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Votre partenaire en dossiers CTD et eCTD - Développement Pharmaceutique - Gestion de Projets - Variations - Plan de Gestion du Risque - Evaluation du Risque Environnemental - Dossier Préclinique et Clinique - 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" - Conseil et plan d'action Qualité - Qualification et Validation - Coaching et Communication - Formations BPF Personnels
 
 
PHARMACOKINETIC WORKSHOP - PROGRAM
 
A 3-day intermediate level Workshop using a top-down approach with a strong mechanistic emphasis. This intermediate level workshop is designed for those engaged in pharmacokinetic studies in drug discovery, development and regulatory assessment, who already have a good working knowledge and understanding of the basic physiological and mathematical concepts and applications in the subject area, for example, who have taken the Basic Pharmacokinetic Workshop, Arosa.
 
 


The workshop, under the scientific guidance of Professors Malcolm ROWLAND, comprises lectures delivered in English, supplemented by small workshop sessions (about 12 per group). The workshop sessions reinforce the lectures through problem solving.
 
  Scientific guidance
 
Malcolm ROWLAND
Professor Emeritus of Pharmacy

University of Manchester

   
 
 
PHARMACOKINETIC WORKSHOP - PROGRAM
 
  For whom intended
This intermediate level workshop is designed for those engaged in pharmacokinetic studies in drug discovery, development and regulatory assessment, who already have a good working knowledge and understanding of the basic physiological and mathematical concepts and applications in pharmacokinetics.
  For what purpose
To provide a deeper understanding of selected topics in pharmacokinetics to help in protocol design and evaluation during preclinical and clinical development.
  Course schedule
 
Important: Please note that the program taken by all participants runs from Wednesday morning to Friday afternoon, but arrival of participants is scheduled on Tuesday evening at the hotel.
 
 
Tuesday 10th evening
Arrival
Wednesday 11th : 8h30-18h00
Review of basic concepts in pharmacokinetics
Transporters
Thursday 12th : 9h00-18h00
Drug-drug interactions
Metabolite kinetics
Friday 13th : 9h00-15h30
Preclinical prediction of human pharmacokinetics
Bioavailability and Bioequivalence
 
 
  Location
Villa Modigliani – 13, rue Delambre – 75014 Paris - Phone 33(0)1 56 54 20 00 - www.villa-modigliani.fr
Villa Modigliani hotel is located in the heart of Montparnasse, the ''artists quarter of Paris'', very close to some stylish places as The Dome, The Cupola, the Cafe Edgard, the Gaiety Theater Montparnasse, the ''Petit Journal'' Jazz Club.
You can reach the hotel from airport CDG or Orly by bus shuttle or RER/Tube (stations Edgard Quinet - line 6, Vavin – line 4, Montparnasse – Lines 4,6, 12 and 13).
You can also reach the hotel by train TGV or Thalys, to any train station of Paris, then RER/tube. The nearest train station is Montparnasse (5 mn walking).
Fees
Up to 2017, June 30th : 3 700 € including local taxes
After 2017, June 30th (+15%) : 4 255 € including taxes
This fee include :
Local taxes. No VAT required according to CGI Art. 261.4.4. alinea 6
Lodging at Villa Modigliani hotel (through the nights of October 10th to 12th), course registration, course notes, breakfast, morning and afternoon coffee breaks, lunch.
This fee does not include :
Tuesday, Wednesday and Thursday dinner.
Be carefull: if you register after September 15th we cannot guarantee that you will be lodging at Villa Modigliani Hotel. In that case you will be lodged at another hotel.
 
 
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BIOWAIVERS WORKSHOP
Séminaire de 2 jours utilisant une approche pragmatique. Ce séminaire de niveau intermédiaire est conçu pour les personnes qui ont déjà une certaine connaissance du développement pharmaceutique et des aspects réglementaires de l'enregistrement des dossiers. Il est destiné aux personnes des services Affaires réglementaires, Développement galénique, Développement clinique, ainsi que Gestion de projets et Business developpement.
28 - 29 SEPTEMBRE 2017
Villa Modigliani - Paris – France
Plus de détails...
FOCUS ON...
PHARMACOKINETIC WORKSHOP
A 3-day intermediate level Workshop using a top-down approach with a strong mechanistic emphasis. This intermediate level workshop is designed for those engaged in pharmacokinetic studies in drug discovery, development and regulatory assessment, who already have a good working knowledge and understanding of the basic physiological and mathematical concepts and applications in the subject area, for example, who have taken the Basic Pharmacokinetic Workshop, Arosa.
11th – 13th October 2017
Villa Modigliani - Paris – France
More detail...
FORMATION CONTINUE
La formation continue, une activité stratégique pour accompagner les entreprises.
L’EBI met à disposition des chefs d’entreprise une offre variée de formations.
Ces stages permettent de développer les compétences de leurs salariés dès le niveau technicien dans les domaines d’expertise de l’EBI : biotechnologie, procédés industriels, formulation, analyse sensorielle, marketing, …
Formations inter-entreprises : l’EBI propose tout au long de l’année des stages d’une ou deux journées (catalogue disponible sur notre site internet).
Formations intra-entreprise : selon les besoins spécifiques de l’entreprise, l’EBI accompagne les entreprises dans l’élaboration de formations sur mesure permettant ainsi de former en interne un petit groupe sur un thème ciblé.
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