{"id":629,"date":"2024-05-21T10:24:59","date_gmt":"2024-05-21T08:24:59","guid":{"rendered":"https:\/\/lenus.site\/scbest\/corsi-di-formazione\/"},"modified":"2025-01-08T10:56:51","modified_gmt":"2025-01-08T09:56:51","slug":"training-courses","status":"publish","type":"page","link":"https:\/\/sc-best.eu\/en\/training-courses\/","title":{"rendered":"Training courses"},"content":{"rendered":"

[vc_row][vc_column width=”1\/6″][\/vc_column][vc_column width=”2\/3″ css=”.vc_custom_1732705277943{margin-bottom: 40px !important;}”][vc_column_text]Our courses are tailor-made, designed to meet the needs of the applicant.<\/p>\n

They can be carried out in Italian<\/em> or ENG | <\/em>, in presence or via remote connection, to a single person or to groups of people. Courses may vary in length depending on the number of subjects covered and the level of depth.<\/p>\n

The list below should not be considered exhaustive, but merely lists a number of topics covered, among the most requested. These are grouped by subject; it is also possible to organize cross-curricular courses, with contents ranging between the various listed below.[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][\/vc_column][\/vc_row][vc_row content_placement=”top”][vc_column width=”1\/2″][vc_single_image image=”841″ img_size=”full” css=”.vc_custom_1728652232999{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_align=”left” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true”][vc_tta_section tab_id=”1716373813076-467b2e1a-21af” title=”TOXICOLOGICAL RISK ASSESSMENT FOR L&E IN PHARMA”][vc_column_text]The aim of this course is to familiarize participants with the general procedures followed during a toxicological risk assessment in the pharma area:<\/p>\n

