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DTSTART:20040328T010000
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DTSTART:20041031T010000
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DTSTART;VALUE=DATE:20040229
DTEND;VALUE=DATE:20040303
DTSTAMP:20260929T023031
CREATED:20190315T013414Z
LAST-MODIFIED:20190613T203040Z
UID:3120-1078012800-1078271999@dev.agah.eu
SUMMARY:13th AGAH Annual Meeting 2004
DESCRIPTION:  \nSpecial Populations: what makes them so special? Current issues in study design\, evaluation and regulatory affairs during drug development\n\n\n\n	Announcement \n\n\n\nFebruary 29 – March 2\, 2004\, Schering AG\, Berlin\nThe Annual Meeting 2004 focussed on current issues in human pharmacology research in special populations such as children\, women\, elderly\, ethnic groups\, but also special patients groups such as patients with chronic renal failure\, diabetics etc. \nAdditional workshops dealt with actual topics such as the upcoming implementation of the European trial directive into German law. \n\n\n\n\n\n\n\n	Congress Information \nDate:\n29.02.-02.03.2004 \nConference venue:\nBerlin\, Schering AG \nProgramme Committee:\n• Kerstin Breithaupt-Grögler\, Frankfurt\n• Ulrike Ebert\, Universität Heidelberg\n• Charlotte Herrlinger\, 4SC\, Martinsried\n• Carsten Meyerhoff\, Health Management Consulting\, Langenau\n• Berno Müller\, Pharmacon\, Berlin\n• Anne-Kathrin Riethling\, Universität Rostock\n• Bernd Rosenkranz\, Jerini\, Berlin\n• Tomas Salmonson\, Medicinal Products Agency\, Uppsala\n• Meinolf Wonnemann\, SocraTec R&D\, Oberursel\n• Michael Zühlsdorf\, Bayer\, Wuppertal \nOrganisational Committee:\n• Wolf Sittner\, Schering\, Berlin\n• Amira Skapur\, SocraTec R&D\, Oberursel\n• Yvonne Spiegel\, Schering\, Berlin\n• Thomas Staks\, Schering\, Berlin\n• Marianne Weiß\, Schering\, Berlin \n  \n\nCosts:\n400 Euro after January 1\, 2004\n25 Euro reduction for AGAH-\, ACCP-\, and Club-Phase-I-Members\n100 Euro participation on Sunday only\n250 Euro for junior scientists below 30 years of age (limited numbers only)\n150 Euro for junior poster presenters below 30 years of age\n\n  \n\n\n\n\n	Day 1\, Sunday\, 29.02.2004  \n\n10:00 - 13:30 \n12. AMG Novelle – aktueller Stand Phase-I-Studien im neuen regulatorischen Umfeld\nI. Klingmann\, Pharmaplex\, Brüssel; H. Fuder\, Parexel\, Berlin \n\n10:00 \nWillkommen und Einleitung\nI. Klingmann\, Brüssel \n\n10:10 \nEuropäische Hintergründe der Richtlinie 2001/20/EG\nB. Lehmann\, European Commission\, Brüssel \n\n10:40  \nDie neue Verantwortung der Ethik-Kommissionen\nI. Wessler\, LAEK Mainz\, Wiesbaden \n\n11:10 \nAntrag für das Genehmigungsverfahren\nF. Hackenberger\, BfArM\, Bonn \n\n11:45 \nGCP-Inspektionen nach neuem Recht\nG. Schwarz\, BfArM\, Bonn \n\n12:20  \nIMPD-Unterlagen zur pharmazeutischen Qualität für Phase-IStudien im Vergleich zu späteren Prüfphasen\nS. Keitel\, BfArM\, Bonn \n\n12:55 \nAdverse Events-Meldungen nach dem 1. Mai 2004\nF. Hackenberger\, BfArM\, Bonn \n\n11:00 - 13:30 \nEinführung in die Pharmakokinetik\nW. Cawello\, Schwarz Pharma\, Monheim \n\n11:00 - 13:30  \nEarned Value Analysis (EVA) and Management (EVM)\nW. Seifert\, Schering\, Berlin \n\n13:30 - 14:30 \nStudy Nurse Meeting \n\n14:30 - 15:30 \nStudy Nurse Kurs\nPraktischer Umgang mit den Genehmigungsanträgen gemäß\n12. AMG-Novelle und Rechtsverordnung bei Ethikkommissionen und BOB\nR. Frey\, Bayer AG\, Wuppertal \n\n13:30 - 15:30 \nLunch Break\nKaffeepausen werden während der Veranstaltungen bekannt gegeben \n\n15:45 - 18:00  \n12. AMG Novelle – Diskussionsforum\nI. Klingmann\, Pharmaplex\, Brüssel; H. Fuder\, Parexel\, Berlin \n\n15:45  \nStudienvorbereitung in der Phase I vor und nach dem 01. Mai 2004\nVorsitz: W. See\, Focus\, Neuss\nTeilnehmer: B. Lehmann\, F. Hackenberger\, I. Wessler\, G. Schwarz\, R. Frey\,\nM. Seibert-Grafe\n• Informationszusammenführung