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See detailL'harmonisation des statuts entre ouvriers et employés
Baukens, Michèle; Rozenberg, Fanny ULg; Kéfer, Fabienne ULg

Book published by Anthemis (2014)

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See detailHarmonisation des strategies de validation et estimation de l'incertitude associee dans le cadre de l'accreditation des laboratoires d'essais
Hubert, Philippe ULg; Rozet, Eric ULg; Boulanger, Bruno ULg et al

in Acta Clinica Belgica. Supplementum (2006), S1(1), 53-55

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an ... [more ▼]

In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an analytical procedure is described: the accuracy profile based on the estimation of the total error of the measurements. This profile build with beta-expectation tolerance intervals can also compute with efficiency the uncertainty related to the results of a laboratory, which is an essential parameter for the accreditation of laboratories under ISO 17025. [less ▲]

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See detailHarmonisation du droit de la construction et protection du consommateur
Kohl, Benoît ULg

Scientific conference (2008, May 08)

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See detailHarmonisation et construction
Kohl, Benoît ULg

Article for general public (2009)

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See detailHarmonisation of Construction Liabilities in the European Union
Kohl, Benoît ULg

Conference (2013)

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See detailHarmonisation of European Construction Law : Consumers First
Kohl, Benoît ULg

Conference (2008, September 04)

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See detailHarmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - part I
Hubert, Philippe ULg; Nguyen-Huu, J.-J.; Boulanger, Bruno ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2004), 36(3), 579-586

This paper is the first part of a summary report of a new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP). The main objective of this commission was the ... [more ▼]

This paper is the first part of a summary report of a new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP). The main objective of this commission was the harmonization of approaches for the validation of quantitative analytical procedures. Indeed, the principle of the validation of theses procedures is today widely spread in all the domains of activities where measurements are made. Nevertheless. this simple question of acceptability or not of an analytical procedure for a given application, remains incompletely determined in several cases despite the various regulations relating to the good practices (GLP, GMP,...) and other documents of normative character (ISO, ICH. FDA,...). There are many official documents describing the criteria of validation to be tested, but they do not propose any experimental protocol and limit themselves most often to the general concepts. For those reasons, two previous SFSTP commissions elaborated validation guides to concretely help the industrial scientists in charge of drug development to apply those regulatory recommendations. If these two first guides widely contributed to the use and progress of analytical validations, they present, nevertheless, weaknesses regarding the conclusions of the performed statistical tests and the decisions to be made with respect to the acceptance limits defined by the use of an analytical procedure. The present paper proposes to review even the bases of the analytical validation for developing harmonized approach, by distinguishing notably the diagnosis rules and the decision rules. This latter rule is based on the use of the accuracy profile, uses the notion of total error and allows to simplify the approach of the validation of an analytical procedure while checking the associated risk to its usage. Thanks to this novel validation approach, it is possible to unambiguously demonstrate the fitness for purpose of a new method as stated in all regulatory documents. (C) 2004 Elsevier B.V. All rights reserved. [less ▲]

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See detailHarmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part II
Hubert, Philippe ULg; Nguyen-Huu, J.-J.; Boulanger, Bruno ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2007), 45(1), 70-81

As reported in a previous paper[1], the main objective of the new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of approaches for the ... [more ▼]

As reported in a previous paper[1], the main objective of the new commission of the Societe Francaise des Sciences et Techniques Pharmaceutiques (SFSTP) was the harmonisation of approaches for the validation of quantitative analytical procedures. In a series of meetings, members of this Commission have first tried to review the objectives of analytical methods and the objectives of validation methods and to recommend the use of two-sided beta-expectation tolerance intervals for total error of validation samples (accuracy profile) in the acceptance/rejection of analytical method in validation phase. In the context of the harmonization, the other objectives were: (i) to propose a consensus on the norms usually recognized, while widely incorporating the ISO terminology; (ii) to recommend to validate the analytical procedure accordingly to the way it will be used in routine; (iii) to elaborate a rational, practical and statistically reliable strategy to assure the quality of the analytical results generated. This strategy has been formalised in a guide and the three latter objectives made by the Commission are summarised in the present paper which is the second part of summary report of the SFSTP commission. The SFSTP guide has been produced to help analysts to validate their analytical methods. It is the result of a consensus between professionals having expertise in analytical and/or statistical fields. The suggestions presented in this paper should therefore help the analyst to design and perform the minimum number validation experiments needed to obtain all the required information to establish and demonstrate the reliability of its analytical procedure. (C) 2007 Elsevier B.V. All rights reserved. [less ▲]

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See detailHarmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III
Hubert, Philippe ULg; Nguyen-Huu, J. J.; Boulanger, Bruno ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2007), 45(1), 82-96

In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg. M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L ... [more ▼]

In the first two documents [Ph. Hubert, J.J. Nguyen-Huu, B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg. M. Lallier, M. Laurentie, N. Mercier, G. Muzard, C. Nivet, L. Valat, J. Pharm. Biomed. Anal. 36 (2004) 579-586; Ph. Hubert, J.J. Nguyen-Huu. B. Boulanger, E. Chapuzet, P. Chiap, N. Cohen, P.A. Compagnon, W. Dewe, M. Feinberg, M. Lallier, M. Laurentie, N. Mercier, G. Muzard. C. Nivet, L. Valat, E. Rozet, J. Pharm. Biomed. Anal., in press], a recent SFSTP Commission on the validation of analytical procedure has introduced a harmonized approach for the validation of analytical procedures. In order to complete this guide, the statistical methodology allowing to correctly conclude about the validity of a procedure is proposed in this third part of the guide. Indeed all the steps to obtain the decision tool namely the accuracy profile are described and illustrated step by step by a numerical example. This tool, based on the concept of total error (bias + standard deviation) build with a P-expectation tolerance interval, allows to easily take the right decision and simultaneously minimizing the risk of the future use of the analytical procedure. (C) 2007 Elsevier B.V. All rights reserved. [less ▲]

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See detailHarmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal part IV. Examples of application.
Hubert, Philippe ULg; Nguyen-Huu, J.-J.; Boulanger, Bruno ULg et al

in Journal of Pharmaceutical & Biomedical Analysis (2008), 48(3), 760-71

A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This fourth and last document aims ... [more ▼]

A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This fourth and last document aims at illustrating this methodology and the statistics used. Therefore the validation of real case methods are proposed such as methods for the quality control of drugs, for the quantitation of impurities in drug substances, for bioanalysis or for the determination of nutriments. Furthermore, different types of analytical methods are used in order to demonstrate the applicability of the proposed approach to a wide range of methods such as liquid chromatography (LC-UV, LC-MS), spectrophotometry or ELISA. [less ▲]

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See detailHarmonization of the Law of Succession in Europe
Leleu, Yves-Henri ULg; Verbeke, Alain-Laurent

in Hartkamp, S.; Hesselink, M.W.; Hondius, E. (Eds.) et al Towards a European civil Code (2010)

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See detailHarmonization of the Law of Succession in Europe
Leleu, Yves-Henri ULg; Verbeke, Alain

in Hartkamp, A. (Ed.) Towards a European Civil Code (2004)

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