When: Oct. 01 2019
Where: Danish LINK Medical office
Vimmelskaftet 47. 1. Sal
DK-1161 København K
Time: 12:30 – 16:00 (includes a small lunch)
Regardless of the size of your company or the phase you are in, it is important to be prepared for an inspection from the authorities.
Join us Oct. 1 in Copenhagen where we have gathered two former GCP Inspectors, Philip Lange Møller from Denmark and Gunnar Danielsson from Sweden, together under one roof to share their knowledge and experiences. In this seminar, you will learn key things to expect when the GCP inspector is inevitably at the door.
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 anaesthesia until 1997.
12:30 Registration/small snack lunch
13:15 Lecture start part I with Gunnar & Philip
14:30 Break /coffee (15 min break)
14:45 Part II with Gunnar & Philip
16:00 Questions / Answers
In this lecture you will learn about the following subjects:
- How do you prepare for the inspection?
- What happens during the inspection?
- How should you follow-up the inspection?