply chain securisation, public consultation...) Conformity Toward the Authorisation or restriction obligation Prioritisation/ Anticipation Anticipate the regulatory obligation based on the hazard for your substance portfolio Value-added Services All the dossier parts are performed internally Several dossier submitted with success Member of the NerSAP(Network of REACH SEA and Analysis of Alternatives practitioners) Tox / Ecotox hazard assessment based on SVHC properties Regulatory scoring based on the supporting information Draft the Analysis of Alternatives based on client’s data Value-added Trainings Trainings 4 June. 2024 Master CHESAR to simplify your REACH assessments en savoir plus s'inscrire 18 June. 2024 Familiarise yourself with eSDS: obligations, content and compliance en savoir plus s'inscrire Coming soon Master IUCLID and register your substances under REACH en savoir plus s'inscrire Media Flyers Podcasts Media Related Sectors Chemicals (REACH) Haut de page

  • Biological evaluation of medical devices in accordance with EN ISO 10993-1

    Biological evaluation of medical devices in accordance with EN ISO 10993-1 En savoir plus Training > Biological evaluation of medical devices in accordance with EN ISO 10993-1 Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understand the methodology of biological assessment in accordance with EN ISO 10993-1 Assess the conformity of a biological assessment plan Programme Part 1 - Context of the standard in European regulations Part 2 - The fundamental principles of the ISO 10993 series Part 3 - Biological assessment using the methodology of EN ISO 13993-1 Part 4 - Case study to conclude on the conformity of the proposed biological assessment plan Part 5 - Evaluation by questionnaire Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will receive a handout. A final quiz will validate what has been learnt. To enhance online learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience DM players. Quality managers. Functions responsible for compiling technical documentation. Prérequis Knowledge of medical device risk classes, the EU certification process as presented in Regulation 2017/745. General knowledge of issues relating to the biocompatibility of healthcare products. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne Coming soon Délais d'accès : 3 mois Imen Hamdouni Toxicologist ​ ​ « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Industrial Hygiene - Advice and Regulatory Support | CEHTRA

    Top of the page INDUSTRIAL HYGIENE Description Contact Key Services Value-added Trainings Media CEHTRA's industrial hygienists have decades of experience working with clients in their industrial sites and manage Environmental, Health and Safety challenges with a well balanced mix of technical expertise and practical experience. CEHTRA's track record in multi-disciplinary risk assessment and modelling applies well to real world situations involving chemical substances: ever since its creation, CEHTRA has designed and conducted EHS audits, and advised management at countless sites in virtually every sector of the chemical industry and services. Click here to learn more... New ! Quickly assess your level of compliance with Chrome VI handling Description Contact Meet our experts Guillaume MOUSSETTE Head of Industrial Hygiene guillaume.moussette@cehtra.com Stephane PIERRE Managing Director of Paris Agency stephane.pierre@cehtra.com Key Services Exposure Scenarios Specific characterisation of the risk linked to the handling of the chemical agent with CHESAR and other tools Chemical safety Reports ​ Refining approaches used in the CSR to guarantee safe use and worker protection On-site audits Ensure compliance with eSDS or authorization / restriction requirements (Operating Conditions and Risk Management Measures) On-site consulting service General Chemical risk management (HSE) Chemical agents are classified according to their hazard level. An inventory of the uses of the chemical agents feeds the exposure assessments via Exposure Scenarios, which enables the characteriation of the risk linked to the handling of the chemical agent. We base our evaluation on the Exposure Scenarios written in the Chemical Safety Report and the Safety Data Sheets that will accompany the chemical agent on the Downstream Users premises. Key Services Value-added Value-added Services Exposure and health risks at your working stations Digital dashboard Training modules for specific company needs Trainings Trainings 18 June. 2024 Familiarise yourself with eSDS: obligations, content and compliance en savoir plus s'inscrire Media Flyers Media Related Sectors Chemicals (REACH) Global Notifications REACH Authorisation Haut de page

