AGAH-Workshop Quality Management in Early Phase Clinical Units
03 – 04 November 2016 in Bonn
Early phase trials are different!
Although classified as clinical trials in healthy subjects or patients that are principally conducted under GCP-standards, due to the experimental setting also GLP aspects need to be considered for this kind of trials. Their quality management requirements are a challenging demand for investigators and study nurses but also for sponsors and auditors as well as inspectors, not least because of the responsibility for subjects’ safety. This often applies not only to first-in-human-, bioequivalence and PK-studies but also to Phase-II-proof-of-concept trials.
Join our 2-days-workshop on “Quality Management in Early Phase Clinical Pharmacology Units” to learn about the principles of quality management systems to be established by CROs and university research institutions. These QMS principles are illuminated from the perspectives of experienced QM-managers from CPUs, sponsors and by inspectors from the European Union.
Consequently, our workshop addresses professionals working in the field of clinical trials at sponsor-CPUs, CROs and university hospitals as well as sponsors selecting CPUs and representatives of authorities.
The first day shall serve as training workshop to improve your knowledge about quality management systems including quality assurance activities, training, standardisation of processes as well as error management and continuous improvement procedures in early clinical trials. Furthermore, site selection criteria to ensure data quality and integrity as well as subjects’ safety and vendor management in consideration of early phase trial characteristics will be discussed.
The second day shall focus on findings from audit and inspection activities to improve awareness for the necessity of a thoughtful Quality Management System. And – very important – the knowledge about difficulties and findings is very helpful to develop solutions and implement adequate Quality Management Systems at sponsor’s and CPU´s site that could help to prevent not only errors and fatal mistakes but also systematic misconduct and even fraud.
Day 1: Thursday, 03 November 2016
Day 1: Managing quality in early phase clinical trials
Welcome and Introduction
Elements affecting quality in early phase clinical trials
H. Angele and B. Schieder, Ingelheim/Germany
Quality management systems in early phase clinical pharmacology units and differences between QMS
at sponsor´s, CRO´s and investigator´s siteJ. Ziegler, Oberursel/Germany
Quality assurance and improvement
R. Darkow, Leverkusen/Germany
Quality Management at „Clinical Research Center (CRC) Hannover“: Concepts and experiences
in early phase clinical trialsI. Fleischhauer, Hannover/Germany
Qualification of CPUs in the view of the Ethics Committee
P. Knupfer, Esslingen/Germany
Relevance of G(C)LP and validation procedures in the clinical setting of early phase trials
in healthy subjects and patients
B. Schug, Oberursel/Germany
Sponsor responsibility site selection – peculiarities of early phase clinical trials
S. Dürr, Starnberg/Germany
|17:00||End of workshop|
Day 2: Friday, 04 November 2016
Day 2: Quality aspects during audits and inspections in early phase clinical trials
Welcome and Introduction
Differences between inspections at early phase clinical pharmacology units and inspections at clinical therapy centers – An introduction given by the German Competent AuthorityK. Mettke, Bonn/Germany
Inspection safe chain of custody – a complex interplay of quality management system, qualification, study protocol, source data sheets and CRFB. Schug, Oberursel/Germany
Inspection findings in early phase clinical trials – an introduction into the discussion
K. Mettke, Bonn/Germany
Round table discussion with representatives of the German and European Competent Authorities
D. Delforge, Brussels/Belgium; all participants
How to prepare a CPU for an inspection?
K. Baas, It Heidenskip/The Netherlands
Inspection experience and interpretation of guidance on e-CRF and e-TMFH. Gertzen, Paris/France
|16:30||End of workshop|
Attendance Fees for 1 day or (2 days)
|340 € (680 €)|
|240 € (480 €)||Members of the AGAH |
or one of the VKliPha-Societies
or Junior Scientist up to the age of 30 years
The participation fee is per person. Please note,according to §4 para 22 German turnover tax law, registration and workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.V. All bookings are subject to change
CME certification (continuing medical education credit points) of the Medical Association Nordrhein has been requested.
GSI Gustav-Stresemann-Institut e.V.
Langer Grabenweg 68
Contact and further information
Association for Applied Human Pharmacology (AGAH) e.V.
office: Goernestraße 30
CSi Hamburg GmbH
Conferences | Symposia | Incentives
phone: +49 40 30770300
fax: +49 40 30770301
e-Mail: agah-veranstaltungen ( a t ) csihamburg.de
May we please ask you to use the registration form.