What to Expect for the Future of Regulatory
Thursday, January 26, 2017 | 1 – 2 PM EST
Director Quality & Regulatory and Medical Affairs
Digital pathology is seen as bringing flexibility in the workflow and facilitating the pathologist to easier share information. DP has the potential to enhance cancer diagnostics by for example data mining, building a database of clinical diagnostic information or providing a path towards giving quantitative support.
Currently WSI systems are defined as consisting of an image acquisition subsystem producing a digital image file, and a workstation environment for viewing the digital images. With this definition and each WSI device producing its own file formats, it has regulatory and practical challenges. The Digital Pathology Association (DPA) Regulatory Task Force is committed to clarify regulatory pathways for example of algorithms and seeking opportunities to facilitate the workflow. During this webinar we will discuss these challenges.
Esther Abels, MSc, Dir Q&R and Medical Affairs Philips Digital Pathology Solutions. Graduated in Biomedical Health Science, toxicology. Experienced in clinical validation studies used for regulatory purposes in USA, Europe and Asia. Has a background in bridging R&D, Proof of Concept and socio economics studies. Was Clinical Research Scientist and Global Clinical Trial Manager for pivotal regulatory studies in pharma. Worked and lived in NL as well as USA prior to joining Digital Pathology Solutions in 2011. She played a crucial role in the 510(k) clearance and started the regulatory process for WSI “Primary Diagnosis” for DPS, and in the Digital Pathology Association (DPA) Regulatory Taskforce and agency collaborations with a successful outcome that WSI for primary diagnosis is recommended to become a class II instead of class III device in USA. Currently Chair of the DPA Regulatory Taskforce.