Nelson memo

The Nelson Memo: Igniting a Global Open Data Revolution

The landscape of scientific research is undergoing a seismic shift, driven by an urgent demand for transparency, reproducibility, and equitable access. At the epicenter of this transformation in the United States is the Nelson Memo, a policy directive rapidly accelerating the future of open science. With the National Institutes of Health (NIH)'s recent announcement (NOT-OD-25-101)…...
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MAPS 2025

MAPS 2025 Decoded: The Medical Affairs Playbook

At the MAPS Americas 2025 conference in New Orleans, one of...
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Medical Affairs 2.0: GenAI as the Catalyst for

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The Paradigm Shift from Traditional Scientific

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Which Regulatory Requirements Are Applicable to “Legacy” Devices?

Understanding the requirements for your medical device is vital in today’s market. But are these...
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Ensuring Alignment Across EU MDR Deliverables

How to avoid all these pitfalls and keep thriving in the EU Medical Devices market?...
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Plain Language in Plain Sight: Why Making It Easier for Patients to Access Content They Understand Pays Off

With so many different types of Plain Language Summaries, and the interchangeable terms used for...
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Simple Considerations before Determining S&P Objectives for Medical Devices

With all the things to consider with Medical Device Regulations, it's important to identify the...
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Medical Device Manufacturing: Risk-Based QMS Alignment for EU MDR

The latest EU-MDR guidelines are a step in the right direction, moving from a focus...
Plain Language Clinical Trial Summaries

Why Do Plain Language Clinical Trial Summaries Matter?

Did you know that the European Medicines Agency’s Clinical Trials Regulation comes into effect on...

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