  • Master CHESAR to simplify your REACH assessments

    Master CHESAR to simplify your REACH assessments En savoir plus Training > Master CHESAR to simplify your REACH assessments Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understand the obligations under REACH How to use CHESAR to carry out a CSA (Chemical Safety Assessment) Be able to generate a CSR (Chemical Safety Report) under CHESAR Comply with ECHA expectations Programme Part 1 - Obligations under REACH with regard to CSR Part 2 - Definition and construction stages of the CSA Part 3 - Occupational risk assessment Part 4 - Consumer risk assessment Part 5 - Environmental risk assessment Part 6 - Creation of the complete CSR and compliance with ECHA controls Part 7 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience People working on REACH regulations: - Regulatory affairs officer - Toxicologist - Ecotoxicologist - QHSE Prérequis Notions on REACH regulations. Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 04.06.24 08.10.24 Délais d'accès : 3 mois Anna Chelle Expologist and regulatory toxicologist ​ 2022 « Très bien. Informations très utiles. Je vais me servir des slides comme support dans mon travail quotidien. Anna a été très claire et a su répondre à nos questions. Elle s'est également adaptée à nos besoins et s'est concentrée sur les points les plus pertinents pour nous. Un grand merci ! » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Familiarise yourself with eSDS: obligations, content and compliance

    Familiarise yourself with eSDS: obligations, content and compliance En savoir plus Training > Familiarise yourself with eSDS: obligations, content and compliance Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Understand the obligations under REACH and the impact/penalties in the event of non-compliance Know how to draw up an extended safety data sheet As a downstream user, know how to check your own compliance with supplier SDSs Be familiar with the methods for ensuring compliance in the event of discrepancies between downstream uses and the exposure scenarios covered by the eSDS Programme Part 1 - Actors in the supply chain Part 2 - Obligation of eSDS producers under REACH Part 3 - Key stages in the construction of the CSA/CSR Part 4 - Construction of an extended safety data sheet Part 5 - Stages on receipt of a supplier SDS: compliance objective Part 6 - Impacts/sanctions in the event of non-compliance Part 7 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience People working under the REACH Regulation: - QHSE - manufacturers, formulators, chemical product manufacturers Prérequis Notions on REACH regulations. Notions on SDS (sections 1-16). Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne 18.06.24 22.10.24 Délais d'accès : 3 mois Anna Chelle Expologist and regulatory toxicologist ​ ​ « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • How do Biocidal Product Families work? Accelerate your time to market!

    How do Biocidal Product Families work? Accelerate your time to market! En savoir plus Training > How do Biocidal Product Families work? Accelerate your time to market! Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes Addressing the stages of an application for authorisation of a family of biocidal products : - Similarity of composition & grouping of co-formulants - Similarity of uses - Similar level of risk and efficacy Addressing the various points to be taken into account when dividing biocidal product families for current evaluations Programme Partie 1 - Evaluation de la similarité - Assessment of similarity : - Similarité de la composition et regroupement des coformulants - Similarité des utilisations - Similitude du niveau de risque et d'efficacité Partie 2 - Division des familles de produits biocides pour les évaluations en cours - Splitting of families for on-going applications Partie 3 - 'Best practices' pour les reunions de pré-soumission - Best practices for pre-submission meeting Partie 4 - Evaluation des acquis au travers d'un quizz final Méthodes mobilisées The course is based on a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Anyone concerned by the regulations governing biocidal products. Prérequis Review the GMP guide before the training course (CA-July19-Doc.4.2-Final -Guidance note on GMP concept_rev2). Chat Chat 7 hours Location Chat Chat from 580€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne Coming soon Délais d'accès : 3 mois Nathalie Hanon Head of Biocides ​ ​ « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • Master IUCLID and register your substances under REACH

