2) 解析EpiSkinTM 体外皮肤刺激性测试方法(OECD TG 439)
3) 应用EpiSkinTM 模型的体外皮肤刺激性测试方法演示和数据分析演示
EPISKIN Academy at Nelson Labs seminar
Dr. Christian Pellevoisin, Scientific Director at Episkin Academy, will present 'Assessing Alternatives to In-Vivo testing: Changing the Paradigm from In-Vivo to In-Vitro Toxicology' during the Nelson Labs seminar in Brabanthal, Leuven, Belgium, March 4 & 5, 2020.
Leuven Open House 2020: The Year Of Change for the Medical Device Industry
Wednesday, March 04, 2020
12:00 Registration & welcome
13:10 Introduction – Eric Meyers (Senior VP EMEAA Nelson Labs) & Jos Bollen (Managing Director Nelson Labs Europe)
13:30 The EU Medical Device Regulation (MDR): 2020: The Year of Change – Henry Sibun (Henry Sibun Associates Ltd)
14:00 The new ISO 10993-18 Standard and its Impact on Chemical Characterization of Medical Devices – Dr Ted Heise (Vice President Regulatory and Clinical Services at MED Institute)
14:30 Linking ISO 10993-18 to ISO 10993-17 – Dr. Carsten Baun Senholt (ERT Chief Technical Officer at Saxocon)
15:00 Coffee break
15:15 MDR – View of a Raw Materials Supplier - Steve Duckworth (Global Head Marketing and Business Development at Clariant)
15:45 ISO 10993-18 in the MDR: understanding the restrictions and risk assessmentfor compounds which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties (section 10.4) – Dr. Annelies Vertommen (Senior E&L Expert Nelson Labs Europe)
16:15 Tour of the Laboratory Facility
17:00 Networking event
19:00 End of Seminar Day 1
Thursday, March 05, 2020
09:00 Introduction (Nelson Labs Europe)
09:05 MDR – Biocompatibility & reprocessing - Dr Gert Bos (Executive Director & Partner at Qserve)
09:45 The Biological Evaluation Plan (BEP): A crucial first step in the Biocompatibility evaluation of a Medical Device – Dr Sophie Michel (Associate Biocompatibility Expert)
10:15 Competent Authority perspectives on biocompatibility – Dr Pieter Van De Vijver (Non-Clinical Assessor, Medical Devices at FAMHPS)
10:45 Coffee Break
11:15 Assessing Alternatives to In-Vivo testing: Changing the Paradigm from In-Vivo to In-Vitro Toxicology – Dr. Christian Pellevoisin (Scientific Director at Episkin Academy, L’Oréal)
11:45 The need to Identify “Unknowns” from a Risk Management Perspective – Ron Brown (ex-FDA; now Director at Risk Science Consortium LLC)
13:30 How to select a CRO for Chemical Characterization Testing – Dr Dennis Jenke (Principal Consultant Nelson Labs Europe)
14:00 Most Common Types of Observations in Regulatory Submissions of Chemical Characterization Results and how to address them – Dr. Piet Christiaens (Scientific Director at Nelson Labs Europe)
15:00 Intro The Processing Cycle – Henry Sibun (Henry Sibun Associates Ltd)
15:15 Sterilization of your Medical Device – Annick Gillet (Technical Director EO Pharma – Sterigenics)
15:45 Reprocessing Validations of reusable Medical Devices (part 1) – Dr Lise Vanderkelen (Department Head Micro & Pharma Services Nelson Labs Europe)
16:15 Reprocessing Validations of reusable Medical Devices (Part 2) – Alpa Patel, Principal Scientist (Nelson Laboratories LLC)
16:45 Q&A (panel)
17:00 End of Seminar Day 2 – tour of the laboratory facility on-demand
*Times and topics subject to change
Direct link to Nelson Labs Seminar page:
ISO 10993: Are you biocompatible?
Tackle Testing Methods, Evaluations, Risk and Regulations With Competent Authority, Notified Body and Industry Guidance.
