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Erica Conway, BSc, PhD (she/her/hers)

Director, Precision Medicine & Digital Health, Global Regulatory Affairs
GSK, England, United Kingdom

Dr Conway has over 20 years of regulatory affairs experience, primarily within In Vitro Diagnostic (IVD) medical devices. Dr Conway joined GSK in November 2024 as Director, Precision Medicine & Digital Health, Global Regulatory Affairs. Dr Conway joined GSK from MCRA, a consultancy firm, where she was VP IVD Regulatory Affairs - Europe for two years. Prior to this, she was Head of IVD Notified Body (NB) at BSI, where she was pivotal in the implementation of the IVD Regulation (IVDR, (EU) 2017/246) and the successful designations of both the UK and the Netherlands organizations. Dr Conway represented IVD Notified Bodies at MDCG IVD Working group meetings, where she contributed to the development of IVD MDCG guidance, as well as representing NBs in meetings for the development of the Companion Diagnostics consultation process as well as meetings with agency stakeholders on procedures for Class D IVDs under IVDR.

Dr Conway’s industrial experience started in the regulation of pharmaceuticals for GSK, before moving into clinical trials for medicinal products for a CRO. Dr Conway moved into the field of IVD medical devices in 2006 for Axis-Shield Diagnostics (now Abbott Rapid Diagnostics) before becoming an independent consultant. Dr Conway joined BSI in 2014 as a Technical Specialist/Scheme Manager in the IVD medical devices team before assuming the role of Global Head of the IVD Team in 2016, leading the IVD Technical team for operational delivery of Technical Documentation assessments, expanding the team to meet the increased resource demands under the IVDR, and final decision making for CE certifications. Dr Conway moved into the position of Head of IVD NB, where she was responsible for the overall compliance of the NB (and UKAB) for certification of IVDs. Dr Conway has since been using this IVDR experience in her subsequent roles.

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