Institutional enterprises (IEs) can be individuals, organisations or professions (professional networks, associations, social movements, professional communities, clubs, etc.). They are characterized by their ability to break with established patterns of behaviour and take reflexive positions to change the institutional environment (DiMaggio, 1988; Dorado, 2005; Hardy and Maguire, 2008; Leca and Naccache, 2006).
These are actors whose aim is to change the rules of the game by translating practices, existing beliefs and models (Leca and Naccache, 2006).
The work of institutional creation corresponds to the implementation of new practices, new rut and new standards. This work covers operations aimed both at ensuring legitimacy to these new practices against stakeholders. However, their recognition “leads them to confront the paradox of the embedded agent (action located) in its institutional environment” (Leca and Naccache, 2006).
The role of standards contractors, institutional contractors.
From a constructivist perspective, however, norms are seldom imposed on States by the force of their intrinsic legitimacy. The role of “standards entrepreneurs” is seen as decisive, whether international organizations, NGOs or other transnational networks.
Margaret Keck and Kathryn Sikkink highlighted the role of cross-advocacy networks (transnational advocacy networks) composed of actors from NGOs, social movements, foundations, media, churches, trade unions, intellectuals, international organizations and governments (Keck and Sikkink, 1998).
The two authors show in particular how, in authoritarian States, the without means of expression in the face of their government are coalescing with networks transnational organizations that support their cause.
Authoritarian governments are therefore subject to international pressure ("boomerang”effect of their policy of repression) which redoubles the effect of internal mobilization, with the objective of inflecting the attitude of these governments and of internalizing them new democratic norms.
In the more or less long term, authoritarian regimes would thus be led to convert to norms relating to human rights, under the effect of a double normative, internal pressure and international.
The Oviedo Convention: protecting human's rights in the biomédical field
The National Conference of Human Protection Committees (CNCP)
The CPPs mission is to give an opinion on research projects involving the human person (RIPH) with regard in particular to the protection of research participants. The opinion of the CCPPRB was advisory, the opinion of the CPPs is authorised, that is to say that the research cannot be undertaken in case of adverse opinion of a CPPC.
In addition, CPP are asked to provide advice on plans to use human body elements and products for scientific purposes during RIPH or subject to a change of purpose.
The composition of CPP, the appointment of members, the organization and operation of the structure, and the notification procedure are defined in the Public Health Code
The Committees and an operating autonomy in compliance with the laws and regulations.
The members of the first CCPPRB, set up in 1991, and in particular their Presidents, have wished, since 1992, to meet within a National Conference of Protection Committees (CNCP), created sui generis.
28th national conference of the research ethics committees
19, 20, 21 JUIN 2019
University of Pharmacy, Montpellier.
inscriptions on weezevent:
Academic & Industrial Development in Clinical Research & Information System (RBM oriented)
Promotion of new approach in Risk Based Monitoring, Pharmacovigilance and Surveillance.
Clinical Expertise, Legal representation and for cause monitoring.
Experts in clinical development of the products of health. We insure the monitoring of clinical trials, with respect with the hiegher standards regulations in force.
Designers of information systems for the research and development in health.
Preparing submissions to RA/EC (or submitted documents to RA/EC) .
Managing Financial aspects of the trial (contract with investigators and Institution).
Training CRA / CTA.
Project Planification and manpower managment Training and conference in core business French ANSM personal Training at LNE-G.Med, notified body in France
Type of Study Dates Range of Responsibilities.
Opthalmology (Device), for a german manufacturer 2016-2017 Clinical Development Program Consultancy in France
Neurology (Phase IIIb) – French Pharma. 2014-2017 OnSite Monitoring France
Oncology-Biotech (Phase III) for an US company 2014-2015 Sponsor’s epresentative in France
Recent accidents have raised public awareness regarding the need for transparency and safety in the evaluation of health products. The case of VIOXX® can be identified as the most representative industrial, global, contemporary pharmaceutical accident similar to that of thalidomide in 1953 and Distilbene in 1977.
The works presented in this chapter focus on one of current societal issues: how can the quality and the safety of health products available on the market be guaranteed to every citizen? This topic is directly related to the notion of pharmacovigilance and in the broader sense that of surveillance and strategic foresight (SF).