13th AGAH Annual Meeting 2004

Date:
29.02.-02.03.2004

Conference venue:
Berlin, Schering AG

Programme Committee:
• Kerstin Breithaupt-Grögler, Frankfurt
• Ulrike Ebert, Universität Heidelberg
• Charlotte Herrlinger, 4SC, Martinsried
• Carsten Meyerhoff, Health Management Consulting, Langenau
• Berno Müller, Pharmacon, Berlin
• Anne-Kathrin Riethling, Universität Rostock
• Bernd Rosenkranz, Jerini, Berlin
• Tomas Salmonson, Medicinal Products Agency, Uppsala
• Meinolf Wonnemann, SocraTec R&D, Oberursel
• Michael Zühlsdorf, Bayer, Wuppertal

Organisational Committee:
• Wolf Sittner, Schering, Berlin
• Amira Skapur, SocraTec R&D, Oberursel
• Yvonne Spiegel, Schering, Berlin
• Thomas Staks, Schering, Berlin
• Marianne Weiß, Schering, Berlin

 

• Costs:
  400 Euro after January 1, 2004
  25 Euro reduction for AGAH-, ACCP-, and Club-Phase-I-Members
  100 Euro participation on Sunday only
  250 Euro for junior scientists below 30 years of age (limited numbers only)
  150 Euro for junior poster presenters below 30 years of age

 

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10:00 - 13:30

12. AMG Novelle – aktueller Stand Phase-I-Studien im neuen regulatorischen Umfeld
I. Klingmann, Pharmaplex, Brüssel; H. Fuder, Parexel, Berlin

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10:00

Willkommen und Einleitung
I. Klingmann, Brüssel

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10:10

Europäische Hintergründe der Richtlinie 2001/20/EG
B. Lehmann, European Commission, Brüssel

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10:40

Die neue Verantwortung der Ethik-Kommissionen
I. Wessler, LAEK Mainz, Wiesbaden

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11:10

Antrag für das Genehmigungsverfahren
F. Hackenberger, BfArM, Bonn

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11:45

GCP-Inspektionen nach neuem Recht
G. Schwarz, BfArM, Bonn

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12:20

IMPD-Unterlagen zur pharmazeutischen Qualität für Phase-IStudien im Vergleich zu späteren Prüfphasen
S. Keitel, BfArM, Bonn

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12:55

Adverse Events-Meldungen nach dem 1. Mai 2004
F. Hackenberger, BfArM, Bonn

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11:00 - 13:30

Einführung in die Pharmakokinetik
W. Cawello, Schwarz Pharma, Monheim

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11:00 - 13:30

Earned Value Analysis (EVA) and Management (EVM)
W. Seifert, Schering, Berlin

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13:30 - 14:30

Study Nurse Meeting

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14:30 - 15:30

Study Nurse Kurs
Praktischer Umgang mit den Genehmigungsanträgen gemäß
12. AMG-Novelle und Rechtsverordnung bei Ethikkommissionen und BOB
R. Frey, Bayer AG, Wuppertal

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13:30 - 15:30

Lunch Break
Kaffeepausen werden während der Veranstaltungen bekannt gegeben

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15:45 - 18:00

12. AMG Novelle – Diskussionsforum
I. Klingmann, Pharmaplex, Brüssel; H. Fuder, Parexel, Berlin

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15:45

Studienvorbereitung in der Phase I vor und nach dem 01. Mai 2004
Vorsitz: W. See, Focus, Neuss
Teilnehmer: B. Lehmann, F. Hackenberger, I. Wessler, G. Schwarz, R. Frey,
M. Seibert-Grafe
• Informationszusammenführung beim Sponsor
• Erstellung des IMPD
• Konsistenz zwischen EUDRACT, IB, IMPD, Studienanträgen EK und
BfArM
• IT-Anforderungen

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16:30

Studiendurchführung und Studienabschluss
Vorsitz: D. Chase, Kendle, München
Teilnehmer: F. Hackenberger, G. Mikus, R. Schulz, I. Klingmann, S. Keitel, H. Fuder
• Amendments
• Pharmakovigilanz
• Meldung des Studienendes
• Berichterstattung
• Archivierung

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17:15

Gewährleistung der Effektivität des neuen Systems durch optimale Kommunikation und Kollaboration aller beteiligten Parteien
Vorsitz: I. Klingmann, Pharmaplex, Brüssel
Teilnehmer: B. Lehmann, H. Fuder, W. Sittner, F. Hackenberger, I. Wessel, W. See, M. Seibert-Grafe, D. Chase, S. Keitel, G. Schwarz
• Sponsor - CRO
• Sponsor - Prüfer
• Sponsor – Ethik-Kommission - Prüfer
• Sponsor – BfArM – Ethik-Kommission

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15:30 - 18:00

Grundlagen der Biometrie Beschreibende und schließende Statistik in klinischen Studien

T. Sudhop, M. Reber, Abt. f. Klinische Pharmakologie, Universität Bonn

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18:00 - 19:00

Delegates Come Together / Standing Dinner (Schering)

