Bjørg Kaae Hunter, GlaxoSmithKline - Qepler Summits And Conferences

Bjørg Kaae Hunter

Device Engineering Manager
GlaxoSmithKline
Stevenage, United Kingdom
GSK

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 accountability of project management and regulatory compliance for parenteral devices.

Related Sessions:

Drug/Device Combination
Products Summit 2018

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2018
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 04 December 2018
BLOCK: NAVIGATING THROUGH REGULATORY COMPLEXITY.
CASE STUDY: Regulatory filings for DDC informed by a control strategy approach
  • An industry position on control strategy in support of filing
  • Impact of ISO standards and ICH guidance to align across industry and regulators including EU MDR.
  • Case study: Design Space and Control strategy approach aligned to global standards and guidance
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