When it comes to the current COVID-19 situation, RBQM is a critical concept to master as it involves more remote work and centralized efforts, which will be essential to clinical trials moving forward. 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. The responsibility for these processes always lies with the sponsor, irrespective if the task itself is delegated to an outside vendor. Therefore, we encourage all of our current and prospective partner sponsors to attend this timely seminar.
Join our webinar and meet Gunnar Danielsson, Senior regulatory adviser at LINK Medical, 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 RBQM
When: Tuesday June 16th
Time: 10:00 to 11:30 CET (Central European Time)
Where: Free Online webinar with Teams
REGISTRATION IS CLOSED NOW
Agenda:
09:45 – Join online and get accepted to the webinar
10:00 – Start, welcome intro by host
10:05 – Risk Based Quality Management
10:45 – Break
10:55 – Risk-Based Monitoring
11:15 – Q&A
11:30 – End
About the Speaker
Gunnar Danielsson, Senior Regulatory Advisor at LINK Medical and 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.
Special webinar info
The webinar is for people in the biotech & MedTech industry. We reserve the right to decline your registration if you are a competitor or a service provider. We have a limit of 5 students who may join this webinar.
To join the webinar, you must register. After sending your information, you will get a confirmation email. To join the meeting you will receive an email on the day of the event with the join in link. Please note that you may not forward this link.
The webinar will be conducted using Microsoft Teams. If you don’t use Microsoft, you can download the app for free when you click on the link in the email or you can join the online version with no download necessary. The best browser to join the online meeting is the latest version of Chrome.
Please make sure to log in at least 5 minutes before the meeting starts to make sure all technical issues are resolved. If you have any questions please don’t hesitate to contact us with time before the event. It may be difficult to help when the event is starting.
We look forward to seeing you all online!
Best regards,
Claudia Wennberg
Marketing and Brand Manager
claudia.wennberg@linkmedical.eu
+46 708 244 398
It’s not just a question of biology, the strategy is equally important