Risk Based Quality Management in Clinical Trials

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 clinical trial site and vendor audits as a quality specialist and auditor.

Targeted Audience: Clinical Research Associates, Clinical Trial Associates, Clinical Project Managers, Quality Assurance Managers, Auditors, Regulatory Affairs Managers, Qualified Persons

Participation fee: € 790.00 plus VAT.
You will receive the training documents as a pdf file. You will receive a certificate of participation after successful completion of the course.

Duration: Online training (MS Teams)               
09.00 am to 1 pm CET

Date:  
Tuesday & Wednesday, 05 & 06-August-2025

Please use our registration form to register.
Registration deadline: 29-July-2025

Training content:

• Understanding the principles of risk management
• The essentials of a risk management program including the legal background (EU, UK, USA)
• Understanding of ICH Q9(R1) guideline on Quality Risk Management
• Risk communication and reporting
• The importance of stakeholder identification and leadership commitment
• Practical tips, tools, resources and guidance for risk management

The training can also be performed as in-house training.

Anmeldung zum Kurs "Risk Based Quality Management in Clinical Trials":