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Theranos founder Elizabeth Holmes guilty of fraud, says jury

pharmaphorum

They also used direct communication, marketing materials, media and financial statements, models and other information to defraud potential investors, according to the complaint. She admitted using pharma company logos – including Pfizer – on Theranos documents sent to investors, even though they had not endorsed the technology.

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2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives

ISPE

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.

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The 20 Key Moments in the 340B Program's 30-Year History

Omnicell

2003: Congress passed the Medicare Modernization Act (MMA), which included the creation of the Medicare Part D program. The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise.

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CMC Requirements for New Drug Registration in Latin America

ISPE

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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Air Speed Qualification: At Working Position or Working Level?

ISPE

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 link] The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 You may unsubscribe from these ISPE communications at any time. m/s up to 0.54 link] 9 a b Mason, W.,

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ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma

ISPE

In this constructive process, documentation regarding the decisions made are important to justify the model and explain-ability mechanism selection in an audit context.” Journal of Machine Learning Research 3 (2003): 1137–55. ChatGPT : “The solution should be made to meet its desired quality standards. “An The Keyword. Subbiah, J.

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Accommodating Multiple Modalities in the Same Facility

ISPE

Other industry best practices may not be formally documented in regulations or industry best practice guides, but should also be investigated as part of the assessment. Published 2003. You may unsubscribe from these ISPE communications at any time. The assessment may also identify perception concerns. European Commission.