Vidal Benatar and Paricia Nury : clinical development programmes and protocols, regulatory strategies, registration dossier, pediatric investigation plans, therapeutic added value, pricing and market access, publications.
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Vidal Benatar
111, rue●●●●●●●●nerolles
sain●●●●oud, , 92210
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Kiner David
126 rue●●●●●●●s Aufan
Leval●●●●●erret , 92300
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Kiner David
126 rue●●●●●●●s Aufan
Leval●●●●●erret , 92300
FR
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Heathics: Consultants to pharmaceutical industry | heathics.com Reviews
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Vidal Benatar and Paricia Nury : clinical development programmes and protocols, regulatory strategies, registration dossier, pediatric investigation plans, therapeutic added value, pricing and market access, publications.
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Consultants to Pharmaceutical industry , advisory
http://www.heathics.com/drug-industry-consultant.php?langue=en
Drug safety and pharmacovigilance. Paediatric investigational plans (PIP). Scientific support to market access. We offer consultancy services adapted to your needs at all steps of drug development, including on occasional issues. Our quality requirement, our availability and our listening capabilities will make emerge relevant solutions that will support your decision-making process. Do not hesitate in questioning us. 111, rue des Tennerolles - 92210 Saint Cloud, France. Phone/Fax : 33 (0)1 46 02 19 30.
International clinical development
http://www.heathics.com/clinical-development-study-trial-consultant.php?langue=en
Drug safety and pharmacovigilance. Paediatric investigational plans (PIP). Scientific support to market access. We assist you in developing such plans with adequate methodological, academic and logistical support with the purpose of best documenting the medicinal product therapeutic added value. We organise trials scientific management with supportive boards of experts: Executive and/or Steering Committees, Data and Safety Monitoring Committees, Endpoint Validation Committees and corresponding charters.
Values and principles
http://www.heathics.com/pharmaceutical-industry-consultant.php?langue=en
Drug safety and pharmacovigilance. Paediatric investigational plans (PIP). Scientific support to market access. We are orientated towards our client s needs and we create a synergistic partnership. We adapt our intervention to our client s structure and organisation. We do not substitute ourselves to our client s professionals. We focus on unmet medical needs, patient benefit and therapeutic added value. We take into account the changing medical, regulatory and competitive environment.
The team
http://www.heathics.com/pharmaceutical-laboratory-consultant-team.php?langue=en
Drug safety and pharmacovigilance. Paediatric investigational plans (PIP). Scientific support to market access. Patricia Nury graduated from the Medical School of Paris, France. After 5 years of clinical practice in Internal Medicine and Geriatrics, she joined the Pharmaceutical Industry where she acquired nearly 20-year experience in New Drug Development with focus on Clinical Research, Global Project Management and Regulatory Strategy for Cardiovascular and Central Nervous System medicines.
Scientific support to drug market access
http://www.heathics.com/medical-market-access-support.php?langue=en
Drug safety and pharmacovigilance. Paediatric investigational plans (PIP). Scientific support to market access. Academic endorsement and support, optimal public price and effective promotional strategies are key components of commercial success. We assist you in developing scientific communication plans with selected experts and Key Opinion Leaders (KOLs). This includes medical writing for abstracts and manuscripts for publication in appropriate journals. Phone/Fax : 33 (0)1 46 02 19 30.
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Stratégie Santé; votre partenaire en affaires réglementaires, gestion de projets et transactions
http://strategiesante.com/eCTD.php
Basic and Advanced PK Workshop. Your partner in CTD and eCTD files - Variations - Risk Management Plan - Environmental Risk Assessment - PIL user testing - CEP and ASMF applications - National and DCP MAs - MA Holding - MA Transfer - ICH Q3D Risk analysis - Reimbursement and prices - Market access studies. Découpage et formatage du dossier. Conversion des fichiers au format requis. Compilation des fichiers dans une structure eCTD. Préparation de la publication électronique draft. Agrave; vos prescripteurs.
Stratégie Santé votre partenaire en affaires rĂŠglementaires, gestion de projets et transactions
http://strategiesante.com/pharmacokinetic-form.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. KEY TOPICS IN PHARMACOKINETICS IN DRUG DEVELOPMENT. Paris – France. STRATEGI...
Stratégie Santé - Regulatory affairs
http://strategiesante.com/affaires-reglementaires.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. En tant qu’interlocuteur autorisé par nos clients. Définition de la stratégi...
Stratégie Santé Pharmacokinetic presentation
http://strategiesante.com/pharmacokinetic-presentation.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. PHARMACOKINETIC WORKSHOP - PROGRAM. 17th – 19th October 2016. This intermedi...
Stratégie Santé - Audits
http://strategiesante.com/audits.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. Audits de fournisseurs d’API et d’excipients pharmaceutiques. Ces stages per...
Stratégie Santé; votre partenaire en affaires réglementaires, gestion de projets et transactions
http://strategiesante.com/qui-sommes-nous.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. Dr en Pharmacie, Master de Pharmacotechnie et Biopharmacie, est spécialisée ...
Stratégie Santé; votre partenaire en affaires réglementaires, gestion de projets et transactions
http://strategiesante.com/pharmaceutical-news.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. ANSM : Agence nationale de sécurité du médicament et des produits de santé -.
Stratégie Santé - Développement pharmaceutique
http://strategiesante.com/developpement-pharmaceutique.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. DÉVELOPPEMENT PHARMACEUTIQUE ET GESTION DE PROJETS. Agrave; vos prescripteurs.
Stratégie Santé - Conseils
http://strategiesante.com/conseils.php
Basic and Advanced PK Workshop. Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Test de lisibilité - Dossiers CEP et ASMF - AMM DCP - MRP et Nationales - Portage d'AMM - Transfert d'AMM - ICH Q3D Analyse de risque - Dossiers remboursement et prix - Notes d'intérêt thérapeutique – Etudes de market access. Aide à la décision avant acquisition de produits ou dossiers. Agrave; vos pr...
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Heathics: Consultants to pharmaceutical industry
Drug safety and pharmacovigilance. Paediatric investigational plans (PIP). Scientific support to market access. Solutions in Drug Development. As consultants to the pharmaceutical industry, our role is to advise you and to assist you in achieving the most efficient regulatory and product lifecycle strategies from discovery to market place, throughout each of the development phases. 111, rue des Tennerolles - 92210 Saint Cloud, France. Phone/Fax : 33 (0)1 46 02 19 30.
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