TRAINING COURSES

The aim of this course is to familiarize participants with the general concept of toxicology:
• What is toxicology
• Definition of the terms risk, hazard and exposure
• Definition of in vitro, in vivo, ex vivo
• ADME (Absorption, Distribution, Metabolism and Excretion): basics
• Acute systemic toxicity (oral, dermal, inhalation), LD50 and LC50
• Repeated dose systemic toxicity and organotoxicity, NOAEL, LOAEL, BMD
• Mutagenicity, toxicity to reproduction, genotoxic and non-genotoxic carcinogenicity

The aim of this course is to give an insight into the classification, labelling and packaging regulations (CLP):
• The basics of the CLP regulations
• High level explanation of the different toxicological and ecotoxicological endpoints, and the requested OECD guidelines for testing
• How to classify substances and mixtures
• Examples

The aim of this course to provide understanding of different guidelines in the pharma area, in order to ensure proper implementation of the guidelines:
• ICH Q3A – Impurities in New Drug Substances
• ICH Q3B – Impurities in New Drug Products
• ICH Q3E – Assessment and Control of Extractable and Leachables for Pharmaceuticals and Biologics
• ICH Q3D – Guideline on elemental impurities
• ICH Q3C – Guideline on residuals solvent
• ICH M7 – Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
• ICH S2 – 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
• PQRI – Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular)
• PQRI – Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Orally inhaled and Nasal Drug Product

The aim of this course is to describe the standards of interest, with focus on practical information to consider during a testing strategy.
Some examples of standards are:
• ISO 10993-1 – Evaluation and testing within a risk management process (refer to the specific course)
• ISO 10993-2 – Animal welfare requirements
• ISO 10993-3 – Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-4 – Selection of tests for interactions with blood
• ISO 10993-5 – Tests for in vitro cytotoxicity
• ISO 10993-6 – Tests for local effects after implantation
• ISO 10993 – Ethylene oxide sterilization residuals
• ISO 10993-9 – Framework for identification and quantification of potential degradation products
• ISO 10993-10 – Tests for skin sensitization
• ISO 10993-11 – Tests for systemic toxicity
• ISO 10993-12 – Sample preparation and reference materials
• ISO 10993-13 – Identification and quantification of degradation products from polymeric medical devices
• ISO 10993-16 – Toxicokinetic study design for degradation products and leachables
• ISO 10993-17 – Toxicological risk assessment of medical device constituents (refer to the specific course)
• ISO 10993-18 – Chemical characterization of materials
• ISO 10993-23 – Tests for irritation
• ASTM F2475 – Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Material
• FDA recognition
• Recommendation for testing
• Gap analysis

The aim of this course is to describe the safety evaluation of materials in contact with food, with special focus on plastic materials and articles:
• Introduction to the EU Regulation 1935/2004
• Introduction to different directive for different materials in contact with food
• Introduction to the EU Regulation 10/2011
• Definition of hazard and risk
• Definition of NIAS
• Identification of genotoxic and carcinogenic NIAS
• Derivation of the SML based on toxicological data, read across, in silico method (i.e. OECD QSAR and VEGA)
• TTC approach and cramer class
• Special consideration for specific substances (i.e. phthalates and bisphenol A)
• How to draw a testing plan
• Examples

The aim of this course is to support the definition of a testing strategy within REACH and to understand the fundamental concept about the most common OECD guidelines, as for instance (but not limited to):
• In Vitro Mammalian Cell Micronucleus Test, OECD TG 487
• In vitro mammalian cell gene mutation tests using the thymidine kinase Gene, OECD TG 490
• In vivo mammalian alkaline comet assay, EU, OECD TG 489
• Bacterial Reverse Mutation Test, OECD TG 471
• Defined Approaches (DA) method, OECD TG 497
• In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation, OECD TG 442E
• Repeated Dose 90-Day Oral Toxicity Study in Rodents, OECD TG 408
• Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, OECD 422
• Fish, Early-life Stage Toxicity Test, OECD TG 210
• Freshwater Alga and Cyanobacteria, Growth Inhibition Test, OECD TG 201
• Ready Biodegradability, OECD TG 301