++++ ATTENDANCE-DAYS 2021 ONLINE ++++

Fees for course participation occur. Please check the ‚Quick-Facts‘ section below!

In Today’s Global Economy, why are these Safety Assessment Training Courses important?

Product and material safety is mandatory for the protection of consumer health; therefore, a science-based risk assessment is requested and laid down for the different consumer product groups in many European and worldwide regulatory frameworks. Modern cosmetic products and their ingredients are often based on new technologies, while at the same time the knowledge on substances and products is continuously increasing due to new legal approaches and scientific methods.

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.

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Quick-Facts

  • Fee structure: €1,400.00 per module

  • Attendance days: All fully Corona-safe: ONLINE

  • Flexible Course Concpet: Due to modular structure easily managable beside the job
  • Booking Options: Complete course starting May 2021 or module 4, 5 or 6 on its own
  • Course Concept: The Modules are planned in a thoughtful way, they are interlinked but not strictly consecutive. So any module provides a benefit on its own.

  • Achievements: RWTH-Certificate of attendance (upon successful termination). Based on the pre-condition of an available ‘diploma or other evidence of formal qualifications’, acc. to Reg. (EC) 1223/2009, Art. 10 (2), a cosmetics safety assessment can be performed and signed as Safety Assessor. For more information, please visit:

What is the CCE/RWTH International Academy’s Training Course Concept?

The course is split into six modules. Each module consists of four online seminars and one face-to-face event. This event tis held ONLINE and allows a full day of repitition and discussion of the online seminars.

The content of a module will be presented in detail during the first online seminar. Online self-learning phases are carried out prior the attendance modules, and participants complete a written exam at the end of each attendance day. Each module can be booked individually. The participant will receive a certificate of attendance for each module. After completing and passing the examination of all 6 modules, the participants will receive the official certificate of participation „Safety Assessment for Cosmetic Products“.

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY
Tuesday Tuesday Tuesday Tuesday Friday
09.02.2021 16.02.2021 23.02.2021 02.03.2021 12.03.2021
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Packaging Materials 1 Packaging Materials 2 Product Stability Microbiology Practical application
Packaging Materials – Types of Packagings and Implications on Safety Packaging Materials in Cosmetics -Information Requirements Physical/chemical Characteristics, Stability, Photostability: Safety Relevance and Testing Microbiological Testing – Types of Microorganisms concerned, Testing Methods, Challenge Test How to read/interpret a microbiological challenge test / microbiological stability test – validity and suitability
Plastics’ Packaging Production – Impurities and Additives Packaging Assessment – Food Law applicable to Cosmetics Product Stability Testing and Packaging Compatibility Testing Microbiological Purity: Aspects for Raw Materials, Products and Manufacturing Packaging material assessment
– Different kinds of certificates of food contact material compliance
– Traps and solutions – what if mandatory info is missing
– Individual approaches (e.g. read across or performance of e.g. migration tests)
Recycled Packaging Materials Packaging Assessment – Criteria and Points to be considered in SA Shelf Life, PAO laboratory – visit
LECTURER LECTURER LECTURER LECTURER LECTURER
Alex vd Burgh Uwe Rossow Natalia Georgiou Uwe Rossow Alex vd Burgh

Uwe Rossow

Natalia Georgiou

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY
Tuesday Tuesday Tuesday Tuesday Friday
13.04.2021 20.04.2021 27.04.2021 04.05.2021 14.05.2021
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 / Assessor Credentials Practical Application
Animal Testing Ban, Requirements resulting from the Animal Testing Ban Claims, Labelled Warnings and Instructions of Use Borderline between Efficacy and Safety The Cosmetic Product Safety Report – A practical Approach towards Format, Product Identification, Product Traceability, Completion How to do a Safety Assessment (practical exercise with a example formula)
Quality of Testing Protocols Results from Safety Assessment to be recognized in Labelling Undesirable Effects and Serious Undesirable Effects Assessor Credentials,
Key Contents of Assessment, Conclusion and Reasoning		 How to prepare a CPSR (practical exercise with a example formula)
GMP: Principles and Contribution to Product Safety Functionality and Efficacy – Testing Statistics Responsibility Greyzones between Safety Assessor and Responsible Person Proper documentation – how to prepare internal documents in order to be prepared for audits / challenges / inspections
LECTURER(S) LECTURER(S) LECTURER(S) LECTURER(S) LECTURER(S)
Markus Kleber
Annemie Lambert		 Alex van der Burgh Mabel Iwobi
Uwe Rossow		 Uwe Rossow Markus Kleber
Annemie Lambert
Alex van der Burgh
Mabel Iwobi
Uwe Rossow