Dr Christian Pellevoisin from EPISKIN Academy will do a presentation on November 21st, CCIB, in Barcelona, Spain.
Assessing alternatives to animal testing: Changing the paradigm from in vivo to in vitro toxicology:
- Examining alternative available methods to predict biocompatibility
- Strategies for demonstrating the value of in vitro methods to predict biocompatibility
- Validation of skin irritation on 3D models to replace animal testing
- Latest developments in skin sensitization and perspectives for biomedical devices
- Assessing the need for positive materials with good human data to validate existing assays in vitro
Presentation will be held from 09:10 to 09:45.
If you want to learn more about presentation and book this session you can check website:
Conference on Biocompatibility for Medical Devices US
The EPISKIN Academy, represented by Dr Christian Pellevoisin, will do a presentation during Biocompatibility for Medical Devices US.
October 24, 2019 in JW Marriott Chicago, Chicago, IL, USA.
Examining the latest developments in skin sensitisation and irritation testing:
- Validation of skin irritation on 3D models to replace animal testing
- Assessing how far away the industry is from having positive materials with good human data
- Assessing the need for good human data to validate existing assays in vitro
- Defining the right strategy for sensitisation and irritation testing
- Materials are on the market with no complaints/PMS requirements
Thursday, 24 October 2019 3:15pm - 3:50pm
To read more about the Congress: https://lifesciences.knect365.com
First International Forum on Quality Evaluation of Medical Devices and Biomaterials
The Shandong Medical Device Product Quality Inspection Center held a lecture on the quality and safety evaluation of medical devices and biomaterials and the first international forum on quality evaluation of medical devices and biomaterials to further promote the improvement of the quality evaluation of biomaterials and medical devices, and promote the industry.
The first International Forum on Medical Device and Biomaterial Quality and Safety Evaluation jointly sponsored by Shandong Materials Biology Evaluation Branch and China Biomaterials Society will be held in Jinan, Shandong Province in September 2019.
This forum will bring together experts and scholars from different domestic and international review and approval, inspection and testing, research institutions and industrial enterprises to evaluate the quality of medical devices, focusing on the chemical characterization of medical devices and biological materials, biological evaluation and quality around medical devices.
Safety evaluation related to pre-clinical large animal experiments, integrating the three major cities of production, learning, research, the application of the latest hot topics, research progress and technical difficulties, such as academic reports, experience exchange and technology display.
In order to promote the development of medical device biomaterials quality and safety in the new situation, the new power of the committee will gather in Jinan to participate in the academic event!
September 23-25, 2019: Jinan Yinhuada Hotel ( No.1, Lvxi Caidang, Longxi Road, South Lixia District, E1, 0,531,058,999).
Download Chinese Meeting announcement here.
EPISKIN Academy at the National Conference on Alternatives to Animal Experiments
EPISKIN Academy is invited to give a talk and a pre-conference training to the National Conference on Alternatives to Animal Experiments (NCAAE-2018) that will be held December 1st 2018 in New Delhi (India).
The Conference will be held at Jamia Hamdard, New Delhi, a Deemed to be University accredited in category ‘A’ by the National Assessment and Accreditation Council of India.
This Conference aims to discuss the perspectives on the current state of practices and existing strategies to promote the development of non-animal technologies in India (http://www.jamiahamdard.ac.in/NCAAE2018/NCAAE.htm)
On November 26th, Jamia Hamdard in collaboration with EPISKIN Academy under the aegis of Indian Society for Alternatives to Animal, organize a Hands-on Workshop to train 20 young scientists on Alternatives and in vitro skin Irritation according to OECD TG-439.
EPISKIN at the Eurofins Human Safety Seminar
In Vitro Toxicology at a Glance: Today's Challenges, Solutions & Future Developments
EPISKIN is invited to give a lecture at the Eurofins Human Safety Seminar.
The Seminar will take place on November 29th, 2018 in the new laboratory and office building of Eurofins Munich, Robert-Koch-Straße 3a in Planegg near Munich, Germany.
