Overview

Between the COVID-19 pandemic and BREXIT negotiations, the rapidly approaching deadlines to comply with the new In Vitro Diagnostics Regulation (IVDR) may have a profound impact on market access to products and, ultimately, patient outcomes. Now more than ever, in vitro diagnostic manufacturers will need to prepare for the upcoming changes to the clinical and regulatory landscape.

Understanding current guidance and adapted regulations is the first step to navigating transformations the diagnostics, and broader healthcare industries are undergoing.

Join us to learn about today’s IVD regulatory landscape and discuss how manufacturers can develop strategies to ensure a successful transition to comply with the IVDR by the 2022 deadline, including:

  • Overcoming the shortage of NBs
  • Assessing product portfolios and quality systems
  • Planning and implementing technical file remediation
  • Managing the IVD lifecycle

Audience

Anyone involved in the medical device or IVD industries, including medical device manufacturer personnel from: R&D, Clinical Operations, manufacturing, quality assurance, regulatory affairs, sales/marketing, Executives, directors, product managers, senior managers, clinical research staff & scientists.

Presenters

Ashleigh Dawley, RAC

Manager, Regulatory Affairs, Regulatory, Reimbursement and Market Access ICON plc

Ashleigh Dawley has over 6 years’ experience in Regulatory Affairs, specialising in in vitro diagnostic (IVD), companion diagnostic (CDx), and medical devices with a strong background in biochemistry. Ashleigh’s expertise spans the complete product lifecycle including R&D, study design (analytical and clinical), quality control, regulatory strategy of complex products through global submission preparation/approval, as well as marketing and commercialisation strategies from a regulatory perspective. 

Ashleigh’s experience in International Regulatory Affairs is of considerable note. Preparing complex global regulatory strategies, Ashleigh has proven results with successful submissions in North America, Asia Pacific, Latin America, the Middle East, Africa, and Russia. Ashleigh is skillful in the preparation of both Clinical Evaluation Reports and Technical Files for EU CE marking for diagnostic and medical device products with working knowledge of both MDR and IVDR. 

Prior to joining ICON in 2017, Ashleigh was part of Dako, an Agilent Technologies Company, where she functioned as Global Regulatory Lead on development of immuno-oncology CDx devices. Working directly with pharmaceutical partners, Ashleigh oversaw regulatory strategy of multiple tumor indications including non-small cell lung cancer, melanoma, urothelial carcinoma, renal cell carcinoma, and carcinomas of the head and neck from design and development phases through commercialization for the device side globally. 

Ashleigh graduated magna cum laude from California State University Channel Islands holding a Bachelor Degree in Communication with an Emphasis in Health.