2018

27.10.2018,  Hannover
Speaker: Dr. Christoph Ortland
Subject: GCP update training course:  ICH-GCP E6 (R2) (EMA/CHMP/ICH/135/1995) and  EU Clinical Trials Regulation (536/2014)

2016

09.09./10.09.2016, Munich
Speaker: Dr. Dagmar Chase
Subject: GCP –Refresher: EU Clinical Trials Regulation (536/2014), amendment to German Drug Law (4. AMG Änderungsgesetz zur Klinischen Prüfung), ICH-GCP Addendum, Inspection findings

2015

19.06./20.06.2015, Stuttgart
Speaker: Margret Klose
Subject: GCP -Audit in Clinical Research (how to become an Auditor)

2014

10.05.2014, Hannover
Speakers: Dr. Thomas Lanz, Annette Köhler
Subject: Risk Based Monitoring – new roles for experienced CRAs (seminar and workshop)

09.05.2014, Hannover
Speakers: Dr. Melanie Eckert (Project Manager Clinical Trials, Winicker Norimed GmbH, Nürnberg)
Subject: Non Investigational Studies (NIS)

2013

19.04./20.04.2013, Hannover
Speaker: Dr. Christoph Ortland (das forschungsdock®)
Subject: Clinical trials – Current requirements concerning submission to German ethics committees and German authorities

2012

28. und 29. Oktober 2011 Hannover
Trainer: Susanne Gebhardt, Management Consultant www.maxxresult.de
Subject: Self-presentation and negotiation skills

2011

27.04.2012 München
Speaker: Dr. Dagmar Chase (Clinrex GmbH)
Subject: GCP Refresher: Update in regulatory aspects
and inspection findings

2010

30.10.2010 Lüneburg
Trainer: Prof. H. Brasch, AstraZeneca GmbH, Wedel
Subject: Drug Safety, collection and evaluation of adverse events in clinical trials

19.06.2010 Bad Homburg
Trainer: Dr. Thilo Räpple (lawer), Baker & McKenzie
Subject: Form of Contract between Sponsor and Freelance CRAs

Trainer: Alexander Wagner (tax consultant)
Subject: Tax Law for Freelance CRAs

2009

31.10.2009 Stuttgart
Trainer: Margret Klose
The monitor between the demands of GCP-regulatories, QA-departments, Audits and Inspections – sharing of experiences

30.10.2009 Stuttgart
Trainer: Dr. Lisa Tomaschek-Habrina and Erich Platzer
Subject: Burnout and stress management

2008

15.11.2008 Hannover
Trainer: Dr. med. Martin Hulpke-Wette
Subject: Clinical trials with children

31.05.2008 Bensheim-Auerbach
Trainer: Dr. T. Räpple (lawer)
Subject: Form of contract between freelance CRA and sponsor

Trainer: Heiko Jörß (lawer)
Subject: Tax law for freelance CRAs

2007

20.10.2007 Potsdam
Trainer: Dr. Heike Vonhausen (Clinical Research Abbott Vascular)
Subject: Clinical research with medical devices (German law for medical devices/ ISO 14155)

2006

02.12.2006 Uetersen
Trainer: Mathias Schubert
(Clinical Process Manager, AstraZeneca GmbH)
Subject: Results of audits and Inspections of study sites.

Trainer: Annette Köhler (Freelance CRA)
Subject: Quality assurance in clinical trials:
Accompanied site visit

14.01.2006 Duisburg
Trainer: Dr. Christoph Ortland
(Project Manager, photonamic GmbH&Co.KG)
Subject: Current update of German Medicines Law (12. Novellierung des Arzneimittelgesetzes)

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