Dr Pellevoisin, scientific director of EPISKIN Academy will give an overview of eye irritation methods with a focus on OECD TG492 for eye irritation of chemicals in the context of the Guidance Document on an Integrated Approach on Testing and Assessment (IATA) for Serious Eye Damage and Eye Irritation.
The second part of the talk will address the last advancement in skin sensitization testing strategies and added values of reconstructed human epidermis for this endpoint.
Follow this link to learn more about the Eurofins Seminar.
ESTIV 2018 20th International Congress on In Vitro Toxicology
The 20th International Congress on In Vitro Toxicology will be presented from October 15th in Berlin, Germany.
Come and discover the new EPISKIN Academy presentation during the ESTIV congress:
Thursday, ocotber 18th
09.18 (OP 32):
Reconstructed human epithelia for in vitro biocompatibility of medical devices
Pellevoisin Christian (Lyon/FR)
To discover full programme please visit the ESTIV website.
The EPISKIN Academy at the IID 2018
During last IID (International Investigative Dermatology) congress which was held from May 16th to 18th, in Rosen Shingle Creek Resort, Orlando, Florida, the EPISKIN Academy presented two posters about the EPISKIN models:
01156 T-SKIN, a new industrial reconstructed human skin model for dermatological and cosmetics research and development
C. Pellevoisin, D. Lelièvre, M. Bataillon, N. Boyera, A. Rigaudeau, J. Ovigne, I. Besné, N. Seyler
Journal of Investigative Dermatology, Vol. 138, Issue 5, S196
Published in issue: May 2018
01085 Cellular mechanistic investigation on antigen delivery by Viaskin® patch for epicutaneous immunotherapy with reconstructed human epidermis including Langerhans cells (SkinEthicTM RHE-LC)
V. Dioszeghy, C. Pellevoisin, M. Ligouis, F. Sahuc, V. Dhelft, L. Mondoulet
Journal of Investigative Dermatology, Vol. 138, Issue 5, S184
Published in issue: May 2018
EPISKIN ACADEMY poster reward at the 57th SOT
The EPISKIN Academy has been honored by receiving the Best Overall Abstract Award for its poster in Medical Device and combination product speciality section (MDCPSS) presented during the 57th SOT meeting and ToxExpo, in San Antonio, Texas, USA.
This poster is the result of a collaboration between ImmunoSearch, Medtronic and the EPISKIN Academy. It has been written by 3 co-authors: Kelly Coleman (Medtronic), Hervé Groux (ImmunoSearch) and Christian Pellevoisin (EPISKIN Academy).
C. Pellevoisin (EPISKIN Academy), K. Coleman (Medtronic), H. Groux (ImmunoSearch)
Workshop & training session in India
The firth edition of the MGDC-EPISKIN Academy will be held in Mumbai on December 15th-19th.
This 2017 edition, welcomed by the National Facility for Biopharmaceuticals (NFB), coincides with the “1st NATIONAL CONGRESS ON ALTERNATIVES TO ANIMAL TESTING”, a one day conferences co-organized by NFB and EnvisBE.
Because of the recent release of the OECD test guideline 492 for eye irritation, EPISKIN Academy will deliver training 2 sessions: One for Skin irritation according to OECD TG439 and the second for eye irritation according to OECD TG 492.
To learn more about the workshop and training sessions please read the following document:
1st National Congress on Alternatives to Animal Testing - NFB - EPISKIN Academy
To subscribe to the training sessions please use the form below:
REGISTRATION FORM Conference Workshop Alternative Methods
Workshop on 3Rs in Turkey
For the first time EPISKIN Academy will train Turkish scientists to OECD TG439 for in vitro skin irritation of chemicals. This event is co-organized by the TÜBİTAK Marmara Research Center and the CAAT Academy.
EPISKIN Academy in collaboration with local partners share expertise and train young and confirmed scientists to face alternative to animal testing challenges.
