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Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Data governance and HIPAA rules around this are very clear—you can’t identify the individual. Switzerland Platform’ .

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Clinical Research News: Social Determinants Of Health Data Help Identify Sites For Trials

Clarify Health

It has been more than a decade now since the notion of social determinants started expanding to consider access to transportation, food, income, and decent housing on care journeys and outcomes, says Drouin. Data governance and HIPAA rules around this are very clear—you can’t identify the individual.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.”

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Uri Goren

Cadensee

48:12 What is Uri Gorenseeing that is special in the Israeli Digital Health ecosystem? It might be silly question but bringing a drug to market takes many, many years. So, do you listen to them at the point when a pharma company decides what drug it needs to make? When do you think it is the most important?

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FDA AdCom votes unanimously in favour of OTC oral contraceptive

Pharmaceutical Technology

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of giving HRA Pharma’s Opill (norgestrel) over-the-counter (OTC) availability. The FDA approved Opill for prescription use in 1973. The therapy only contains the hormone progestin and is taken once daily.

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