ONLINE SEMINARS DATES
1 2 3 4

ATTENDANCE DAY
Tuesday Tuesday Tuesday Tuesday Friday
25.05.21 01.06.21 08.06.21 15.06.21 25.06.21
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
The European Union and its industry regulation Regulation (EC) 1223/2009 on Safety Assessment Cosmetics‘ and horizontal legislation Raw Material Criteria Practical Approach to Safety Assessment
Introduction-Training Goals & Principles Principles of Safety Assessment Annex I – CPSR                                                   Information Requirements Raw Material Sources – Manufacturing Processes How to do a raw material safety assessment – data collection, data research, impurity status, documentation
The EU’s Common Market The Scientific Committee for Consumer Safety – Notes of Guidance Specifics for Fragrances Intrinsic Properties of Substances Evaluation what is good, necessary, supporting information –  (practical exercises)
The Cosmetics Product Regulation The dual Approach towards Ingredients’ Safety Raw Materials, Ingredients                           Ingredient Descriptors (INCI, EC, etc.) Substances from different Origin Cosmetic manufacturing: Where hazards may appear –  Location visit (TBD)
The PIF Substances regulated in the Annexes Impurities’ Sources and their Relevance for Product Safety Impurities from Manufacturing and their Relevance for Product Safety
LECTURER LECTURER LECTURER LECTURER LECTURER
tba tba tba tba tba

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY

ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
tba tba tba tba tba
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Skin Physiology Skin Sensitization
 Skin  Irritation / Dermatological Tests of Cosmetic products
 Skin Cancer / Clinical Signs / Phototoxicity
 Practical application
Toxicological endpoints to be considered in Safety Assessments of skin care products and Cosmetics Skin Sensitization – Toxicological considerations Skin Irritation – Toxicological considerations Skin cancer Research strategies for toxicological information on raw materials
Skin physiology with special emphasis on skin absorption and metabolism, sensitization and interactions with UV light Skin sensitization – Testing methods Mucous Membrane Irritation – Toxicological considerations Phototoxicity, Photosensitization Filling data gaps: Read across, conclusions by analogy and other approaches – practical examples
Test methods for Skin Irritation and Mucous Membrane/Eye Irritation Clinical signs and symptoms of allergic contact dermatitis, hand eczema and other skin diseases Start to prepare a CPSR – implement toxicological data – practical advise
LECTURER LECTURER LECTURER LECTURER LECTURER
Dr. U. Rossow

