How Do Medical Affairs and Regulatory Affairs Professionals Co-Create The Regulatory Strategy From The Beginning?
New ways clinical trials and real-world studies will be conducted…
Virtual inspections will definitely be more common going forward, and the key is to be ready at all times – not only when the inspection is knocking on the virtual door!.
The organisation needs to be constantly inspection ready, not just when the inspectors are knocking on the door. In the future we will see more unannounced inspections.
IT is now a key integral part of PV and validation of IT equipment, security patching and oversight of vendors will be key. More inspections will be conducted virtually going forward and this will call for different ways of presenting data and interviews.
Real oversight of vendors is often overlooked, it is important to stress that tasks can be delegated but not responsibility.
Karsten Lollike is the Corporate VP and QPPV of Global Safety in Novo Nordisk, a position he has held since 2007. Karsten Lollike qualified as a medical practitioner in 1990, earned his PhD in 1997 and an E*MBA in 2008. He worked as a physician in haematology and orthopaedic surgery before becoming a researcher in cell biology. Karsten joined Novo Nordisk in 2000 and has since then he has held various management positions within Novo Nordisk in Development, Marketing, Quality, and Safety. Karsten is the Chair of the PV Atrium subgroup of the Danish Association of Pharmaceutical Industry and sits in the EFPIA Pharmacovigilance Expert Group. Karsten is a member of the board of PPS A/S. Karsten likes gardening, playing chess and basketball and has a keen interest in art and music.