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Ensuring Your Organization is Prepared for the Implementation of the EU Clinical Trial Regulation

PPD

The European Union Clinical Trial Regulation (EU CTR) brings the biggest change in the regulatory landscape since the implementation of the EU Clinical Trials Directive in 2004, requiring vast changes in the way organizations are structured and conduct their day-to-day activities.

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AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents

Agency IQ

BY COREY JASEPH, MS, RAC With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

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Ships now spew less sulfur, but warming has sped up

Science Daily: Pharmacology News

New findings document fewer ship tracks, reduced cloud cover, and boosted warming after ship emissions regulations took effect in 2020.

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In new report, FDA sketches out ideas for improving how it publishes guidance documents

Agency IQ

In a long-anticipated draft report, the FDA has offered a vision for a series of potential improvements to the way it currently publishes guidance documents. Fill out the form to read the full article.

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The 53 regulations that FDA is currently working on

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond.

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The 103 regulations the EPA is currently working on

Agency IQ

BY WALKER LIVINGSTON, ESQ On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

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The Use Case for Synthetic Data and Document Generation: Accelerating Digital Transformation Through Efficient Testing

Perficient: Drug Development

One use case organizations can consider is Synthetic Data and Document Generation, which allows companies to automate the creation of synthetic (or fake) data for testing purposes, therefore accelerating their digital transformation initiatives. What Is Synthetic Data and Document Generation?