Remove 2024 Remove Compliance Remove Licensing
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“Thaw Out” with Pharma Thought Leaders at the 2024 Puerto Rico Pharmaceutical Summit: HPM Directors to Discuss Drug Approvals and Puerto Rico “Exportation” Best Practices

FDA Law Blog: Biosimilars

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

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NYSDFS Part 500 Cyber Amendments Finalized: What You Need to Know

Perficient: Drug Development

The NYSDFS Part 500 amendments signal a crucial shift in the financial services regulatory landscape and underscore the importance of robust governance, risk management, and compliance frameworks. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

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DFS500 Amendments: What You Need to Know

Perficient: Drug Development

These DFS500 amendments signal a crucial shift in the regulatory landscape, emphasizing the imperative for robust governance, risk management, and compliance frameworks across the financial industry. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

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7 Reasons Why 2024 Will be the Year of XM Cloud

Perficient: Drug Development

As we enter 2024, most of the conversations we have are focused on XM Cloud. Even if the hosting and licensing costs are close, the operational costs of managing a true SaaS offering vs. what you need to support PaaS makes it even more compelling. But XM Cloud will continue to be the main focus and growth driver in 2024.

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Healthcare, HIPAA, Sitecore and BAAs

Perficient: Drug Development

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. This is because under the covers it is actually using the same instance.

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Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Agency IQ

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. However, labeling requirements depend on the type of license of the medicine. license number.

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Article EMA Thank You New roadmap sets out U.K. device regulation timelines

Agency IQ

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K. both pre- and post-market.