Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark.
Bjorg has been with GSK since graduating and has held different roles within the Device Engineering Group.
In 2015 Bjorg moved into the late stage parenterals area as device lead for key GSK parenteral devices, working closely with internal GSK project teams and external partners.
She progressed into leading a device management team in January 2017, where she has had the accountability of project management and regulatory compliance for parenteral devices.
In February 2019 Bjorg moved into a key management role in CMC regulatory where she is responsible for the global regulatory and advocacy strategy for GSK’s portfolio of devices across modalities and lifecycle.
Outline: With the introduction of the EU MDR, pharma companies must ensure readiness for the implementation in May 2020. However, specifically for single integral medical products with a device component such as a pre-filled syring which are in scope via Art 117 there is still many unknowns. This talk will include an industry perspective as well as case studies of how MDR Art 117 readiness can be approached in this time of uncertainty.View Details