Cosmetic Safety Assessment e-Training Module 5 Commences

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Cosmetic Safety Assessment e-Training
Module 5 – Packaging, Stability, Microbiology

4. October 2022 || 12 EST · 17 GMT · 18-19.30 CET

GLOBAL COSMETIC PRODUCT SAFETY ASSESSMENT TRAINING

The Course Concept at a Glance:  This coming February 2022, 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

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Experienced Safety Assessors (SAs) and beginners in the field

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Department Staff from: R&D, Regulatory Affairs, QA/QC, Testing, Formulation

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Responsible Persons (RPs) under the context of the Cosmetics Product Regulation

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Members of the Cosmetics, Chemicals/Raw Materials, Pharmaceutical, Packaging, Fragrance Industries

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Members of Regulatory Authorities

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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
ONLINE SEMINARS DATES – Next dates for Module 1 will be in January 2023
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
tba tba tba tba tba
Module 2: Toxicology 1
1 2 3 4 ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
22.02.22 01.03.22 08.03.22 15.03.22 25.03.22
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Toxicological
Endpoints
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
U. Rossow
A. Mehling
A. Mehling M. Kleber
U. Rossow
M. Kleber A. Mehling
M. Kleber
U. Rossow
Module 3: Toxicology 2
1 2 3 4 ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
29.03.22 05.04.22 12.04.22 26.04.22 06.05.22
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Acute Oral Toxicity 
Genotoxicity
Carcinogenicity
Repeated Dose Toxicity (Oral, Dermal) Data Use and Interpretation
 Acute Toxicity (Dermal, Inhalation) Reproduction Toxicity 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
Prof. C. Martin Prof. D. Yildiz Prof. D. Yildiz Prof. C. Martin Prof. C. Martin
Prof. D. Yildiz
Module 4: Exposure Criteria / Safety Margins

1 2 3 4 ATTENDANCE DAY
Tuesday Tuesday Tuesday Tuesday Friday
10.05.2022 17.05.2022 24.05.2022 31.05.2022 03.06.2022
18:00 – 19:30CET 18:00 – 19:30CET 18:00 – 19:30CET 18:00 – 19:30CET 11:00 – 17:30CET
Product Application Exposure 1 Exposure 2 Data Gaps Practical Application
Consumer Group Specifics / Skin Types Exposure Pathways – oral, dermal, inhalative Exposure to the Cosmetic Product

TTC Concept

NoG: Appendix 13 and TTC approach to botanical extracts

Data use and interpretation (practical exercises)
Normal and Reasonably Foreseeable Use Dose Descriptors (LD50, LC50, EC50, NOAEL, LOAEL, ADI, TDI, etc.) Exposure to the Substances Extrapolations & Approaches in Cases of Data Gaps

Discrepancies in SPF

Determination and Exposure

Presentation 

Specifics for various product groups:

– Fragrance Assessment

– Baby products

Weight of Evidence Approach Exposure to Impurities and Migrant Substances ReadAcross, QSAR Toolbox Calculation of Safety Margins (formulation examples)
LECTURER LECTURER LECTURER LECTURER LECTURER
Celia Campos Alex van der Burgh Uwe Rossow Marcus Kleber ALL Lecturers

 

Module 5: Packaging, Stability, Microbiology
1 2 3 4 ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
04.10.22 11.10.22 18.10.22 25.10.22 04.11.22
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Packaging Materials  Packaging –
Information Requirements
Product Stability
PhysChem Characteristics
Photostability
Microbiology
Types of Microorganisms
Stability Testing
in Various Product Categories
Impurities & Additives Applications 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
A. vd Burgh U. Rossow N. Georgiou U. Rossow A. vd Burgh
U. Rossow
N. Georgiou
Module 6: Animal Testing Ban / GMP / Claims / CPSR
1 2 3 4 ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
08.11.22 15.11.22 22.11.22 29.11.22 09.12.22
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Animal Testing / Quality / GMP Claims / Efficacy Borderline Products /
Cosmetovigilence / Statistics
CPSR – Key Contents  Practical Application
Animal Testing Ban & resulting
Requirements
Labelled Warnings and Instructions of Use Borderline between Efficacy and Safety CPSR – Format CPSR Format, Product Description, Product Traceability, Completion
Quality of
Testing Protocols
Safety Principles in Labelling Undesirable Effects / Serious Undesirable Effects Assessor Credentials,
Conclusion and Reasoning
CPSR
(practical exercise)
GMP: Principles & Contribution to Product Safety Functionality and Efficacy – Testing Statistics Greyzones between Safety Assessor and Responsible Person Proper GMP Documentation 
LECTURER(S) LECTURER(S) LECTURER(S) LECTURER(S) LECTURER(S)
M. Kleber
A. Struessmann
A. vd Burgh M. Iwobi
U. Rossow
U. Rossow M. Kleber
A. vd Burgh
M. Iwobi
U. Rossow

Why us?

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Independent safety assessors lecture based on experiences from daily work and projects

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Speed-up of the learning curve of future safety assessors, update of the skills of experienced safety assessors

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Continously updated state of the art knowledge of science and regulatory affairs

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Individual advice and feedback from the lecturers

Course Structure and Costs

Fee Structure: €1,400.00 per module
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Course Concept: The Modules are interlinked, but not strictly consecutive – any module provides a benefit on its own

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Tutorial: On-line self-learning phases are carried out before the full Attendance Day

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Flexible Learning: Due to the course structure participation is easily manageable while working on the job

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Attendance Days: All day is fully ONLINE; thus Covid-safe

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Exams: Each online-seminar is supervised by written tasks; any Attendance Day is ended with a written exam

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Predictability: All six modules will be offered within one calendar year

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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 2022

Please select Module(s) for Registering your participation in:

Terms & Conditions

Data Protection Declaration

FAQs

With Brexit a ‘done deal’, can I use the course for cosmetics assessment under UK law?
The course is teaching how to perform a science-based risk assessment on cosmetics and their ingredients. This approach is applicable independently from a regulatory scheme. The EU’s framework is chosen as base structure because in its legal text the assessment is laid down in detail in regard to necessary requirements and the assessment steps are supported by comprehensive guidance publications. Wherever decisions are based on specific legal requirements these are depicted during the course and can be translated from this description into other worldwide regulatory frameworks.
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?
The course can be attended and successfully completed without owning an academic degree, as it was observed in practice; yet, based on the existing strong engagement of the participant. However, under the EU’s cosmetic regulation it is required to possess a ‘diploma or other evidence of formal qualifications’ [Reg. (EC) 1223/2009, Art. 10 (2)], in order to legally sign on as Safety Assessor.
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

www.cpsr-education.com/