Mya thomae

Author: pvde

August undefined, 2024

WebThomae is currently Vice President of Regulatory Affairs at Illumina, which acquired her regulatory and quality consulting firm in 2014. “Mya Thomae is a terrific addition to our Board, and we are very happy to have her as a director,” … WebJul 16, 2014 · Myraqa Founder and CEO Mya Thomae will become the vice president of regulatory affairs at Illumina and report to Illumina CMO Rick Klausner, who said that Myraqa will complete its existing programs and continue working with "selected third-parties" on sequencing-based projects. ... adding Thomae "will lead Illumina's regulatory strategy and ...

Thomas College

WebMya founded Myraqa (formerly Mya Thomae Consulting) in 2002, building on several years as an independent contractor. Listen to the interview: Diagnostics and the Evolution of the … WebMya has worked with FDA and many worldwide regulatory agencies on a variety of technologies, sample types and disease states. She has obtained clearances and … starlight 14.25 luxury plush mattress

Illumina Acquires Myraqa, a Leading IVD and Companion …

WebMar 7, 2024 · Mya Thomae is a Vice President, Regulatory Affairs at GainClients based in Tucson, Arizona. Previously, Mya was a Manager, Regulatory Affairs at E pitope and also … WebSep 19, 2013 · Below is the transcript from the video discussion between Paul Tunnah and Mya Thomae, an expert on in vitro diagnostics, where she explains the language around … WebLatest on Maryland-Eastern Shore Lady Hawks guard Mya Thomas including news, stats, videos, highlights and more on ESPN peter drucker articles on leadership

What’s Next for NGS Regulation? - Illumina, Inc.

Illumina Acquires CDx Firm Myraqa Technology Networks

WebMya Thomae Mya has been working in regulatory, quality and clinical affairs for in vitro diagnostic products since 1990. Mya has worked with FDA and many worldw… Full Bio Stefan M. Pfister, MD Stefan M. Pfister, Prof. Dr. med. Director Preclinical Pediatric Oncology Hopp Children’s Cancer Center Heidelberg (KiTZ) Division Head “Pediatric Ne… WebJul 18, 2014 · Led by founder and CEO Mya Thomae, Myraqa focuses on regulatory strategy. Illumina Acquires Myraqa, a Leading IVD and Companion Diagnostic Consulting Firm Acquisition Strengthens Illumina’s Clinical Readiness SAN DIEGO--(BUSINESS WIRE)--Jul. 16, 2014-- Illumina, Inc. (NASDAQ:ILMN) today announced that it has acquired Myraqa, a … peter drucker effective executive pdfWebDec 4, 2013 · Mya Thomae has been helping companies comply with FDA regulations for 20 years. Mya is intimate with how the FDA works and laments that the diagnostics industry, as opposed to the regulated therapeutics industry, has been on a "race to the bottom." She doesn't hesitate when asked whether the 23andMe test is a medical device. starlight 14

"WebDear Ms. Thomae: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval … " - Mya thomae

Mya thomae

WebAccording to Mya Thomae, CEO of IVD and companion diagnostic consulting firm Myraqa, the latest version of the guidance is more enforceable than its earlier iteration. "FDA has focused on intended use and has defined what the real limits of RUO labeling are," said Thomae. On a Myraqa blog post about the RUO/IUO guidance, Thomae elaborated that ...

Did you know?

WebMya Thomae is 55 years old and was born on 04/02/1967. Before moving to Mya's current city of Hartland, WI, Mya lived in San Francisco CA. Sometimes Mya goes by various nicknames including Myn B Johnson, Barbara J Thomae, Barbara Thomae, Mya B Thomas and Mya B Thomae. WebMya Thomae. PMID: 21877885 DOI: 10.4155/bio.11.174 No abstract available. Publication types Editorial MeSH terms Biomarkers / analysis* Clinical Laboratory Techniques / methods* Female Humans Male ...

WebJul 16, 2014 · The deal is intended to strengthen Illumina’s in-house capabilities to expand genomic technology into clinical settings and prepare for its next growth phase, the … WebBiography. Mya has extensive experience in gaining regulatory approvals for novel IVDs in the United States and Europe. This work has included PMAs, 510 (k)s and de novo 510 …

WebMya Thomae is Illumina’s Vice President of Regulatory, Clinical and Medical Affairs. Mya has more than twenty years of experience as a regulatory professional including founding and … WebJun 9, 2015 · market, today announced that Mya Thomae has been named to its Board of Directors and Harjit Kullar, PhD, has been appointed Vice President of Marketing for the …

WebJun 8, 2011 · Mya Thomae, CEO of diagnostics consulting firm Myraqa, who previously worked with the FDA on developing regulation for microarray devices and establishing rules for parallel 510(k) submissions, believes the RUO/IUO guidance will be "a painful transition" for companies that have gotten used to conducting business under FDA's lax enforcement …

WebJun 9, 2015 · Transgenomic has elected Mya Thomae to its board of directors. She is currently vice president of regulatory affairs at Illumina. Before that, she served as CEO of … peter drucker knowledge worker definitionWebSep 19, 2013 · Mya founded Myraqa (formerly Mya Thomae Consulting) in 2008, building on several years as an independent contractor. Myraqa is the leading IVD regulatory consulting firm. Founded in 1998 as a... starlight1668WebJul 26, 2014 · Illumina Inc has acquired Myraqa, a regulatory and quality consulting firm specializing in in vitro diagnostics, with emphasis on companion diagnostics. Led by … peter drucker leadership philosophyWebMay 27, 2015 · Mya Thomae: FDA defines companion diagnostic pretty narrowly. FDA defines a companion diagnostic as a specific in vitro diagnostic device that provides … starlight 14 moviesWebJul 16, 2014 · Myraqa is led by CEO Mya Thomae, who will lead Illumina’s regulatory strategy and execution, said Rick Klausner, chief medical officer of Illumina. “With Myraqa, Illumina will continue to pave the way for the use of genomic technology, including next-generation sequencing, in regulated markets while also driving standards for use in the ... starlight 14 charlotteWebMya Thomae is on Facebook. Join Facebook to connect with Mya Thomae and others you may know. Facebook gives people the power to share and makes the world more open … starlight 14 anderson scWebJul 16, 2014 · Led by founder and CEO Mya Thomae, Myraqa focuses on regulatory strategy and application support, including PMAs, pre-submissions, IDEs, 510(k)s, de novo 510(k)s, and EU technical files. The acquisition will bolster Illumina's in-house capabilities for clinical readiness and help prepare for its next growth phase in regulated markets. starlight 16x resource pack download