\u2022 Introduction to the risk assesment
\n\u2022 Definition of the terms risk, hazard and exposure
\n\u2022 Definition of systemic toxicity, mutagenicity and cancerogenicity
\n\u2022 Definition of irritation and skin sensitization
\n\u2022 Definition of PDE and pharmaceutical risk assessment
\n\u2022 Introduction to ICH Q3C, ICH Q3D, ICH M7, PQRI guidelines
\n\u2022 Derivation of PDE from toxicological data, read across and silico methodologies
\n\u2022 Nitrosamines
\n\u2022 Examples[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”843″ img_size=”full” css=”.vc_custom_1728652279869{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true” css=”.vc_custom_1728641340390{margin-top: 0px !important;padding-top: 0px !important;}”][vc_tta_section tab_id=”1716375220975-db911f1d-326e” title=”INTRODUCTION TO TOXICOLOGY FOR NON-TOXICOLOGIST (PART 1 AND PART 2)”][vc_column_text]The aim of this course is to familiarize participants with the general concept of toxicology:
\n\u2022 What is toxicology
\n\u2022 Definition of the terms risk, hazard and exposure
\n\u2022 Definition of in vitro, in vivo, ex vivo
\n\u2022 ADME (Absorption, Distribution, Metabolism and Excretion): basics
\n\u2022 Acute systemic toxicity (oral, dermal, inhalation), LD50 and LC50
\n\u2022 Repeated dose systemic toxicity and organotoxicity, NOAEL, LOAEL, BMD
\n\u2022 Mutagenicity, toxicity to reproduction, genotoxic and non-genotoxic carcinogenicity[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row content_placement=”top”][vc_column width=”1\/2″][vc_single_image image=”845″ img_size=”full” css=”.vc_custom_1728652327723{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_align=”left” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true”][vc_tta_section tab_id=”1728642108035-5a9e3b90-eae8″ title=”TOXICOLOGICAL RISK ASSESSMENT ACCORDING TO ISO 10993-17:2023″][vc_column_text]The aim of this course is to familiarize participants with the general procedures followed during a toxicological risk assessment in in the medical devices area:
\n\u2022 Introduction to the risk assesment
\n\u2022 Definition of the terms risk, hazard and exposure
\n\u2022 Definition of systemic toxicity, mutagenicity and cancer
\n\u2022 Definition of TCI, TI, TTC
\n\u2022 Derivation of TI from toxicological data, read across and silico methodologies
\n\u2022 Definition of EEDmax, MOS
\n\u2022 Main differences with the previous version of ISO 10993-17: how to conduct a gap analysis
\n\u2022 Examples[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”847″ img_size=”full” css=”.vc_custom_1728652351220{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true” css=”.vc_custom_1728641340390{margin-top: 0px !important;padding-top: 0px !important;}”][vc_tta_section tab_id=”1728642108179-604b0553-a2a1″ title=”INTRODUCTION TO CLP REGULATION 1272\/2008″][vc_column_text]The aim of this course is to give an insight into the classification, labelling and packaging regulations (CLP):
\n\u2022 The basics of the CLP regulations
\n\u2022 High level explanation of the different toxicological and ecotoxicological endpoints, and the requested OECD guidelines for testing
\n\u2022 How to classify substances and mixtures
\n\u2022 Examples[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row content_placement=”top”][vc_column width=”1\/2″][vc_single_image image=”849″ img_size=”full” css=”.vc_custom_1728652395810{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_align=”left” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true”][vc_tta_section tab_id=”1728642996228-c2491982-27f6″ title=”INTRODUCTION TO REACH REGULATION 1907\/2006″][vc_column_text]The aim of this course is to give an insight into the classification, labelling and packaging regulations (CLP) and on the role of Regulatory Affairs Experts:
\n\u2022 The basics of the REACH regulations
\n\u2022 The content of the different Annexes
\n\u2022 The testing requirements
\n\u2022 Substances of Very High Concern (SVHC)
\n\u2022 Registrant and Consortia[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”851″ img_size=”full” css=”.vc_custom_1728652427198{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true” css=”.vc_custom_1728641340390{margin-top: 0px !important;padding-top: 0px !important;}”][vc_tta_section tab_id=”1728642996318-d37766b2-1f1c” title=”ICH GUIDELINES AND MORE”][vc_column_text]The aim of this course to provide understanding of different guidelines in the pharma area, in order to ensure proper implementation of the guidelines:
\n\u2022 ICH Q3A \u2013 Impurities in New Drug Substances
\n\u2022 ICH Q3B \u2013 Impurities in New Drug Products
\n\u2022 ICH Q3E \u2013 Assessment and Control of Extractable and Leachables for Pharmaceuticals and Biologics
\n\u2022 ICH Q3D \u2013 Guideline on elemental impurities
\n\u2022 ICH Q3C – Guideline on residuals solvent
\n\u2022 ICH M7 – Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
\n\u2022 ICH S2 \u2013 Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use
\n\u2022 EMA\/CVMP\/SWP\/377245\/2016 \u2013 Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products
