- Philip Lange Moeller
- Senior GCP Specialist, Auditor and Adviser
- Møller&Juhl IVS, Denmark
Philip Lange Moeller is senior GCP specialist, auditor and adviser. Philip is highly qualified keynote speaker at different international clinical conferences. Philip was a GCP Inspector at the Danish Medicines Agency in 12 years inspecting clinical trials on medicines and medical devices. He had 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 had been a member of the EMA GCP Inspectors Working Group. Prior to joining the Danish Medicines Agency, Philip had 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.
- Thuy Diem Larsen
- Senior GCP Adviser
- PharmaGCP, Denmark
Thuy Larsen is senior GCP adviser at PharmaGCP and an experienced consultant with more than 17 years within clinical research and device/pharmacovigilance. She has an extensive knowledge and experience in several clinical trial processes such as GCP audit/inspection, Quality Management System (QMS), SO P writing, protocol, informed consent, monitoring, IMP labelling/packaging, IR T set-up and safety reporting. Thuy holds a Master of Pharmacy in 2000 from Copenhagen University and has been working for different pharmaceutical companies such as Novo Nordisk (14 years) and as consultant at Ferring, ALK Abello and Klifo A/S (3 years). Thuy is an experienced trainer in clinical trial processes. Before working in pharmaceutical companies, she was a part-time teacher in pharmacology in a period of 2 years.