Prof. Dr. Merk

 Prof. Dr. Blömeke Prof. Dr. Blömeke

Dr. U. Rossow

 Prof. Dr. Merk Prof. Dr. Merk

Prof. Dr. Blömeke

Dr. U. Rossow

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY

ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
tba tba tba tba tba
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Acute Toxicity Systemic Toxicity 1+2 Systemic Toxicity 3
 Systemic Toxicity 4+5 Practical application
Acute Toxicity (Oral, Dermal, Inhalation, including Skin/Eye Irritation and Corrosion):
a) Existing test methods,
b) Outlook to alternative methods
c) Endpoint (LD50, EC50, etc.)		 Systemic Toxicity 1 – Genotoxicity:
a) Existing Test Methods,
b) Outlook to Alternative Methods		 Systemic Toxicity 3 – Carcinogenicity
a) Existing Test Methods,
b) Outlook to Alternative Methods		 Systemic Toxicity 4 – Repeated Dose Toxicity (Oral, Dermal):
a) Existing Test Methods,
b) Outlook to Alternative Methods
c) Endpoint NOAEL		 Developing assessment strategies (practical exercises)
Dermal Systemic Toxicity 2 – Toxicity for Reproduction:
c) Existing Test Methods,
d) Outlook to Alternative Methods
e) Endpoint NOAEL		 Uncertainty factors
a) Route-to-route Extrapolation
b) Study Design
c) Study Duration		 Absorption Systemic Toxicity 5 – Repeated Dose Toxicity (Inhalation):
a) Existing Test Methods,
b) Outlook to alternative methods
c) Endpoint NOAEC		 Data use and interpretation (practical exercises)
ADME Relevance of Toxicological Endpoints for Safety Assessment Calculation of Safety Margins (formulation examples)
LECTURER LECTURER LECTURER LECTURER LECTURER
Prof. Dr. C. Martin Prof. Dr. D. Yildiz Prof. Dr. D. Yildiz Prof. Dr. C. Martin Prof. Dr. C. Martin

Prof. Dr. D. Yildiz

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY
Tuesday Tuesday Tuesday Tuesday Friday
tba tba tba tba tba
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 09:00 – 17:00
Product Use Exposure 1 Exposure 2 Data Gaps Practical application
Consumer Group Specifics / Skin Types Exposure to the Cosmetic Product Exposure Pathways – oral, dermal, inhalative TTC Concept Developing assessment strategies (practical exercises)
Normal and Reasonably Foreseeable Use Exposure to the Substances Dose Descriptors (LD50, LC50, EC50, NOAEL, LOAEL, ADI, TDI, etc.) Extrapolations & Approaches in Cases of Data Gaps Data use and interpretation (practical exercises)
Significance of the various Testing Results in Safety Assessment (SA) Exposure to Impurities and Migrant Substances Weight of Evidence Approach ReadAcross, QSAR Toolbox Calculation of Safety Margins (formulation examples)
LECTURER LECTURER LECTURER LECTURER LECTURER
Celia Campos Uwe Rossow Alex van der Burgh Marcus Kleber Celia Campos

Uwe Rossow

Alex van der Burgh

Marcus Kleber

What are the Target Groups?

The Cosmetics Product Regulation (EC) 1223/2009 and many other world-wide regulatory frameworks put the responsibility for product safety on the manufacturers or importers of products. Amongst other requirements, they have to ensure that a safety assessment for the products is performed before being placed on the market. Theoretical knowledge and practical methods how to obtain and to manage all necessary scientific and analytical data is essential to complete this scientifically sound and legally compliant. Based on these pre-conditions the addressed target groups for the training include the following:

  • Safety Assessors (SAs) and beginners in the field
  • Department Staff: R&D, Regulatory Affairs, QA/QC, Testing, Formulation
  • Members of the Cosmetics, Chemicals/Raw Materials, Pharmaceutical, Packaging, Fragrance Industries
  • Responsible Persons (RPs) under the context of the Cosmetics Product Regulation
  • All graduates in Toxicology, Chemistry, Biology, Pharmacology, Life Sciences, Product Technology with interest in continuing education and specialization

The Safety Report is the core of the Product Information File (PIF). It must be prepared by the SA in cooperation with the RP. The actors are based globally and responsible for the assessment of products that are either placed on the EU’s internal market or in nations with similar safety requirements.

What ‘added-value’ do these courses offer Participants?

  • Access to lecturers with targeted expertise in the field, who are offering their scientific and professional experiences coming from their own daily work and projects
  • Building skills and abilities to carry out safety assessments correctly and independently (dependant on legal and personal pre-requisites)
  • Individual advice and feedback from the lecturers
  • Further modules or courses can be provided on demand and/or on needs
  • The training platform allows and encourages participant ‘networking’
  • A training program at the RWTH University-Aachen, Germany, a university with ‘excellence’ status
  • A master course is in preparation and from the SA course credits thereto can be earned (based on available graduate status of the participant)

Please check out the latest Press Release by Cosmetics design-europe.com

Read More

For further Information please contact: 

Mr. Marko Gerstenkorn
Business Unit Manager

cpsr@academy.rwth-aachen.de
+49 241 80-27696

Campus-Boulevard 30
52074 Aachen

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