-P O S T P O N E D-
The health and wellbeing of our employees, our clients, and the society, in general, is of utmost importance to us and therefore, our Risk Based Quality Management & Monitoring seminar with Gunnar Danielsson and Philip Lange Møller will be postponed due to the coronavirus.
We will continue to monitor the situation and will send out information as soon as we can start planning another live event.
Thank you for your interest!
Date: Will be posted at a later date
Place: LINK Medical Copenhagen office:
Vimmelskaftet 47. 1. Sal
DK-1161 København K, Denmark
Time: 14:00 – 16:30 +Mingle
RBM 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. The responsibility for these processes always lies with the sponsor, irrespectively if the task in itself is delegated to an outside vendor.
Come listen to Gunnar Danielsson senior regulatory advisor, and Philip Lange Møller from Denmark, two former GCP Inspectors, talk about this subject. At this seminar you will learn:
The purpose & regulations for RBQM & Monitoring.
- How to change the mindset for the implementation of updated processes.
- What authorities expect in regards to RBM.
- Practical implementation of Risk-Based Monitoring.
13:30 – Registration opens
14:00 – Start, welcome intro by host
14:05 – Risk Quality Management (Gunnar & Phillip)
14:55 – Coffee break
15:15 – Risk-Based Monitoring
15:45 – Practical examples
16:05 – Q/A
16:35 – Mingle
17:30 – ends
About the Speakers:
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.
Philip Lange Møller has been a Medicines Inspector at the Danish Medicines Agency until July 2018 inspecting clinical trials on medicines and medical devices. He has worked at the Danish Medicines Agency since 2006 first on national inspections and since 2007 also inspecting clinical trials requested by EMA (CHMP) in Europe and the rest of the world. He has been a member of the EMA GCP Inspectors Working Group and he was involved in several guideline-drafting groups for EMA and Commission guidelines.
Prior to joining the Danish Medicines Agency, Philip has led a clinical research team and been principal investigator – coordinating investigator – investigator-sponsor for clinical trials as well as medical advisor and clinical project leader in pharmaceutical companies.
Philip is a graduated physician of 1988 from Aarhus University in Denmark and trained in internal medicine and anesthesia until 1997.