Training & Courses
At ToxHub, care is taken to understand our clients’ specific needs. Service delivery is customised accordingly to tackle the unique nature of their requirements.
Our experts will help you and your team by offering training courses on toxicological topics applicable to your interests. The courses will be carried out in your company and their content will be reviewed to meet your needs and requirements.
Toxicological Risk Assessment
Toxicological risk assessment is the process of estimating the qualitative and quantitative health risks posed to man and the environment by chemicals. The aim of this course is to familiarize participants with the general procedures followed during a toxicological risk assessment.
- General aspects of toxicological risk assessment
- Definition of the terms risk, hazard and exposure
- Introduction to risk assessment and management, with special attention to
- pharmaceutical and chemical risk assessment
- Role of ADME in risk assessment
- Identification and assessment of genotoxic and non-genotoxic carcinogens
- Identification and assessment of organ toxicity, including neurotoxicity, immunotoxicity, reprotoxicity, endocrine toxicity
- Exposure analysis in risk assessment
Introduction to toxicology for non-experts
The aim of the course is to offer participants, who seek vocational training but lack formal undergraduate training in toxicology, the opportunity to obtain basic knowledge and insight in toxicology.
- Define the term toxicology
- Describe the different ways in which chemicals can cause harm
- Explain the impact that chemo-physical properties can have on toxicity and exposure
- Define how to assess for toxicity
- Define the terms in vitro, ex vivo, in vivo
- Explain what is meant by the term “alternative methods” and how the 3R’s form part of these
- Explore the preclinical toxicity package to support the first-in-man
Advanced course on toxicology
The aim of the course is to introduce participants to the field of legal and regulatory toxicology. Regulatory toxicology is the process of producing, collecting and evaluating experimental toxicology data to facilitate toxicologically based decisions directed towards the protection of humans and the environment against harmful effects of chemical substances.
- Introduction to Regulatory Toxicology and Risk Assessment for Human Health
- ADME (Absorption, Distribution, Metabolism and Excretion): basics
- Acute systemic toxicity (oral, dermal, inhalation)
- Local tolerance: dermal, mucosal and ocular
- Skin sensitisation
- Repeated dose and chronic toxicity
- Reproductive toxicity and teratogenicity
- Mutagenesis and genotoxicity
- Introduction to non-experimental and alternative methods used in toxicology
- Introduction to the determination of toxicity reference values (Point of Departures)
Introduction to occupational toxicology
The field of occupational toxicology covers the use of chemicals in a workplace setting and includes the study of both raw materials and process emissions as possible hazards to human health. A general background on the methodology in the field of occupational toxicology will be provided.
- Hazard assessment of industrial chemicals by data-searching and SAR-modelling
- Characterization of inhalation and dermal exposures
- Characterization of internal exposure
- Inhalation toxicology
- Toxicology of industrial chemicals (irritants, sensitizers, corrosives, etc.)
- Carcinogens, mutagens and reproduction toxic substances (CMR-substances)
- Setting of occupational exposure limits (OEL)
- Occupational Exposure Banding assignment
Focus on National and International Guidelines
The world of pharmaceutical regulations is constantly evolving. ToxHub experts will provide training courses specific to the guidelines of your interest and shaped around your business and product needs.
- ICH M7(R1) – Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- ICH Q3D(R1) – Guideline on elemental impurities
- ICH S2(R1) – Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use
- EMA/CVMP/SWP/377245/2016 – Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products
- EMA/CHMP/ CVMP/ SWP/169430/2012 – Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
EU MDR: Biological evaluation of medical Devices
This training course will provide key guidance on successfully apply a risk management approach to the biological evaluation of medical devices. There will be plenty of time during the programme for interactive discussion with experts in this field. Participants can expect to learn how to use standards to establish a biological safety evaluation plan and to document and implement their plan. Use of material/chemical characterization and risk assessment will be highlighted, as will real-world exercises to practice evaluating biological risk.
- An introduction to medical devices
- An introduction to biocompatibility
- ISO 10993 history and development
- ISO 10993 structure and content
- Biocompatibility vs biological safety
- Endpoints to be addressed in a biological risk assessment
- Chemical characterisation
- Extractables and Leachables testing – when and why?
- Risk assessment using E&L data
- MDR safety requirements
Safety assessment of cosmetic products:
Cosmetics in the EU are regulated by Regulation (EC) N° 1223/2009, requiring that cosmetic products are proven to be safe before reaching the market. This must be done through safety assessment and for that purpose a unique dossier (Product Information File, PIF) needs to be composed by a qualified safety assessor. The aim of this course is to provide knowledge to participants on the EU regulation and its applicability in cosmetic safety evaluation.
- Regulation (EC) N° 1223/2009 overview
- Field of application
- Responsible Person, CPNP, Product Information File
- Borderline products
- Post-marketing survey (cosmetovigilance)
- Cosmetic Product Safety Report (CPSR) content and regulatory obligations
- Toxicological profile on ingredients
- Concept of safety assessment: calculation of MoS, local tolerance…
- Specific cases:
- Products for babies
- Evaluating non tested ingredients
- The interest of in silico methods
- Practical examples
- The impact of packaging on the safety of cosmetic products
- Intersections between regulations: REACH versus cosmetics