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19:00 - 21:30

AGAH Members Meeting (Schering)

07:45

Opening of Congress Office

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08:30 - 09:00

Welcome
Thomas Gramatté, AGAH President, Wolf Sittner, Schering Representative
Barbara Schug, Christian Reh, Conference Chairs

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09:30 - 09:45

Discussion

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09:00 - 09:30

Children: rationale for definitions of subpopulations
Matthias Schwab, Margarete-Fischer-Bosch Institute, Stuttgart

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09:45 - 10:15

Ethnics: relevance of the genotype with special focus on drug metabolising enzymes and transporters
Ingolf Cascorbi, University of Greifswald

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10:15 - 10:30

Discussion

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10:15 - 10:45

Coffee Break / Poster Presentation

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10:45 - 11:30

Dialysed patients: differences in dialysis methods – technical aspects Frantisek Lopot, University of Prague
Dialysed patients: differences in dialysis methods – clinical relevance
Sylvie Sulkova, University of Prague

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11:30 - 11:45

Discussion

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11:45 - 12:15

Diabetics: a patient group with special population characteristics
Robert Hermann, Altana, Konstanz

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12:15 - 12:30

Discussion

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12:30 - 12:40

Presentation of invited session poster and discussion Invited Session Poster:
Methods for determination of renal impairment – a critical review with special focus on Cockcroft-Gault
Carsten Meyerhoff, Health Management Consulting, Langenau

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12:40 - 14:00

Lunch Break / Industry Exhibition

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14:00 - 14:30

Phenotypic and genetic heterogeneity in schizophrenia: pharmacogenetic studies
Marcella Rietschel, Zentralinstitut für seelische Gesundheit, Mannheim

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14:30 - 14:45

Discussion

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14:45 - 15:15

Early drug development in obesity

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15:15 - 15:30

Discussion

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15:30 - 16:00

Coffee Break / Poster Presentation

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Session III

Design development in studies with special populations
Chairs: Ulrike Ebert, Berno Müller

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16:00 - 16:30

Extrinsic factors and clinical trials in specific ethnic groups
Annette Gross, GlaxoSmithKline, Sydney

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16:30 - 16:45

Discussion

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16:45 - 17:15

Reduction of inconveniences in studies with children – microtechniques in immunology
Claudius U. Meyer, University of Mainz

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17:15 - 17:30

Discussion

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17:30 - 18:00

Clinical studies with cytostatics in children
Alexandra Wagner-Bohn, University of Münster

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19:00

Bus transfer to Reichstag

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19:30

Conference Banquet (Reichstag)
Presentation of prizes (posters)

Session IV

Study design and evaluation: Biometric planning and study evaluation
Chairs: Barbara Schug, Carsten Meyerhoff

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08:30 - 09:00

Sample size and decision criteria: PK/PD modelling as basis for
∆ definition or when are changes clinically relevant
Willi Weber, Aventis, Frankfurt

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09:00 - 09:15

Discussion

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09:15 - 09:45

Influence of co-variates on study outcome in the elderly (age, weight, renal function and absorption)
Bernd Rosenkranz, Jerini, Berlin

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09:45 - 10:00

Discussion

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10:00 - 10:30

Coffee Break / Poster Session

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10:30 - 11:00

Inhibition of ovulation: The intelligent use of surrogate parameters
Ingrid Duijkers, Dinox, Nijmegen

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11:00 - 11:15

Discussion

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11:15 - 11:45

Can well-designed phase II/III trials and populations PK evaluation be used as surrogate for studies in special
populations and drug-drug interaction studies?
Hans G. Schaefer, Boehringer Ingelheim, Biberach adR

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11:45 - 12:00

Discussion

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Session V

The regulatory situation: Consequences for labelling and
registration – a conclusion of the conference – Part A
Chairs: Tomas Salmonson, Bernd Rosenkranz

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12:00 - 12:10

Presentation of invited session poster and discussion Invited Session Poster:
Overview over study designs proposed in international guidelines
Charlotte Herrlinger, Carsten Meyerhoff, Anne-Kathrin Riethling

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12:10 - 12:40

Guidelines for the investigation of the effects of impaired hepatic function – a critical appraisal
Christian de Mey, ACPS, Mainz

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12:40 - 12:55

Discussion

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13:00 - 14:30

Lunch Break / Industry Exhibition

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14:30 - 14:50

Bridging studies for ethnics – a reduction in the number of studies for international approvals
Beate Rohde, Wolf Sittner, Schering, Berlin, and Mitsuhiro Mori, NihonSchering, Osaka

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14:50 - 15:00

Discussion

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15:00 - 15:30

When are studies in special populations necessary?
Tomas Salmonson, Medicinal Products Agency, Uppsala

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15:30 - 15:45

Discussion

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15:45 - 16:00

Session’s summary of the conference chairs
Christian Reh, Pharmacon, Berlin, Barbara Schug, SocraTec R&D,
Oberursel

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15:45 - 16:00

Closing Remarks
Gerd Mikus, AGAH President