Title of article
Post Launch Monitoring of food products: What can be learned from pharmacovigilance
Author/Authors
van Puijenbroek، نويسنده , , E.P. and Hepburn، نويسنده , , P.A. and Herd، نويسنده , , T.M. and van Grootheest، نويسنده , , A.C.، نويسنده ,
Issue Information
روزنامه با شماره پیاپی سال 2007
Pages
8
From page
213
To page
220
Abstract
Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever’s Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of ‘signals’ of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.
Keywords
Post Launch Monitoring , Post Marketing Surveillance , Novel foods , Pharmacovigilance , Causality assessment
Journal title
Regulatory Toxicology and Pharmacology
Serial Year
2007
Journal title
Regulatory Toxicology and Pharmacology
Record number
1487955
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