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Pharma – The Last Word – Early Access Unlocked, navigating EU programs for pre-approval drug access
Manage episode 426046316 series 2916794
Вміст надано Hogan Lovells. Весь вміст подкастів, включаючи епізоди, графіку та описи подкастів, завантажується та надається безпосередньо компанією Hogan Lovells або його партнером по платформі подкастів. Якщо ви вважаєте, що хтось використовує ваш захищений авторським правом твір без вашого дозволу, ви можете виконати процедуру, описану тут https://uk.player.fm/legal.
In this episode Phil Katz and Hein van den Bos discuss early access programs in the EU, exploring the various types of programs, their practical implications, and the regulatory challenges. They delve into compassionate use programs, named patient supply, and the nuances of implementing these programs across different EU countries. The conversation also touches on the benefits and risks of early access, including potential ethical and reputational concerns.
The future episodes will focus on specific areas of the law, such as drug development, clinical trials, FDA compliance, and more, providing listeners with a detailed look at the complexities of pharmaceutical regulations and practical strategies for navigating them.
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