GCP-Auditor/in zur Durchführung von Audits an Klinischen Prüfzentren

Your speaker: Dr rer. nat. Karin Köhler-Hansner

Trained as a biologist with a doctorate in tumour research, she began her career in clinical research as a freelance CRA. Soon after, she joined one of the major global pharmaceutical companies as a Clinical Study Manager in various indications and with a passion for quality and training. Karin Köhler-Hansner successfully supported and prepared study centres and sponsors for audits and inspections and gained extensive European and global experience by conducting sponsor oversight activities in the indications Rare Diseases and Oncology. After founding her own company, AH Clinical Trials Services GmbH, in 2019, Karin Köhler-Hansner conducts training on clinical research topics and advises on processes related to sponsor oversight, risk management and clinical trial management. She also conducts centre and vendor audits as a quality specialist and auditor

Target group: Prospective GCP auditors from the pharmaceutical research industry.

Participation fee: € 790.00 plus VAT.
In addition to the training documents (PDF), you will receive a certificate of participation after successful completion of the learning success check.

Duration: Virtual classroom training (MS Teams)                       
09.00 - 16.00 hrs each 

Dates:  
Wednesday, 05 June 2024       
Further dates will follow.

Please use our registration form to register.
Registrations are also possible at short notice.

Training content:

• Regulatory framework conditions in clinical trials:
• ICH E6 GCP (R2)
• EU Regulation 536/2014
• Medicinal Products Act
• Requirements for sponsors according to ICH E6 GCP 5.0
• Requirements for trial centres according to ICH E6 GCP 4.0
• Definition/ objectives of audits
• Risk management
• Sponsor Oversight/ Audit Plan
• Implementation of an audit
• Planning and preparation
• Implementation/ final discussion
• Audit report
• CAPA measures
• Catalogue of criteria: Categorise defects correctly/ common "findings"
• Practical examples: how would you decide?
• Dealing with "difficult" test centres/auditees: tips for professional communication
   

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