3Rs & 2D and 3D Liver, Skin, Eye and Intestinal Regulatory Models. This event is scheduled on November 2 and 3, 2017, at TUBITAK MAM, Gebze - Kocaeli, Turkey.
To learn more about the workshop please follow this link:
Training Session in Rio de Janeiro, Brazil
The first EPISKIN Academy training session in Brazil held in Rio de Janeiro from May 16th to the 17th. It followed the Tissue Engineering day organized by L'Oréal which brought together more than hundred scientists from industry, academics, and governental organizations to discuss the future of this scientific field in Brazil.
During these two days of the training, 8 Brazilian scientists from governmental institutions and industry have been trained to the OECD test guideline 439 for in vitro skin irritation of chemicals with reconstructed human epidermis. This session was hosted by laboratories of the National Institute for Metrology, Quality and Technology (INMETRO). The OECD TG439 is one of the 17 validated alternative methods recommended by the Brazilian Center for Validation of Alternative Methods (BraCVAM) and recognized by the National Council for the Control of Animal Experimentation (CONCEA) to address the ban of animal testing which will enter into force in Brazil in 2019.
The training alternated lectures and hand-on sessions to give both theoretical and practical knowledge to implement and use the results of the TG439. The laboratory session put the trainees in a real situation to assess skin irritation potential of 2 unknown products compared to negative and positive controls with reconstructed tissues, SkinEthic™ RHE tissues, produced in Brazil. The final part of the session has been dedicated to the interpretation and discussion of the experimental results and to certification of the trainees.
Brazil is the third country, after France and China, to produce locally an EPISKIN model. The SkinEthic RHETM model, used during the training, is produced through collaboration between L'Oréal and the Brazilian D'Or Institute for Research and Education (IDOR). EPISKIN, world leader of reconstructed human tissues for 25 years developed a wide range of expertise of applications of these models in different scientific, technological and regulatory contexts for both safety and efficacy purposes. In 2012, EPISKIN Academy have been created to share this knowledge and to prepare next generation of stakeholders to face the challenge of 21st century toxicology. EPISKIN Academy promotes and trains scientists all over the world to alternatives to animal testing in toxicology. To date more than 300 scientists have been trained in Europe, ASIA and America.
To view the video please follow this link: EPISKIN Academy Training Session in Brazil
Inexo Symposium 2017 on Alternative Models
On July 7th, 2017 in Montpellier, France, the EPISKIN Academy will attend the Inexo Symposium 2017 on Alternative Models "in vitro, Ex ovo et Organismes": De la recherche aux applications dans les pathologies et le vieillissement.
Don't miss the EPISKIN ACADEMY presentation about Reconstructed Skin ("Peaux reconstruites") at Amphi B by Dr. Christian Pellevoisin.
To discover the complete scientific program please follow this link: https://inexo-2017.sciencesconf.org/
8th World Congress on Toxicology and Pharmacology
On April 13-15, 2017 in Dubai, UAE, the EPISKIN Academy will attend the 8th Congress on Toxicology and Pharmacology.
Don't miss our keynote session on April, 15th, 2017 that will be held from 09:30 to 10:20: Reconstructed skin models and methods for hazard and risk assessment of chemicals and cosmetics presented byChristian Pellevoisin,
To discover the complete scientific program please follow this link: http://toxicology-pharmacology.conferenceseries.com/scientific-program
EPISKIN ACADEMY AT THE SID 2016 ANNUAL MEETING
The Episkin Academy will attend the SID 2016 Annual Meeting that will be held at the Westin Kierland Resort & Spa in Scottsdale, Arizona, from May 11 to 14, 2016.
'The use of SkinEthic reconstructed human epidermis (RHE) to study immunocompetent cells trafficking and recruitment between skin compartments' will be presented during poster session on Thursday, May 12 and Saturday, May 14.
