Season 2, Episode 5
PathVisions 2021 and Regulatory update for 2021
This episode's guests: Esther Abels
Our guest is Esther Abels, Chief Clinical and Regulatory Officer at Visiopharm, President Elect DPA
Esther also leads the regulatory and standards task force at the DPA with a focus on FDA collaborations to drive regulatory and standard classifications for interoperability and computational pathology in the field of digital pathology.
We're going to be talking about standardization in digital pathology - not only in preanalytical factors such as fixation and staining - but also in the interpretive or analytic component, as well which is becoming increasingly important to ensure optimal diagnostic results for patients and incorporation of digital pathology data into diagnostic and drug discovery programs.
We discuss regulation. What are some misconceptions about regulation how can we use regulation as a tool to protect patients and better develop and provide products and services? And how can we partner with regulators to help advance the science.
What is the DPA working on now and what is their long-term vision for the future of the field? The annual meeting of the Digital Pathology Association, Pathology Visions is going to be held this October in Las Vegas.
More About Esther Abels
Esther Abels, Chief Clinical and Regulatory Officer at Visiopharm, President Elect DPA
Esther Abels has a background in bridging R&D, proof of concept, socio economics and pivotal clinical validation studies used for registration purposes in different geographies, for both pharma and biotech products. She has a wealth of regulatory and clinical experience specializing in bringing products to clinical utility.
She played a crucial role in getting WSI devices reclassified in USA.
Esther currently is the president elect for the Digital Pathology Association (DPA) and leads the Regulatory and Standards Taskforce with a focus on FDA collaborations to drive regulatory and standard clarifications for interoperability and computational pathology in the field of digital pathology.
She is also a co-founder of the Pathology Innovation Collaborative Community and leads the Reimbursement Workgroup.
Esther holds a MSc in Biomedical Health Science from Radboud University Nijmegen