Introducing The Unshakeables, a new podcast from Chase for Business and iHeartMedia's Ruby Studio. Small businesses are the heart and soul of this country, but it takes a brave individual to start and run a company of their own. From mom-and-pop coffee shops to auto-detailing garages -- no matter the type of industry you’re in, every small business owner knows that the journey is full of the unexpected. A single moment may even change the course of your business forever. Those who stand firm ...
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Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight
Manage episode 342283600 series 1533910
内容由K&L Gates LLP and L Gates提供。所有播客内容（包括剧集、图形和播客描述）均由 K&L Gates LLP and L Gates 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品，您可以按照此处概述的流程进行操作https://zh.player.fm/legal。
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.
100集单集
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Manage episode 342283600 series 1533910
内容由K&L Gates LLP and L Gates提供。所有播客内容（包括剧集、图形和播客描述）均由 K&L Gates LLP and L Gates 或其播客平台合作伙伴直接上传和提供。如果您认为有人在未经您许可的情况下使用您的受版权保护的作品，您可以按照此处概述的流程进行操作https://zh.player.fm/legal。
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device clinical trials, sponsor obligations for investigator-initiated studies, and compliance for expanded access INDs and for GMPs in the case of hospital manufacturing of cell culture products and 3D printing.
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类似 K&L Gates Health Care Triage 的节目
Introducing The Unshakeables, a new podcast from Chase for Business and iHeartMedia's Ruby Studio. Small businesses are the heart and soul of this country, but it takes a brave individual to start and run a company of their own. From mom-and-pop coffee shops to auto-detailing garages -- no matter the type of industry you’re in, every small business owner knows that the journey is full of the unexpected. A single moment may even change the course of your business forever. Those who stand firm ...
…
continue reading
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…
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…
continue reading
Wharton faculty and industry leaders discuss their latest research, books, and relevant business topics. Hosted on Acast. See acast.com/privacy for more information.
…
continue reading
Alessandro Bogliari, CEO and Co-Founder of The Influencer Marketing Factory, a global influencer marketing agency, talks with great guests about influencer marketing, social media, the creator economy, social commerce and much more.
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continue reading
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How can business help solve society’s biggest challenges? Welcome to Series 3 of Take on Tomorrow, the award-winning podcast from PwC that examines the biggest problems facing society and the role business can—and should—play in solving them. This series, we’re welcoming broadcaster and journalist Femi Oke to the show. She joins podcaster and journalist Lizzie O’Leary, and together with industry innovators, tech trailblazers and visionary leaders from around the globe, they’ll explore timely ...
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continue reading
In each episode of "Goldman Sachs Exchanges," people from the firm share their insights on developments shaping industries, markets and the global economy.
…
continue reading
It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
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continue reading
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Player FM -播客应用
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使用Player FM应用程序离线！
