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 (IVD) 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 that the diagnostics and broader healthcare industries are undergoing.
Join this webinar 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.
Speaker
Ashleigh Dawley, RAC, Manager, Regulatory Affairs, Regulatory, Reimbursement and Market Access ICON plc
Ashleigh Dawley has over 6 years’ experience in Regulatory Affairs, specializing in in vitro diagnostic (IVD), companion diagnostic (CDx) and medical devices with a strong background in biochemistry. Dawley’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 commercialization strategies from a regulatory perspective. Dawley‘s experience in International Regulatory Affairs is of considerable note. Preparing complex global regulatory strategies, Dawley has proven results with successful submissions in North America, Asia Pacific, Latin America, the Middle East, Africa, and Russia. Dawley 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. Dawley graduated magna cum laude from California State University Channel Islands holding a Bachelor Degree in Communication.
Message PresenterWho Should Attend?
Anyone involved in the medical device or IVD industries, including medical device manufacturing personnel from:
- R&D
- Clinical operations
- Manufacturing
- Quality assurance
- Regulatory affairs
- Sales/marketing
- Executives, directors
- Product managers
- Senior managers
- Clinical research staff
- Scientists
What You Will Learn
- Overcoming the shortage of notified bodies (NB)
- Assessing product portfolios and quality systems
- Planning and implementing technical file remediation
- Managing the IVD lifecycle
Xtalks Partner
ICON
ICON plc is a global provider of outsourced drug and device development and commercialization services to pharmaceutical, biotechnology, medical device, and government and public health organisations. The company specialises in the strategic development, management and analysis of programs that support clinical development from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently operates from 98 locations in 40 countries and has approximately 15,200 employees.
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