| Roche Sites Around the World | US Regulation History Class | IVDR as Always | Bay Area Bonanza | Roche Pandemic Palooza |
|---|---|---|---|---|
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What is Indiannapolis, IN
This Roche site is designated as Roche Diagnostics' US Headquarters
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What is Upton Sinclair's "The Jungle"
This 1906 novel shocked the public so much, that the Pure Food and Drug Act was established just 6 months after its publication.
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What is May 26, 2022
The exact date the IVDR came into force
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What is Silicon Valley
The region known as one of the most prominent Tech Hubs in the world
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What is 7am to 7pm local time
When at-home working hours became flexible, Roche implemented these core working hours
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What is Branchburg, NJ
This US site is the primary manufacturing location for Roche Molecular PCR products
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What is Tuskegee Syphilis Study
The US National Research Act was signed into law in response to the horrors discovered in this Clinical Study, the name of which includes its location.
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What is Performance Evaluation
The continuous process, the records of which include the SVR, APR, and CPR
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What is San Francisco and Marin
The two counties connected by the Golden Gate Bridge
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What is March 12, 2020
The date FDA granted Roche its first EUA for a SARS-CoV-2 test (within 5 days)
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What is Basel Switzerland
Roche CEO Severin Schwann calls this Roche Site his "home base"
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What is the Diagnostic Accuracy and Innovation Act (DAIA)
The proposed US legislation, which never became law, upon which the VALID Act was built.
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What is Expert Panel Consultation
The additional review procedure involved in IVDR Technical Documentation Assessment for a device that is "first of its type"
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What is Genentech
The company founded in the Bay Area, which is recognized as the first biotechnology company ever
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What is the 6800/8800 System
Roche famously launched the first Emergency Use Authorized (EUA) SARS-CoV-2 test in the US, which is run on this system/analyzer
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What is 6 sites
Including Roche pharma, how many Roche sites are located in California
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What is Thalidomide
FDA reviewer Dr. Francis Oldham Kelsey famously blocked the approval of this drug, sparing the US from the tragedy experienced in Europe
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What is Annex XIII Section 2.3.2
The Annex and Section that defines the contents of the Clinical Performance Study Plan (CPSP)
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What is 5
Number of professional sports teams based in the Bay Area (MLB, NHL, NFL, NBA)
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What is 12
The number of Roche SARS-CoV-2 tests
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What is Penzberg, Germany
This Roche site's 6,200 employees nearly rival it's hometown's population of 16,000 people.
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What is 1976
The year when the Medical Device Amendments were implemented
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What is "It Depends"
The correct answer to the question "Does IVDR apply"?
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What is 8
Number of Bridges spanning the San Francisco Bay and surrounding delta (within 1)
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What is BioFire
This Roche competitor was granted the first 510(k) for a SARS-CoV-2 detecting test
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