Sponsor Oversight / Vendor Oversight in Clinical Trials
This course provides an overview of the basics of sponsor / vendor oversight, such as the creation of an SOP and an oversight plan, the functions to be monitored and the corresponding documentation. Special attention is also paid to practical cooperation with the vendors. In addition, the group can discuss their own challenges and possible solutions.
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 Trial Associates, Clinical Project Managers, Quality Assurance Managers, Auditors, Medical Writer, Data Manager, Statisticians
Participation fee: € 840.00 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 - 16.00 hrs
Date:
Thursday, 30 January 2023
Please use our registration form to register.
Registration deadline: 16.01.2025
Training content:
- Different regulations
- Development of processes
- Preparation of a Sponsor Oversight SOP
- Preparation of a Sponsor Oversight plan
- Recommended activities
- Selection of the right vendor
- Oversight on Site Management Activities
- Oversight on TMF
- Setting up KPIs
- Documentation of Sponsor Oversight Activities
- Establishing effective communication / governance processes
The training can also be offered as in-house training.
Anmeldung zum Kurs "Sponsor Oversight / Vendor Oversight in Clinical Trials":
Rossertblick 18
65527 Niedernhausen