MODULE 2: TOXICOLOGY 1 COMMENCES
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MODULE 2: TOXICOLOGY 1
14. March 2023 || 12 EST · 17 GMT · 18-19:30 CET incl. Q&A
SCIENTIFIC AND TEACHING CONCEPT
EDUCATIONAL REQUIREMENTS
WORLDWIDE SCOPE DISCUSSION
GLOBAL COSMETIC PRODUCT SAFETY ASSESSMENT TRAINING
The Course Concept at a Glance: This coming February 2023, Cosmetics Consultants Europe (CCE) will commence its ‘online’ Cosmetic Safety Assessment ‘e-Training courses. All modules will be taught by industry experts as such assuring contents close to the cosmetics safety assessment practice
The training program will enable participants to perform Safety Assessments (SAs) for cosmetic products in both the EU & UK, which are formulated, manufactured and marketed on a worldwide scale.
The scientific and regulatory concept is based on the European Regulation N° 1223/2009 on Cosmetic Products and the related guidance publications, while also support for application under other regulatory frameworks is part of the curriculum.
Target Groups
Experienced Safety Assessors (SAs) and beginners in the field
Department Staff from: R&D, Regulatory Affairs, QA/QC, Testing, Formulation
Responsible Persons (RPs) under the context of the Cosmetics Product Regulation
Members of the Cosmetics, Chemicals/Raw Materials, Pharmaceutical, Packaging, Fragrance Industries
Members of Regulatory Authorities
All graduates in Toxicology, Chemistry, Biology, Pharmacology, Life Sciences, Product Technology with interest in continuing education and specialization
Our Methodology
6 Training Modules: Each module consists of 4 online-seminars of 90 minutes and a full Attendance Day
Module 1: Regulation on cosmetic products and their safety
1 |
2 |
3 |
4 |
ATTENDANCE DAY ONLINE |
Tuesday | Tuesday | Tuesday | Tuesday | Friday |
07.02.23 | 14.02.23 | 21.02.23 | 28.02.23 | 10.03.23 |
18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 11:00 – 17:30 |
Training Goals & Principles | Principles of Safety Assessment | Annex I / CPR | Raw Material Criteria | Practical Approach to Safety Assessment |
The EU’s Common Market & Industry Regulation | The SCCS – Notes of Guidance | Information Requirements | Intrinsic Properties Ingredient Origin | Data Collection, Impurity Research |
Cosmetics Product Regulation / PIF | Regulated Substances | Ingredient Descriptors (INCI, EC, etc.) | Impurities | Documentation |
LECTURER | LECTURER | LECTURER | LECTURER | LECTURER |
Raphael Sauerwein |
Alex vd Burgh | Alex vd Burgh | Uwe Rossow | All |
Module 2: Toxicology 1
1 |
2 |
3 |
4 |
ATTENDANCE DAY ONLINE |
Tuesday | Tuesday | Tuesday | Tuesday | Friday |
14.03.23 | 21.03.23 | 28.03.23 | 18.04.23 | 21.04.23 |
18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 11:00 – 17:30 |
Toxicological Endpoints in Cosmetics Safety Assessment | Skin Sensitization | Skin Irritation | Phototoxicity | Research Strategies for Toxicological Information |
Skin Physiology | Test Methods | Mucous Membrane Irritation | Photosensitization | Filling Data Gaps Starting a CPSR |
LECTURER | LECTURER | LECTURER | LECTURER | LECTURER |
Uwe Rossow |
Annette Mehling | Marcus Kleber | Uwe Rossow | All |
Module 3: Toxicology 2
1 |
2 |
3 |
4 |
ATTENDANCE DAY ONLINE |
Tuesday | Tuesday | Tuesday | Tuesday |
Friday |
25.04.23 | 02.05.23 | 09.05.23 | 16.05.23 | 26.05.23 |
18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 11:00 – 17:30 |
Acute Oral Toxicity |
Genotoxicity |
Carcinogenicity |
Repeated Dose Toxicity (Oral, Dermal) |
Data Use and Interpretation |
Acute Toxicity (Dermal, Inhalation) | Toxicity for Reproduction | Uncertainty Factors | Repeated Dose Toxicity (Inhalation) | Developing Assessment Strategies |
ADME | Test Methods, Endpoint NOAEL |
Relevance of Toxicogical Endpoints | Endpoint NOAEC | Data Sources |
LECTURER | LECTURER | LECTURER | LECTURER | LECTURER |
tba | tba | tba | tba | tba |
Module 4: Exposure Criteria / Safety Margins
1 |
2 |
3 |
4 |
ATTENDANCE DAY ONLINE |
Tuesday | Tuesday | Tuesday | Tuesday | Friday |
06.06.23 | 13.06.23 | 20.06.23 | 27.06.23 | 30.06.23 |
18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 |
18:00 – 19:30 |
11:00 – 17:30 |
Consumer Group Specifics / Skin Types | Exposure to the Cosmetic Product | Exposure Pathways (Oral, Dermal, Inhalation) |
TTC Concept |
Developing Assessment Strategies |
Normal and Reasonably Foreseeable Use | Exposure to Substances | Dose Descriptors |
Extrapolations |
Exposure Considerations |
Significance of Testing Results | Exposure to Impurities | Weight of Evidence Approach |
Read-across, QSAR Toolbox |
Calculation of Safety Margins |
LECTURER | LECTURER | LECTURER |
LECTURER |
LECTURER |
tba | tba | tba |
tba |
tba |
Module 5: Packaging, Stability, Microbiology
1 |
2 |
3 |
4 |
ATTENDANCE DAY ONLINE |
Tuesday | Tuesday | Tuesday | Tuesday | Friday |
03.10.23 | 10.10.23 | 17.10.23 | 24.10.23 | 03.11.23 |
18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 11:00 – 17:30 |