beim Sponsor\n• Erstellung des IMPD\n• Konsistenz zwischen EUDRACT\, IB\, IMPD\, Studienanträgen EK und\nBfArM\n• IT-Anforderungen \n\n16:30  \nStudiendurchführung und Studienabschluss\nVorsitz: D. Chase\, Kendle\, München\nTeilnehmer: F. Hackenberger\, G. Mikus\, R. Schulz\, I. Klingmann\, S. Keitel\, H. Fuder\n• Amendments\n• Pharmakovigilanz\n• Meldung des Studienendes\n• Berichterstattung\n• Archivierung \n\n17:15  \nGewährleistung der Effektivität des neuen Systems durch optimale Kommunikation und Kollaboration aller beteiligten Parteien\nVorsitz: I. Klingmann\, Pharmaplex\, Brüssel\nTeilnehmer: B. Lehmann\, H. Fuder\, W. Sittner\, F. Hackenberger\, I. Wessel\, W. See\, M. Seibert-Grafe\, D. Chase\, S. Keitel\, G. Schwarz\n• Sponsor - CRO\n• Sponsor - Prüfer\n• Sponsor – Ethik-Kommission - Prüfer\n• Sponsor – BfArM – Ethik-Kommission \n\n15:30 - 18:00 \nGrundlagen der Biometrie Beschreibende und schließende Statistik in klinischen Studien \nT. Sudhop\, M. Reber\, Abt. f. Klinische Pharmakologie\, Universität Bonn \n\n18:00 - 19:00 \nDelegates Come Together / Standing Dinner (Schering) \n\n19:00 - 21:30 \nAGAH Members Meeting (Schering) \n\n\n\n\n	Day 2\, Monday\, 01.03.2004  \n07:45  \nOpening of Congress Office \n\n08:30 - 09:00  \nWelcome\nThomas Gramatté\, AGAH President\, Wolf Sittner\, Schering Representative\nBarbara Schug\, Christian Reh\, Conference Chairs \n\n09:30 - 09:45 \nDiscussion \n\n09:00 - 09:30 \nChildren: rationale for definitions of subpopulations\nMatthias Schwab\, Margarete-Fischer-Bosch Institute\, Stuttgart \n\n09:45 - 10:15 \nEthnics: relevance of the genotype with special focus on drug metabolising enzymes and transporters\nIngolf Cascorbi\, University of Greifswald \n\n10:15 - 10:30 \nDiscussion \n\n10:15 - 10:45 \nCoffee Break / Poster Presentation \n\n10:45 - 11:30  \nDialysed patients: differences in dialysis methods – technical aspects Frantisek Lopot\, University of Prague\nDialysed patients: differences in dialysis methods – clinical relevance\nSylvie Sulkova\, University of Prague \n\n11:30 - 11:45  \nDiscussion \n\n11:45 - 12:15 \nDiabetics: a patient group with special population characteristics\nRobert Hermann\, Altana\, Konstanz \n\n12:15 - 12:30 \nDiscussion \n\n12:30 - 12:40 \nPresentation of invited session poster and discussion Invited Session Poster:\nMethods for determination of renal impairment – a critical review with special focus on Cockcroft-Gault\nCarsten Meyerhoff\, Health Management Consulting\, Langenau \n\n12:40 - 14:00  \nLunch Break / Industry Exhibition \n\n14:00 - 14:30  \nPhenotypic and genetic heterogeneity in schizophrenia: pharmacogenetic studies\nMarcella Rietschel\, Zentralinstitut für seelische Gesundheit\, Mannheim \n\n14:30 - 14:45  \nDiscussion \n\n14:45 - 15:15 \nEarly drug development in obesity \n\n15:15 - 15:30 \nDiscussion \n\n15:30 - 16:00  \nCoffee Break / Poster Presentation \n\nSession III \n Design development in studies with special populations\nChairs: Ulrike Ebert\, Berno Müller \n\n16:00 - 16:30  \nExtrinsic factors and clinical trials in specific ethnic groups\nAnnette Gross\, GlaxoSmithKline\, Sydney \n\n16:30 - 16:45  \nDiscussion \n\n16:45 - 17:15 \nReduction of inconveniences in studies with children – microtechniques in immunology\nClaudius U. Meyer\, University of Mainz \n\n17:15 - 17:30 \nDiscussion \n\n17:30 - 18:00  \nClinical studies with cytostatics in children\nAlexandra Wagner-Bohn\, University of Münster \n\n19:00 \nBus transfer to Reichstag \n\n19:30  \nConference Banquet (Reichstag)\nPresentation of prizes (posters) \n\n\n\n\n	Day 3\, Tuesday\, 02.03.2004  \nSession IV  \nStudy design and evaluation: Biometric planning and study evaluation\nChairs: Barbara Schug\, Carsten Meyerhoff \n\n08:30 - 09:00  \nSample size and decision criteria: PK/PD