Audit Essentials - Preparation with practical relevance for investigator sites

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: € 740.00 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)                       
9 am to 1 pm CET

Dates:  
Tuesday & Wednesday, 20. & 21. May 2025       
Further dates will follow.

Please use our registration form to register.

Training content:

• Regulatory framework in Clinical Trials:
  • ICH E6 GCP (R3)
  • EU-CTR 536/2014
  • German Medical Act
• Requirements for sponsors according to ICH E6 GCP 
• Requirements for trial centres according to ICH E6 GCP 
• Definition/ objectives of audits
• Risk management
• Audit preparation
• Hosting an Audit
  • Administrative Topics
  • Opening/ Implementation/ Closing 
  • Handling of Findings & CAPA-measures
• Practical examples: How would you handle this?
• Dealing with interviews in audits: tips for a successful communication

The training can be performed as an inhouse training.

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