
13th AGAH Annual Meeting 2004
Annual Meeting 2004, Berlin
Special Populations: what makes them so special? Current issues in study design, evaluation and regulatory affairs during drug development
February 29 – March 2, 2004, Schering AG, Berlin
The 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.
Additional workshops dealt with actual topics such as the upcoming implementation of the European trial directive into German law.
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
10:00 - 13:30
12. AMG Novelle – aktueller Stand Phase-I-Studien im neuen regulatorischen Umfeld
I. Klingmann, Pharmaplex, Brüssel; H. Fuder, Parexel, Berlin
10:00
Willkommen und Einleitung
I. Klingmann, Brüssel
10:10
Europäische Hintergründe der Richtlinie 2001/20/EG
B. Lehmann, European Commission, Brüssel
10:40
Die neue Verantwortung der Ethik-Kommissionen
I. Wessler, LAEK Mainz, Wiesbaden
11:10
Antrag für das Genehmigungsverfahren
F. Hackenberger, BfArM, Bonn
11:45
GCP-Inspektionen nach neuem Recht
G. Schwarz, BfArM, Bonn
12:20
IMPD-Unterlagen zur pharmazeutischen Qualität für Phase-IStudien im Vergleich zu späteren Prüfphasen
S. Keitel, BfArM, Bonn
12:55
Adverse Events-Meldungen nach dem 1. Mai 2004
F. Hackenberger, BfArM, Bonn
11:00 - 13:30
Einführung in die Pharmakokinetik
W. Cawello, Schwarz Pharma, Monheim
11:00 - 13:30
Earned Value Analysis (EVA) and Management (EVM)
W. Seifert, Schering, Berlin
13:30 - 14:30
Study Nurse Meeting
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
13:30 - 15:30
Lunch Break
Kaffeepausen werden während der Veranstaltungen bekannt gegeben
15:45 - 18:00
12. AMG Novelle – Diskussionsforum
I. Klingmann, Pharmaplex, Brüssel; H. Fuder, Parexel, Berlin
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
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
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
15:30 - 18:00
Grundlagen der Biometrie Beschreibende und schließende Statistik in klinischen Studien
T. Sudhop, M. Reber, Abt. f. Klinische Pharmakologie, Universität Bonn
18:00 - 19:00
Delegates Come Together / Standing Dinner (Schering)
19:00 - 21:30
AGAH Members Meeting (Schering)
07:45
Opening of Congress Office
08:30 - 09:00
Welcome
Thomas Gramatté, AGAH President, Wolf Sittner, Schering Representative
Barbara Schug, Christian Reh, Conference Chairs
09:30 - 09:45
Discussion
09:00 - 09:30
Children: rationale for definitions of subpopulations
Matthias Schwab, Margarete-Fischer-Bosch Institute, Stuttgart
09:45 - 10:15
Ethnics: relevance of the genotype with special focus on drug metabolising enzymes and transporters
Ingolf Cascorbi, University of Greifswald
10:15 - 10:30
Discussion
10:15 - 10:45
Coffee Break / Poster Presentation
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
11:30 - 11:45
Discussion
11:45 - 12:15
Diabetics: a patient group with special population characteristics
Robert Hermann, Altana, Konstanz
12:15 - 12:30
Discussion
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
12:40 - 14:00
Lunch Break / Industry Exhibition
14:00 - 14:30
Phenotypic and genetic heterogeneity in schizophrenia: pharmacogenetic studies
Marcella Rietschel, Zentralinstitut für seelische Gesundheit, Mannheim
14:30 - 14:45
Discussion
14:45 - 15:15
Early drug development in obesity
15:15 - 15:30
Discussion
15:30 - 16:00
Coffee Break / Poster Presentation
Session III
Design development in studies with special populations
Chairs: Ulrike Ebert, Berno Müller
16:00 - 16:30
Extrinsic factors and clinical trials in specific ethnic groups
Annette Gross, GlaxoSmithKline, Sydney
16:30 - 16:45
Discussion
16:45 - 17:15
Reduction of inconveniences in studies with children – microtechniques in immunology
Claudius U. Meyer, University of Mainz
17:15 - 17:30
Discussion
17:30 - 18:00
Clinical studies with cytostatics in children
Alexandra Wagner-Bohn, University of Münster
19:00
Bus transfer to Reichstag
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
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
09:00 - 09:15
Discussion
09:15 - 09:45
Influence of co-variates on study outcome in the elderly (age, weight, renal function and absorption)
Bernd Rosenkranz, Jerini, Berlin
09:45 - 10:00
Discussion
10:00 - 10:30
Coffee Break / Poster Session
10:30 - 11:00
Inhibition of ovulation: The intelligent use of surrogate parameters
Ingrid Duijkers, Dinox, Nijmegen
11:00 - 11:15
Discussion
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
11:45 - 12:00
Discussion
Session V
The regulatory situation: Consequences for labelling and
registration – a conclusion of the conference – Part A
Chairs: Tomas Salmonson, Bernd Rosenkranz
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
12:10 - 12:40
Guidelines for the investigation of the effects of impaired hepatic function – a critical appraisal
Christian de Mey, ACPS, Mainz
12:40 - 12:55
Discussion
13:00 - 14:30
Lunch Break / Industry Exhibition
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
14:50 - 15:00
Discussion
15:00 - 15:30
When are studies in special populations necessary?
Tomas Salmonson, Medicinal Products Agency, Uppsala
15:30 - 15:45
Discussion
15:45 - 16:00
Session’s summary of the conference chairs
Christian Reh, Pharmacon, Berlin, Barbara Schug, SocraTec R&D,
Oberursel
15:45 - 16:00
Closing Remarks
Gerd Mikus, AGAH President
Workshop on the German Medicinal Act (AMG) – Supporting Material
„Kabinettsentwurf“ 12th amendment to the AMG (15.10.2003, German)
Stellungnahme des Bundesrats (14.01.2004, German)
Stellungnahme-Bundesrat-14.01.2004_01
Gutachterliche Stellungnahme (27.01.2004, German)
Gutachtliche-Stellungnahme-27.01.2004_01
Workshop on the German Medicinal Act (AMG) – Presentations
B. Lehmann, Bruxelles (EU Com.)
Europaeische-Hintergruende-der-Richtlinie-2001-20-EG-Lehmann_01
European Background of the Directive 2001/20/EC
I. Wessler, Mainz (IEC ÄK RLP)
F. Hackenberger, Bonn (BfArM)
Genehmigungsverfahren-bei-der-BOB-Hackenberger_01
Clinical trial application at the German federal competent authority (German)
G. Schwarz, Bonn (BfArM)
GCP-Inspektionen-Schwarz_01
GCP inspections under new regulation (German)
S. Keitel, Bonn (BfArM)
IMPD-CMC-Keitel_01
The CMC part of the IMPD: Phase I trials compared to phase II/III trials (German)
F. Hackenberger, Bonn (BfArM)
SUSAR-Meldungen-Hackenberger_01
Adverse Event Reports after May 1, 2004 (German)
Prkatischer-Umgang_01
Practical considerations on clinical trial applications according the 12th amendment of the German AMG to be submitted to ethic committee and competent authority (BfArM) [German]
Workshop Biometry
M. Reber and T. Sudhop, Bonn
Workshop-Grundlagen-Biometrie-Reber-Sudhop_01
Basis of Biometry – Descriptive and analytical statistics in clinical trials
29. Februar 2004 - 2. März 2004
13th AGAH Annual Meeting 2004
Annual Meeting 2004
Berlin
Deutschland