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
B. Schug, Oberursel/Germany


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 site

J. Ziegler, Oberursel/Germany



Quality assurance and improvement

R. Darkow, Leverkusen/Germany

12:00 Overall Discussion
12:30 Break

Quality Management at „Clinical Research Center (CRC) Hannover“: Concepts and experiences

in early phase clinical trials

I. 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

16:45 Summarising discussion
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
B. Schug, Oberursel/Germany


Differences between inspections at early phase clinical pharmacology units and inspections at clinical therapy centers – An introduction given by the German Competent Authority 

K. Mettke, Bonn/Germany

Inspection safe chain of custody – a complex interplay of quality management system, qualification, study protocol, source data sheets and CRF

B. 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


Overall Discussion

15:15 Break

Inspection experience and interpretation of guidance on e-CRF and e-TMF

H. Gertzen, Paris/France
16:15 Summarising discussion
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

(DGPharMed, DGKliPha)

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
53175 Bonn/Germany

Contact and further information

Association for Applied Human Pharmacology (AGAH) e.V. 
office: Goernestraße 30
20249 Hamburg

phone: +49 170 7844438
E-Mail: info ( a t )


CSi Hamburg GmbH
Conferences | Symposia | Incentives
Goernestraße 30
20249 Hamburg

phone: +49 40 30770300
fax:       +49 40 30770301
e-Mail:  agah-veranstaltungen ( a t )

May we please ask you to use the registration form.