Free webinar: Risk Based Quality Management & Monitoring
June 4 @ 10:00 - 11:45
When: Thursday, June 4th, 10.00-11.45
Where: Sign up here. All participants will receive a link to access the webinar.
Risk-Based Quality Management (RBQM) is a regulatory requirement when performing clinical trials. This requirement is an enhanced concept and requires a change in the mindset for the implementation of updated and new processes when conducting clinical studies.
When it comes to the current COVID-19 situation, RBQM will be a good concept to master as it calls for less onsite work and more centralized efforts. Its intention is to work smarter but the responsibility for these processes always lies with the sponsor, irrespectively if the task in itself is delegated to an outside vendor.
Join our webinar and meet Gunnar Danielsson, senior regulatory advisor and former GCP Inspector talk about this subject. At this seminar you will learn:
- Practical implementation of Risk-Based Monitoring and how RBQM can support clinical trials during a pandemic situation
- How to change the mindset for the implementation of updated processes
- Understand what authorities expect in regards to RBM
10.00 – 10.05: Welcome (Hanne Mette Dyrlie Kristen, CEO, The Life Science Cluster)
10.00 – 10.45: Risk Based Quality Management
10.45 – 11.00: Break (questions)
11.00- 11.30: Risk Based Monitoring
11.30 – 11.45: Questions
Gunnar Danielsson, former GCP inspector has traveled around the world performing GCP inspections for the Swedish Medical Product Agency for over 10 years. He has 40 years’ experience in Clinical Research and has a wealth of experience from the Pharmaceutical industry in terms of quality management, electronic systems, data management, and clinical design and conduct. Gunnar today is a key advisory resource and helps to design studies in the most effective way, meeting regulatory requirements.