Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety (notice n° 603604)
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| fixed length control field | 03089cam a2200361 4500500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250121154859.0 |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | fre |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | dc |
| 100 10 - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Ribet, Virginie |
| Relator term | author |
| 245 00 - TITLE STATEMENT | |
| Title | Surveillance of dermo-cosmetic products: a global cosmetovigilance system to optimise product development and consumer safety |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Date of publication, distribution, etc. | 2021.<br/> |
| 500 ## - GENERAL NOTE | |
| General note | 73 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Background. In the absence of formal marketing authorisation, the manufacturers of cosmetic products are responsible for their compliance with the cosmetic regulations. Objectives. To present the key features of a structured, reactive, and rigorous global cosmetovigilance system through practical examples. Materials & Methods. During clinical development, adverse reactions are collected formally and analysed by cosmetovigilance experts. After commercialisation, information on reported adverse reactions is sought directly from the consumers. The results of allergological investigations are systematically requested. Pre- and post-marketing cases are analysed along with other sources of information (e.g. monitoring of the literature) to detect safety signals per product and per ingredient. A cosmetovigilance index (CVI) is calculated for each formula, based on the number of cases, causality level and number of commercialised units. Updated periodically, it is used to detect signals and select the best tolerated formulas to help formulating new products. Results. Examples of safety issues raised during development or after commercialisation, and corresponding corrective actions, are presented. These actions include (but are not limited to) a safety watch to closely monitor adverse reactions, the modification of the formula or a change in the packaging. Cosmetovigilance data also impact future product development, as illustrated by the work done on sunscreens. Conclusion. Through the rigorous collection and analysis of adverse reactions during development and after commercialisation, the safety of dermo-cosmetic products can be improved by taking the appropriate corrective actions, monitoring their effectiveness and optimising future product development by focusing on the best tolerated formulas. |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | adverse skin reaction |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | allergy |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | signal detection |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | undesirable effect |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | dermato-cosmetics |
| 690 ## - LOCAL SUBJECT ADDED ENTRY--TOPICAL TERM (OCLC, RLIN) | |
| Topical term or geographic name as entry element | patch test |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Albinet Claudin, Laure |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Brinio, Elsa |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Berthier, Amélie |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Millet, Violaine |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Halbeher, Clémence |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Sauvaire, Laure |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Laborderie, Marylaure |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lafosse, Simon |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Olivan, Audrey |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Giordano Labadie, Françoise |
| Relator term | author |
| 700 10 - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Ferret, Pierre-Jacques |
| Relator term | author |
| 786 0# - DATA SOURCE ENTRY | |
| Note | European Journal of Dermatology | 31 | 4 | 2021-07-01 | p. 463-469 | 1167-1122 |
| 856 41 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://shs.cairn.info/revue-european-journal-of-dermatology-2021-4-page-463?lang=en&redirect-ssocas=7080">https://shs.cairn.info/revue-european-journal-of-dermatology-2021-4-page-463?lang=en&redirect-ssocas=7080</a> |
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