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progress and controversies : proceedings of the IVth International Congress of Pharmaceutical Physicians = Sécurité et médicament : progrès et controverses : comptes rendus du IVe congrès international des médecins de l'industrie pharmaceutique
International Congress of Pharmaceutical Physicians 1981 : Paris, France)
1 online resource (xviii, 308 pages) : illustrations
Front Cover; Copyright Page; Drug Safety: Progress and Controversies; Table of Contents; PREFACE; ALLOCUTION DE BIENVENUE; Introduction; PART I: DRUG SAFETY: A MULTIFACETED PROBLEM DIVERSITE DES PROBLEMES POSES PAR L'EVALUATION DE LA SECURITE ENMATIERE DE MEDICAAIENTS; Chapter 1. The Scientific Basis of Drug Safety Regulations; HOW CAN DRUG SAFETY BE REGULATED?; DO DRUG SAFETY REQUIREMENTS IMPEDE DRUG INNOVATION?; WHAT IS THE SIGNIFICANCE OF THE BENEFIT-TO-RISR RATIO?; WHERE ARE THE LIMITS OF SAFETY REGULATIONS?; CAN CLINICAL TRIALS BE EXPEDITED WITHOUT NEGLECTING DRUG SAFETY?
HOW CAN THE SCIENTIFIC BASIS OF DRUG SAFETY BE IMPROVED?REFERENCES; Chapter 2. The Effects of Drug Regulation on Iatrogenic Disease; Abstract; A FOLLOW-UP STUDY OF REJECTIONS; A RETROSPECTIVE STUDY OF RESTRICTIVE DECISIONS; MAJOR IATROGENIC ACCIDENTS IN RETROSPECT; EFFICIENCY OF REGULATORY ACTIVITY ON SAFETY MATTERS; OTHER TECHNIQUES; AN INVALID TECHNIQUE; CONCLUSIONS; REFERENCES; Chapter 3. Deregulation of Drug Development: If Effective, Can it be Safe?; Abstract; THE EARLY STAGES : LESS-STHINGENT CONTROL; SEQUENTIAL SUBMISSION AND REVIEW; REALISTIC STANDARDS OF EVIDENCE FOR EFFICACY.
ACCEPTANCE OF FOREIGN AND IRREGULAR DATAIMPROVED ADMINISTRATIVE AND MANAGEMENT TECHNIQUES; POSTMARKETING ISSUES; CONCLUSIONS; REFERENCES; Chapter 4. Les grainds médicaLinents d'hier auraient-ils franchi avec succes le bairrage de la réglementation préclinique actuelle?; Resume; LES COMMISSIONS D'AGREMENT; LE PRIX ET LA DURÉE DES ESSAIS PRÉCLINIQUES; LES LABORATOIRES DE RECHERCHE PHARMACEUTIQUE; QUELQUES DOSSIERS DE GRANDS MEDICAMENTS ANCIENS; CONCLUSIONS; REFERENCES; Chapter 5. The Intemationad Transfer of Information Regarding Drug Saifety : Benefits, Difficulties and Solutions; Abstract.
Chapter 6. Ethicad Considerations in Drug Saifety EvaduationAbstract; CONFLICT OF INTEREST IN RESEARCH; ETHICAL ISSUES IN CLINICAL DRUG TRIALS; THE MARKETING AND USE OF DRUGS; DRUGS IN T H E THIRD WORLD; THE CARE AND FEEDING OF PHARAiACEUTICAL PHYSICIANS; REFERENCES; Chapter 7. A Compairisoii of International Guidelines for the Clinicad Evaduation of Psychotropic Drugs The Price of Safety; Abstract; Chapter 8. USA et FDA Versus CEE et CSP Une etude comparative ouverte des medicaments anti-aingoreux; Resume.
PART II:POST MARKETING SAFETY ASSESSMENT INTERET ET LIMITES DES METHODES D'EVALUATION CLINIQUE DES EFFETS INDESIRABLES DES MEDICAMENTS APRES MISE SUR LE MARCHE: PRESENT METHODSChapter 9. Spontaneous Notification; Abstract; DEFICIENCIES OF PRE-MARKETING TESTS; PRESCRIBING CONDITIONS; ADR REGISTERS IN PMS; ADVANTAGES AND DISADVANTAGES; SPONTANEOUS REPORTING AND IDENTIFICATION OF A NEW HAZARD; RELATIVE RISKS OF VARIOUS DRUGS; ADR'S AND IN-DEPTH STUDIES; WHEN AND WHAT TO REPORT; FEEDBACK OF INFORMATION; CONCLUDING REMARKS; REFERENCES.
editors, Michel Auriche, John Burke, Jacques Duchier.
"The 4th International Meeting of Pharmaceutical Physicians."--Page vii
International Congress of Pharmaceutical Physicians (4th : 1981 : Paris, France).