Bjørg Kaae Hunter, GlaxoSmithKline - Qepler Summits And Conferences

Bjørg Kaae Hunter

Regulatory Manager, Devices
Stevenage, United Kingdom

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.

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
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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2nd Annual Pre-Filled
Syringes Summit 2019

Enhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.
  • 04 Jun 2019
  • Barcelona, ES
  • Pharma
Day 1: Tuesday, 04 June 2019
CASE STUDY: EU MDR Art 117 Impact on pre-filled syringe manufacturer

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.

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2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
CASE STUDY: MDR Art 117 advocacy update.
  • Where are we with MDR Article 117 implementation? And what has been done from an industry advocacy perspective.
  • Key Industry comments/questions on EMA Q&A on MDR Article 117 implementation and interaction with EMA on this topic
  • Key Industry comments on EMA draft guideline on dossier requirement for drug-device combination products. And reflections on end to end control strategy
  • Industry position on clinical evaluation and labeling requirement for drug-device combination products
View Details