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WEBINAR - EUA Pathways
The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
This webinar will be recorded.
TOPIC: EUA Pathways
TOPIC DESCRIPTION: FDA Regulatory pathway for Emergency Use Authorization of COVID-19 test/assays.
The COVID-19 pandemic was, and is still, a big catalyst. Regulatory flexibility is required. Regulatory Agencies such as the FDA have adapted to the evolving COVID-19 pandemic. Many guidance and policies have been enacted, and regulatory flexibility has ensured accelerated access to drugs, devices, vaccines etc. This also includes the tests/assays necessary to develop these treatments. Pashmi Vaney, Sally Howard, and Dr. Tera Eerkes will review the current landscape of the submission pathway for COVID-19 tests/assays including approval of a novel immune response test.
SPEAKERS: Pashmi Vaney, Sally Howard, and Tera Eerkes
SPEAKER BIOGRAPHY:
Pashmi Vaney is the Senior Manager Regulatory Affairs at Adaptive Biotechnologies. In this role, she leads and supports regulatory strategy and activities for submissions and ongoing investigational studies in the US. She has 8 plus years of experience with FDA pre-Submissions, EUA, 510(k)s, PMA ( CDX), EU Technical Files, PMDA, Health Canada Device License submissions and amendments, development of labeling and promotional material, UDI barcode labeling, and product development team support. In 2020, she led the FDA Emergency Use Authorization for Adaptive Biotechnologies' T-Detect COVID test. Pashmi earned a Master of Science degree in Regulatory Affairs from the University of Washington and a Medical Degree from India. She was a practicing family physician in rural Delhi, India, prior to coming to the United States.
Sally Howard, JD,is the Vice President of Regulatory, Health Policy, and Quality at Adaptive Biotechnologies, a commercial-stage biotech company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease. Prior to joining Adaptive in January 2020, Sally was Vice President of Regulatory and Quality at Human Longevity, Inc. Sally was Deputy Commissioner at the U.S. Food and Drug Administration from 2013-2015, where she led FDA's role in President Obama's Precision Medicine Initiative, and coordinated policy development across FDA. Sally was also Chief of Staff at HHS under Secretary Sebelius, and HHS Deputy General Counsel. Sally received her juris doctorate from the University of Kansas, and her Bachelor of Arts from Kansas State University.
Dr. Tera Eerkes is currently serving as a Sr. Director, Regulatory Affairs at Adaptive Biotechnologies where she has contributed to the development of diagnostic products including IVD applications for NGS immune-sequencing diagnostics. Her career focus has been leading cross-functional teams to strategically translate emergent novel genomic technologies into market-ready products. Prior to joining Adaptive Bio., she co-founded or contributed to multiple genomic diagnostic companies, including Resolution Bioscience, Iverson Genomics and iGenix Inc., delivering efficient product development and implementing best-in-class diagnostic operations. Dr. Eerkes received her B.S. in Computer Science from the University of Colorado, and her Ph.D. in Molecular Biotechnology from the University of Washington.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification
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