modelling as basis for\n∆ definition or when are changes clinically relevant\nWilli Weber\, Aventis\, Frankfurt \n\n09:00 - 09:15  \nDiscussion \n\n09:15 - 09:45  \nInfluence of co-variates on study outcome in the elderly (age\, weight\, renal function and absorption)\nBernd Rosenkranz\, Jerini\, Berlin \n\n09:45 - 10:00  \nDiscussion \n\n10:00 - 10:30  \nCoffee Break / Poster Session \n\n10:30 - 11:00  \nInhibition of ovulation: The intelligent use of surrogate parameters\nIngrid Duijkers\, Dinox\, Nijmegen \n\n11:00 - 11:15 \nDiscussion \n\n11:15 - 11:45  \nCan well-designed phase II/III trials and populations PK evaluation be used as surrogate for studies in special\npopulations and drug-drug interaction studies?\nHans G. Schaefer\, Boehringer Ingelheim\, Biberach adR \n\n11:45 - 12:00  \nDiscussion \n\nSession V  \nThe regulatory situation: Consequences for labelling and\nregistration – a conclusion of the conference – Part A\nChairs: Tomas Salmonson\, Bernd Rosenkranz \n\n12:00 - 12:10 \nPresentation of invited session poster and discussion Invited Session Poster:\nOverview over study designs proposed in international guidelines\nCharlotte Herrlinger\, Carsten Meyerhoff\, Anne-Kathrin Riethling \n\n12:10 - 12:40  \nGuidelines for the investigation of the effects of impaired hepatic function – a critical appraisal\nChristian de Mey\, ACPS\, Mainz \n\n12:40 - 12:55  \nDiscussion \n\n13:00 - 14:30  \nLunch Break / Industry Exhibition \n\n14:30 - 14:50  \nBridging studies for ethnics – a reduction in the number of studies for international approvals\nBeate Rohde\, Wolf Sittner\, Schering\, Berlin\, and Mitsuhiro Mori\, NihonSchering\, Osaka \n\n14:50 - 15:00  \nDiscussion \n\n15:00 - 15:30  \nWhen are studies in special populations necessary?\nTomas Salmonson\, Medicinal Products Agency\, Uppsala \n\n15:30 - 15:45  \nDiscussion \n\n15:45 - 16:00  \nSession’s summary of the conference chairs\nChristian Reh\, Pharmacon\, Berlin\, Barbara Schug\, SocraTec R&D\,\nOberursel \n\n15:45 - 16:00 \nClosing Remarks\nGerd Mikus\, AGAH President \n\n\n\n\n	Presentations of the Annual Meeting 2004 \n\nWorkshop on the German Medicinal Act (AMG) – Supporting Material\n\n\n„Kabinettsentwurf“ 12th amendment to the AMG (15.10.2003\, German)\nKabinettsentwurf-zur-12.-AMG-Novelle-15.10.2003_01 \n\n\nStellungnahme des Bundesrats (14.01.2004\, German)\nStellungnahme-Bundesrat-14.01.2004_01 \n\nGutachterliche Stellungnahme (27.01.2004\, German)\nGutachtliche-Stellungnahme-27.01.2004_01 \n\nWorkshop on the German Medicinal Act (AMG) – Presentations\n\nB. Lehmann\, Bruxelles (EU Com.)\nEuropaeische-Hintergruende-der-Richtlinie-2001-20-EG-Lehmann_01\nEuropean Background of the Directive 2001/20/EC \n\nI. Wessler\, Mainz (IEC ÄK RLP)\n\nF. Hackenberger\, Bonn (BfArM)\nGenehmigungsverfahren-bei-der-BOB-Hackenberger_01\nClinical trial application at the German federal competent authority (German) \n\nG. Schwarz\, Bonn (BfArM)\nGCP-Inspektionen-Schwarz_01\nGCP inspections under new regulation (German) \n\nS. Keitel\, Bonn (BfArM)\nIMPD-CMC-Keitel_01\nThe CMC part of the IMPD: Phase I trials compared to phase II/III trials (German) \n\nF. Hackenberger\, Bonn (BfArM)\nSUSAR-Meldungen-Hackenberger_01\nAdverse Event Reports after May 1\, 2004 (German) \n\nPrkatischer-Umgang_01\nPractical considerations on clinical trial applications according the 12th amendment of the German AMG to be submitted to ethic committee and competent authority (BfArM) [German] \n\nWorkshop Biometry\n\nM. Reber and T. Sudhop\, Bonn\nWorkshop-Grundlagen-Biometrie-Reber-Sudhop_01\nBasis of Biometry – Descriptive and analytical statistics in clinical trials
URL:https://dev.agah.eu/event/13th-agah-annual-meeting-2004/
LOCATION:Annual Meeting 2004\, Berlin\, Deutschland
CATEGORIES:Annual Meetings
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