Drug safety : 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 pharm

Content: Front Matter , Page III Copyright , Page IV LE IV e CONGRES DES MEDECINS DE L'INDUSTRIE PHARMACEUTIQUE THE 4 th INTERNATIONAL MEETING OF PHARMACEUTICAL PHYSICIANS , Page VII PREFACE , Pages XIII-XIV , R.K. RONDEL Dedication , Page XV ALLOCUTION DE BIENVENUE , Pages XVII-XVIII , Michel AURICHE Introduction , Pages 1-5 , M. AURICHE The Scientific Basis of Drug Safety Regulations , Pages 9-18 , F.H. GROSS The Effects of Drug Regulation on Iatrogenic Disease , Pages 19-31 , M.N.G. DUKES, I. LUNDE Deregulation of Drug Development: If Effective, Can it be Safe? , Pages 33-40 , W.M. WARDELL Les grands médicaments d'hier auraient-ils franchi avec succès le barrage de la réglementation préclinique actuelle? , Pages 41-50 , P. DUCHENE-MARULLAZ The International Transfer of Information Regarding Drug Safety: Benefits, Difficulties and Solutions , Pages 51-53 , J.F. DUNNE Ethical Considerations in Drug Safety Evaluation , Pages 55-62 , Michael P. HAMILTON A Comparison of International Guidelines for the Clinical Evaluation of Psychotropic Drugs The Price of Safety , Pages 63-66 , V. H. VAN LANDEGHEM USA et FDA Versus CEE et CSP Une étude comparative ouverte des médicaments anti-angoreux , Pages 67-70 , J.R. ESPIE Spontaneous Notification , Pages 73-82 , J.E. IDÄNPÄÄN-HEIKKILÄ Assessment of the Cause and Effect Relationship of Suspected Adverse Drug Reactions , Pages 83-91 , J. VENULET, A.G. Ciucci Experiences of Registers in Drug Safety Assessment in Sweden , Pages 93-103 , B. WESTERHOLM, B.E. WIHOLM Méthodes actuelles pour évaluer l'innocuité des médicaments: enquêtes prospectives , Pages 105-110 , C. RUMEAU-ROUQUETTE Case-Control Studies in the Evaluation of Drug Safety , Pages 111-121 , M.P. VESSEY Hospital Surveys , Pages 123-125 , H. JICK Cost and Effectiveness of Post-marketing Surveillance , Page 127 , P.E. LUCCHELLI Scientific Obstacles to Overcome in Establishing Systematic Post-marketing Surveillance , Page 131 , K.L. MELMON Cohorts From Data Banks , Pages 133-135 , H. JICK The Drug Surveillance Research Unit (DSRU) , Pages 137-142 , W.H.W. INMAN Post-marketing Safety Assessment New Zealand Experience , Pages 143-150 , J.S. PHILLIPS Post-marketing Surveillance in U. K.: A Study of Cimetidine Recipients , Page 151 , P.H. LAWSON Post-marketing Surveillance Experience Gained with an Orally Active Asthma Prophylactic Agent , Page 153 , P. KRUPP, D. CROWDER La sécurité passe par l'information sur le médicament. Role du médecin de l'industrie pharmaceutique , Pages 155-159 , J.F. SCHLUMBERGER The Liability of Manufacturers in Respect of Known Effects of Medical Products , Pages 163-167 , G.C. TUCK La responsabilité stricte des laboratoires pour tous les risques même imprévisibles , Pages 169-175 , F. MARTEL The Physician's Labeling — An American Point of View , Pages 177-182 , L.G. MILLSTEIN Drug Safety — Information Systems , Page 183 , J. CROOKS Future Systems in Providing the Prescriber with Drug Information , Pages 185-187 , H. DUCROT Rôle du prescripteur dans l'information du patient sur les effets du médicament , Pages 189-192 , P. GUILLET Pharmacist Contribution to Patient Information and Drug Safety , Pages 193-198 , J.R. WUEST The Patient Package Insert The FDA Concept and Plans , Pages 199-205 , L.G. MILLSTEIN Evaluation de l'observance , Pages 207-212 , E. WEBER Cross Culturad Problems with Regard to Product Information and Drug Safety , Pages 213-220 , L.A. SALAKO Product Information: Proposal for a Coherent Action Program , Pages 221-225 , A. HERXHEIMER A Diploma Course in Pharmaceutical Medicine , Page 229 , B.T. MARSH, D.K. LUSCOMBE Diploma in Pharmaceutical Medicine (D.P.M.): A survey of Attitudes of A.M.A.P.I. members. , Page 231 , R.P. BAX, D. McCULLEY Test of Small Airways Function in Monitoring Respiratory Effects of Medicinals , Page 233 , B.M. COHEN Algorithms and the Science of Systematic Drug Development , Page 235 , F.W. WOLFF Management of Clinical Triads in Developing Countries , Pages 237-245 , E.W.J. DE MAAR The Pathologist's Role in the Interpretation of Carcinogenicity Studies on Laboratory Animals , Page 247 , J.M. FACCINI Methodological Problems in the Detection and Evaluation of Adverse Events during the Phases I, II and III of the Drug Development , Page 249 , L. Bossi, J.F. HENRY, M. VADROT Post-marketing Surveillance in Italy: A Comparison between Firm-sponsored and Independent Trials with Prazosin , Pages 251-255 , V. FORTE, M. CIAMPINI Current Concepts for Assessing the Drug Adverse event Relationship and their Problems , Pages 257-262 , J. HASFORD Methodological and Statistical Problems in the Evaluation of Data on Adverse Drug Reaction , Page 263 , J. SCHERER, A. STRAUSS Post-marketing Surveillance Methodology as Applied in a Pharmaceutical Medical Department , Pages 265-273 , A. EMANUELI, G. SACCHETTI Cimetidine as a Model for Post-marketing Safety Assessment , Page 275 , A.C. FUND, D. ROWLEY-JONES Improving Drug Compliance in a Multi-cultural Multi-linguistic Society , Page 277 , P.S. TALBOT, L.D. BECKWITH 1984 and the Committee on Safety of Surgery , Page 279 , D.M. BURLEY Adverse Drug Reaction Monitoring in Psychiatric Hospitals , Pages 281-285 , R. GROHMANN A Post-marketing Surveillance Study on Bacampicillin , Pages 287-290 , P.G. PRELLA, M. CIAMPINI, E. MICHELETTI Post-marketing Surveillance: Computerized Evaluation of Side Effects , Pages 291-300 , U. QUAST CNS Safety Evaluations of New Drugs Based on Computerized Bio-electrical Potentials , Page 301 , T.M. ITIL, D.M. SHAPIRO, G.N. MENON, K.Z. ITIL ALLOCUTION DE CLOTURE , Page 303 , Michel AURICHE TABLE OF SPEAKERS , Pages 305-308 Inside Back Cover , Page 310