Unique insight from two senior advisors experienced as GCP inspectors
When: May 24
Time: 14:00 – 17:00
Where: Vimmelskaftet 47. 1. Sal
DK-1161 København K, Denmark
Join us on May 24th in Copenhagen at our free summer mingle event and attend a lecture with two senior advisors experienced as Good Clinical Practice (GCP) inspectors. Philip Lange Møller from Denmark and Gunnar Danielsson from Sweden have over 70 years of combined experience and they will share their most valuable recommendations and key questions to expect when the GCP inspector is inevitably at the door.
Regardless of the size of your company or the clinical phase you are in, being prepared for an inspection from the authorities is imperative. The painful loss of time and money feels the worst when it can be avoided.
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 on an inspection
Agenda:
14:00 Registration opens
14:15 Gunnar and Philip part 1 (45 minutes)
15:00 break 15 minutes
15:15 Gunnar and Philip part 2 (30 minutes)
15:45 Q&A (15 Minutes)
16:00 Mingle with wine and Hors d’oeuvres
17:00 End
Speakers:
Gunnar Danielsson,
Senior Regulatory Advisor
Gunnar Danielsson[@]linkmedical.eu
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 of experience in Clinical Research and a wealth of experience in 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 design studies most effectively, meeting regulatory requirements.
Dr. Philip Lange Møller,
Consultant, former GCP inspector
Philip Lange Møller, worked as a Medicines Inspector at the Danish Medicines Agency until July 2018 inspecting clinical trials on medicines and medical devices. He 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 led a clinical research team and was principal investigator – coordinating investigator – investigator-sponsor for clinical trials as well as medical advisor and clinical project leader in pharmaceutical companies.
Philip is a physician and graduated in 1988 from Aarhus University in Denmark. He trained in internal medicine and anesthesia until 1997.
Philip is a graduated physician in 1988 from Aarhus University in Denmark and trained in internal medicine and anesthesia until 1997.