\n\u2022 EMA\/CHMP\/ CVMP\/ SWP\/169430\/2012 \u2013 Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
\n\u2022 PQRI – Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Parenteral Drug Products (Intravenous, Subcutaneous, and Intramuscular)
\n\u2022 PQRI – Safety Thresholds and Best Demonstrated Practices for Extractables and Leachables in Orally inhaled and Nasal Drug Product[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row content_placement=”top”][vc_column width=”1\/2″][vc_single_image image=”853″ img_size=”full” css=”.vc_custom_1728652462524{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_align=”left” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true”][vc_tta_section tab_id=”1728643456118-b283b425-c5df” title=”INSIDE THE ISO 10993-1″][vc_column_text]The aim of this course is to familiarize participants with the standard:
\n\u2022 ISO 10993-1 in the context of the risk assessment
\n\u2022 Definitions
\n\u2022 General principles applicable to the evaluation of the medical devices
\n\u2022 Categorization of the medical device by nature of body contact
\n\u2022 Categorization of the medical device by duration of contact
\n\u2022 Biological evaluation process
\n\u2022 FDA guidelines: differences with the ISO 10993-1
\n\u2022 Recommendation for testing[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”853″ img_size=”full” css=”.vc_custom_1728652496602{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true” css=”.vc_custom_1728641340390{margin-top: 0px !important;padding-top: 0px !important;}”][vc_tta_section tab_id=”1728643456259-f83a2166-4d66″ title=”INSIDE THE ISO STANDARDS”][vc_column_text]The aim of this course is to describe the standards of interest, with focus on practical information to consider during a testing strategy.
\nSome examples of standards are:
\n\u2022 ISO 10993-1 – Evaluation and testing within a risk management process (refer to the specific course)
\n\u2022 ISO 10993-2 – Animal welfare requirements
\n\u2022 ISO 10993-3 – Tests for genotoxicity, carcinogenicity and reproductive toxicity
\n\u2022 ISO 10993-4 – Selection of tests for interactions with blood
\n\u2022 ISO 10993-5 – Tests for in vitro cytotoxicity
\n\u2022 ISO 10993-6 – Tests for local effects after implantation
\n\u2022 ISO 10993 – Ethylene oxide sterilization residuals
\n\u2022 ISO 10993-9 – Framework for identification and quantification of potential degradation products
\n\u2022 ISO 10993-10 – Tests for skin sensitization
\n\u2022 ISO 10993-11 – Tests for systemic toxicity
\n\u2022 ISO 10993-12 – Sample preparation and reference materials
\n\u2022 ISO 10993-13 – Identification and quantification of degradation products from polymeric medical devices
\n\u2022 ISO 10993-16 – Toxicokinetic study design for degradation products and leachables
\n\u2022 ISO 10993-17 – Toxicological risk assessment of medical device constituents (refer to the specific course)
\n\u2022 ISO 10993-18 – Chemical characterization of materials
\n\u2022 ISO 10993-23 \u2013 Tests for irritation
\n\u2022 ASTM F2475 – Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Material
\n\u2022 FDA recognition
\n\u2022 Recommendation for testing
\n\u2022 Gap analysis[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row content_placement=”top”][vc_column width=”1\/2″][vc_single_image image=”855″ img_size=”full” css=”.vc_custom_1728652527244{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_align=”left” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true”][vc_tta_section tab_id=”1728643778040-031485cb-ddad” title=”BIOLOGICAL EVALUATION PLAN AND A BIOLOGICAL EVALUATION REPORT FOR EU AND FDA SUBMISSIONS”][vc_column_text]The aim of this course is to familiarize participants with the preparation and impact of the documents related to Biological Evaluation:
\n\u2022 Structure of a Biological Evaluation Plan
\n\u2022 Definition of a medical device
\n\u2022 Categorization of the medical device according to ISO 10993-1
\n\u2022 Relevant elements in the description of the medical device, including packaging and manufacturing
\n\u2022 Risk assessment of the packaging
\n\u2022 Risk assessment of the manufacturing
\n\u2022 Testing strategies
\n\u2022 Does\/don\u2019t
\n\u2022 Main differences between a Biological Evaluation Plan and Report for EU and FDA submission[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”857″ img_size=”full” css=”.vc_custom_1728652552383{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_align=”left” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true”][vc_tta_section tab_id=”1728644103181-b9ffd0c1-6635″ title=”SAFETY ASSESSMENT OF COSMETIC PRODUCTS”][vc_column_text]The aim of this course is to familiarize participants with the safety evaluation of cosmetic ingredients and products:
\n\u2022 Introduction to the EU Regulation on cosmetics product 1223\/2009
\n\u2022 SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation
\n\u2022 SCCS opinions
\n\u2022 European Ban
\n\u2022 Toxicological profile of the ingredients by means of toxicological data, read across or in silico methods.<\/p>\n

