PV Inspections – experiences from a company perspective

The last couple of years the concept for how the Danish Medicines Agency is conducting PV inspections at Pharmaceutical Companies in Denmark has changed. Last year at the conference, DKMA presented their current approach for PV inspections which includes three separate tracks; one for Pharmacovigilance, one for Clinical Trials and one for IT systems. This year, we have the opportunity to share with you experiences and learnings from a company perspective after a recent PV inspection.

About the speaker
Caroline Susanne Sandström Msc PhD

Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. Her special interest for chronic inflammation, pharmacology and immunology was reflected in the thesis which was dealing with both human and murine-based systems.

She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects. Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. She was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture.

After almost seven years in Novo Nordisk A/S, Caroline Sandström started as Compliance Director at Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she is involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She is taking a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area.

Her scientifically driven problem solving skills are today used for implementing global cross-functional compliance projects, supporting and strengthening the quality mindset in the organization.

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