    Master IUCLID and register your substances under REACH En savoir plus Training > Master IUCLID and register your substances under REACH Fondamentaux > Ancre 1 Overview Objectifs I Compétences et Aptitudes How to navigate and enter data in IUCLID Be familiar with the main non-technical sections of a REACH dossier and know how to complete them Be able to proofread the technical sections of a REACH dossier Know how to use the various features of IUCLID (exports, validation wizards) Be able to submit a dossier in REACH IT Programme Part 1 - Introduction to IUCLID 6.5 Part 2 - Preparing an IUCLID file: company-specific section, technical sections, Chesar-IUCLID interaction Part 3 - Validation Wizard and plug-ins? IUCLID Part 4 - Dossier creation and submission on REACH IT Part 5 - Q&A I Assessment of skills acquired through a final quiz Méthodes mobilisées The course is based around a presentation containing case studies, role-playing exercises and ongoing interaction with the expert. Trainees will be given the course material. A final quiz will validate what has been learnt. To enhance e-learning, our courses are run in small groups, from a minimum of three people to a maximum of 6. Our courses are delivered through synchronous learning. Public Audience Any user of IUCLID 6 to prepare and/or submit REACH dossiers. Prérequis Access to IUCLID. Be familiar with the REACH regulation and its requirements. Chat Chat 3h30 Location Chat Chat from 290€ (HT) French S'inscrire Chat Il est possible de planifier la formation en mode présentiel sur demande. Demande d'information Chat Fiche catalogue En Ligne Coming soon Délais d'accès : 3 mois Nathalie Mayer Toxicologist ​ ​ « Je suis très satisfaite de cette formation bien adaptée à mon background et qui a bien répondu à mes besoins. Par ailleurs, le format à distance est entièrement satisfaisant, et nombre de stagiaires limité facilite les échanges. » La certification qualité a été délivrée au titre de la catégorie d’action suivante : ACTION DE FORMATION. A propos de CEHTRA Nous sommes spécialisés depuis 20 ans dans l’accompagnement des entreprises pour la mise sur le marché de substances ou produits chimiques en France et également en Europe, et hors Europe. ​ Nos toxicologues, écotoxicologues, chimistes mettent à votre disposition leur expertise pour assurer la conformité réglementaire de vos produits. ​ Avec une équipe de 70 personnes, nous couvrons une dizaine de secteurs dont REACH, les biocides, les produits phytosanitaires… +

  • CEHTRA - Your Specialities Our Expertise | Regulatory Affairs | France

    Your Specialties, Our Expertise CEHTRA (Consultancy for Environmental & Human Toxicology and Risk Assessment) is a company of social and solidarity economy (entreprise de l’économie sociale et solidaire), the French leader and number 3 worldwide in technical assistance and regulatory, toxicological and ecotoxicological consulting for the sectors related to the chemicals industry. ​ Our ambition: To promote biodiversity by meeting the strategic challenges of our clients. CEHTRA is part of the H2B Group , specialized in testing, inspection and certification related to health and environment issues, on a human scale and with a strategic objective of digital transition. Our headquarters are located near Bordeaux and is present in Europe and worldwide with agencies in France (Bordeaux, Lyon, Paris), Germany, Belgium, Spain, United Kingdom, Canada and India. Key Business Sectors Biocides Chemicals (REACH) Cosmetics Global Chemicals Notification Industrial Hygiene Medical Devices Packaging Pharmaceuticals Plant Protection REACH Authorisation Key Services Dedicated Support (Régie) Endocrine Disruption Poison Centre Notifications Representative S ervices Trainings Digital Tools PRIMO CEHTRAcker COSMETICK ED Pedia Our project « Chèque transformation Numérique » has received a grant from the European Union under the FEDER-FSE Aquitaine 2014-2020 operational program. ​ CEHTRA has received a grant co-funded by Comunidad de Madrid and European Union to boost hiring young talents (Impulso a la contratación en Prácticas de Jóvenes para la Recuperación Económica) ​

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