Introduction to NAMS:
\n\u2022 NOAEL, TTC, MOS
\n\u2022 Description of the conditions of use
\n\u2022 Exposure review of the finished product and its ingredients, retention factors
\n\u2022 3Rs principles, New Approach Methodologies (NAMs), Next-Generation Risk Assessment (NGRA), weight of evidence
\n\u2022 Conclusions
\n\u2022 Examples[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row content_placement=”top”][vc_column width=”1\/2″][vc_single_image image=”859″ img_size=”full” css=”.vc_custom_1728652586694{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true” css=”.vc_custom_1728641340390{margin-top: 0px !important;padding-top: 0px !important;}”][vc_tta_section tab_id=”1728643778136-59c04525-8628″ title=”FOOD CONTACT MATERIAL COMPLIANCE AND NIAS EVALUATION”][vc_column_text]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:
\n\u2022 Introduction to the EU Regulation 1935\/2004
\n\u2022 Introduction to different directive for different materials in contact with food
\n\u2022 Introduction to the EU Regulation 10\/2011
\n\u2022 Definition of hazard and risk
\n\u2022 Definition of NIAS
\n\u2022 Identification of genotoxic and carcinogenic NIAS
\n\u2022 Derivation of the SML based on toxicological data, read across, in silico method (i.e. OECD QSAR and VEGA)
\n\u2022 TTC approach and cramer class
\n\u2022 Special consideration for specific substances (i.e. phthalates and bisphenol A)
\n\u2022 How to draw a testing plan
\n\u2022 Examples[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column width=”1\/2″][vc_single_image image=”861″ img_size=”full” css=”.vc_custom_1728652609213{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true” css=”.vc_custom_1728641340390{margin-top: 0px !important;padding-top: 0px !important;}”][vc_tta_section tab_id=”1728644103345-b60fdd1b-1c9b” title=”TOXICOLOGY AND TOXICOLOGICAL TESTING”][vc_column_text]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):
\n\u2022 In Vitro Mammalian Cell Micronucleus Test, OECD TG 487
\n\u2022 In vitro mammalian cell gene mutation tests using the thymidine kinase Gene, OECD TG 490
\n\u2022 In vivo mammalian alkaline comet assay, EU, OECD TG 489
\n\u2022 Bacterial Reverse Mutation Test, OECD TG 471
\n\u2022 Defined Approaches (DA) method, OECD TG 497
\n\u2022 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
\n\u2022 Repeated Dose 90-Day Oral Toxicity Study in Rodents, OECD TG 408
\n\u2022 Combined Repeated Dose Toxicity Study with the Reproduction\/Developmental Toxicity Screening Test, OECD 422
\n\u2022 Fish, Early-life Stage Toxicity Test, OECD TG 210
\n\u2022 Freshwater Alga and Cyanobacteria, Growth Inhibition Test, OECD TG 201
\n\u2022 Ready Biodegradability, OECD TG 301[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][\/vc_row][vc_row content_placement=”top”][vc_column width=”1\/2″][vc_single_image image=”851″ img_size=”full” css=”.vc_custom_1728652813342{margin-bottom: 0px !important;padding-bottom: 0px !important;}”][vc_tta_accordion title_tag=”h4″ color=”white” c_align=”left” c_position=”right” active_section=”” css_animation=”top-to-bottom” collapsible_all=”true”][vc_tta_section tab_id=”1728644327625-230c6184-c31c” title=”CALIFORNIA P65″][vc_column_text]The aim of this course is to familiarize participants with the requirements of the California P65, in order to define the approach in case of samples containing listed substances:
\n\u2022 Introduction to the California P65
\n\u2022 California \u201cwarning\u201d
\n\u2022 Definition of the terms risk, hazard and exposure
\n\u2022 Definition of systemic toxicity, mutagenicity, cancerogenicity, toxicity to reproduction
\n\u2022 Definition and calculation of MADL and NSRL
\n\u2022 Exposure Assessment
\n\u2022 Risk assessment and MOS calculation
\n\u2022 Examples[\/vc_column_text][\/vc_tta_section][\/vc_tta_accordion][\/vc_column][vc_column width=”1\/2″][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” equal_height=”yes” content_placement=”middle” css=”.vc_custom_1728651782775{background-color: #efefef !important;}”][vc_column width=”1\/3″][vc_single_image image=”838″ img_size=”full” alignment=”center”][\/vc_column][vc_column width=”2\/4″][vc_column_text]<\/p>\n

ON-DEMAND <\/strong>COURSES<\/h3>\n

Users can request customized toxicology training courses, designed to meet their specific needs and professional goals. This flexibility allows for in-depth study of relevant topics and targeted skill development, ensuring more effective learning.[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1732879135830{background-image: url(https:\/\/sc-best.eu\/wp-content\/uploads\/2024\/05\/SC-BEST_CORSI-FORMAZIONE-1.png?id=254) !important;background-position: center !important;background-repeat: no-repeat !important;background-size: cover !important;}”][vc_column width=”1\/3″][vc_column_text]<\/p>\n

Are you interested<\/span>
\nour courses?<\/span><\/h2>\n

Fill out the form to get more information or request a specific course tailored to your needs<\/span>[\/vc_column_text][\/vc_column][vc_column width=”2\/3″]\n

\n

<\/p>

    <\/ul><\/div>\n
    \n
    \n\n\n\n\n\n\n\n<\/div>\n
    \n\t
    \n\t\t

    \n\t\t

    \n\t
    \n\t\t

    \n\t\t

    \n\t
    \n\t\t

    \n\t
    \n\t\t