COVID-19: Risk Based Quality Management & Monitoring Webinar with Gunnar Danielsson

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

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When: Tuesday June 16th
Time: 10:00 to 11:30 CET (Central European Time)
Where: Free Online webinar with Teams

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Register now!

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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

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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.