Packaging Materials | Packaging -Information Requirements | Product Stability, PhysChem Characteristics, Photostability | Microbiology, Types of Microorganisms | Stability Testing in Various Product Categories |
Impurities and Additives | Applicability of Food Law | Packaging Compatibility | Challenge Testing | Practical Approach to Packaging Assessment |
Recycled Packaging | Packaging Assessment | Shelf Life, PAO | Microbiological Purity | How to read Microbiological Tests |
LECTURER | LECTURER | LECTURER | LECTURER | LECTURER |
tba | tba | tba | tba | tba |
Module 6: Animal Testing Ban / GMP / Claims / CPSR
1 |
2 |
3 |
4 |
ATTENDANCE DAY ONLINE |
Tuesday | Tuesday | Tuesday | Tuesday | Friday |
07.11.23 | 14.11.23 | 21.11.23 | 28.11.23 | 08.12.23 |
18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 18:00 – 19:30 | 11:00 – 17:30 |
Animal Testing / Quality / GMP | Claims, Efficacy | CPSR | Borderline / Cosmetovigilence | Practical Applications |
Animal Testing Ban & resulting Requirements | Claims, Labelled Warnings and Instructions of Use | The CPSR – Format, Product Identification, & Traceability, Approach | Borderline Product / Interface between Efficacy and Safety | How to prepare a CPSR – practical exercise with an example formulation |
Quality of Testing Protocols | Results from SA to be recognized in Labelling | Assessor Credentials, Key SA Contents, Conclusion & Reasoning | Cosmetovigilance > UEs and SUEs | Proper Documentation |
GMP: Principles & Contribution to Product Safety | Functionality and Efficacy – Testing | Grey zones between Safety Assessor and Responsible Person | Statistics | Challenges / Inspections |
LECTURER | LECTURER | LECTURER | LECTURER | LECTURER |
Marcus Kleber Fabienne Hins |
Alex vd Burgh | Uwe Rossow | Mabel Iwobi Uwe Rossow |
All |
Why us?
Independent safety assessors lecture based on experiences from daily work and projects
Speed-up of the learning curve of future safety assessors, update of the skills of experienced safety assessors
Continously updated state of the art knowledge of science and regulatory affairs
.
Individual advice and feedback from the lecturers
Course Structure and Costs
Fee Structure: €1,400.00 per module
Course Concept: The Modules are interlinked, but not strictly consecutive – any module provides a benefit on its own
Tutorial: On-line self-learning phases are carried out before the full Attendance Day
Flexible Learning: Due to the course structure participation is easily manageable while working on the job
Attendance Days: All day is fully ONLINE; thus Covid-safe
Exams: Each online-seminar is supervised by written tasks; any Attendance Day is ended with a written exam
Predictability: All six modules will be offered within one calendar year
Achievements: CCE’s Safety Assessment Modules will enable participants to perform SAs for cosmetics according to the Cosmetics Product Regulation N° 1223/2009. Our industry experts will contribute their hands-on experiences from doing SAs.
Our e-Training will support those striving to do safety assessments for both the EU & UK markets with further advances one’s cosmetic sciences.
Upon successful course completion, CCE will issue its own certificate for performing Safety Assessments. To perform SAs for clients, companies, etc., it’s really more about what one gleans from the training and fully applies it to their professional regulatory work!
Registration for CCE Safety Assessment e-Training Modules
Starting February 2023
FAQs
With Brexit a ‘done deal’, can I use the course for cosmetics assessment under UK law?
What qualification do I need to have to take the module(s)?
Cosmetics safety assessment is a complex exercise involving interdisciplinary scientific approaches in the fields of toxicology, chemistry, pharmacology, biology/life sciences, as well as product and packaging technology and regulatory affairs. All areas will be addressed during the training program, and it will also stimulate and demand to be complemented by the active engagement of the participants. The experience shows that the participants come with various backgrounds; therefore, everybody has strength and weaknesses and these need to be balanced in the self learning phases.
Do I need an academic degree for attending the course?
How much time is required to complete the course successfully?
Solid data on intrinsic properties of product ingredients are required, as well as on the potential occurrence of harmful contaminants and microbiological burden. This data and further information on the properties and effects of substances and formulations serve as the basis for exposure and risk assessments. The demand on knowledge and skills of product safety assessors is enormous and is constantly growing based on new scientific and regulatory results. Therefore, the learning is ongoing and the course is giving the start to the continuous learning approach.
Cosmetics Consultants Europe (CCE) is a pan-European industry association uniting consultant working in the cosmetics, cosmetic ingredients and borderline industries –
For more information email to Steven L. Hanft: sg@ccecosmetic.org