To learn more about SID annual meeting and scientific program, please follow this link: http://www.sidnet.org/2016annualmeeting
为了进一步通过市场营销来推广重建皮肤模型，欧莱雅（中国）和EPISKN SA 在2014年共同建立了上海斯安肤诺生物科技有限公司，以遵循工业化高质量的标准在中国生产高质量和稳定的重建皮肤模型。EpiSkin模型主要将用于皮肤组织工程和体外试验的研究和检测。此次EPISKIN学院的成立必将在推动工业化生产体外皮肤模型的进程程中扮演举足轻重的角色。
The Episkin Academy at CIFARP
Dr Christian Pellevoisin, Scientific Director of the Episkin Academy, has been invited by the Organizing Committee of CIFARP to be a speaker at 10th Congress of Pharmaceutical Sciences that will be held in Ribeirão Preto – São Paulo -Brazil, from September 06-09, 2015.
This year the theme is “Translating science into health pipeline” :
September 8th - 10:30-12:30 - S9.2: Episkin and the application of reconstructed human 3D models in toxicology and pharmacology.
CIFARP 2015 will be a unique opportunity to discuss the latest trends and scientific breakthroughs in the pharmaceutical sciences field. About 1400 national and international participants are expected, including researchers, professionals, as well as postgraduate and undergraduate students.
For more information consult the website of the congress: http://www.cifarp.com.br/scientific-program.php
Episkin Academy training: ENMV Sidi Thabet- Tunisia, february 23-26, 2015
The National School of Veterinary Medicine Sidi Thabet organized a training in animal experiments which theme was: "From in vivo models to cell models".
This training took place in ENMV of Sidi Thabet (University of Manouba) and lasted 4 days from 23 to 26 February 2015.
34 participants (biology doctoral students, teacher-researchers, veterinarians, industrial and control pharmacists) were informed of the new cell technologies and alternative methods which aim to replace animals in drug-Toxicological, chemical and cosmetics testing. Practical workshops and round table helped to promote exchanges and networking with European partners.
- Promote good practice and ethics in animal experimentation based on the principle of the 3Rs (Replacement, Reduction, Refinement).
- Presentation and training on new cellular technologies (2D and 3D) on two organs: liver and skin (primary liver cells, liver microsome, skin cells ...) in the pharmaco-toxicological and pharmaceutical research.
- Present the situation in Europe and internationally of the new technologies (in silico, in vitro, omics "adverse outcome pathways") in the academic and regulatory (REACH) context.
This training also offers an opportunity to discuss collaborative projects (medium and long term) with the scientific and medical community as well the pharmaceutical industry in the new research program called European "Horizon 2020" and beyond.
The Episkin Academy presented the Pharmacotoxicology applications of the 3D reconstructed human epidermis models during the round table. This presentation was followed by a training session on the use of our epidermal tissues.
||9h00 – 12h00
||14h00 – 17h00
Feb 23, 2015
|- Welcome and registration
- Ethics and Welfare AL
- Guiding principles CIOMS / ICLAS
- Recommendations of the OIE (OIE)
(Ouajdi Souilem, ENMV Sidi Thabet)
Demonstrations on in vivomodels
Team Azal / ENMV / IPT
Feb 24, 2015
|- Place of alternative methods in EA
(Sarrah M'barek, ISSBAT, Tunis)
-Internationally trendof the 3Rs and funding opportunities
(FrançoisBusquet coordinator CAAT, EU, Belgium)
- Zebrafish Model and Applications
(François Busquet, EU Brussels)
REACH and MA Dissemination in Tunisia
Intervention of the Chemistry technical center
Setting up a test platform (François Busquet)
Feb 25, 2015
|- Cell culture: advantages and limits
(Olfa Masmoudi, FST, Tunis)
- In vitro toxicology - pharmacology
(Christophe Chesné, France)
- Applications in pharmacotoxicology of 3D reconstructed human epidermal models
(Christian Pellevoisin, France)
2D models: liver cells
HepaRG BIOPREDIC (Christophe Chesné)
Feb 26, 2015
3D models: skin cell culture
Episkin Academy - Lyon (Christian Pellevoisin)
|Synthesis, debate and Discussion
Distribution of certificates