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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Öppen frågestund: Regulatory Opportunities for Rare Diseases/Orphan Products in US and EU
Anmäl dig till vår nästa session av Office Hours den 28 februari klockan 15:00 (svensk tid), en öppen frågestund om utveckling av särläkemedel (orphan drugs).
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Webinar: Clinical evaluation and clinical investigation of medical devices
Whether you are a small medtech company or a large one, this webinar is a must-attend for anyone curious about how clinical studies on medical devices are conducted.
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Webinar: How to Plan And Analyze a Real-World Evidence Study
This webinar is for drug developers who want to understand the basic ideas of analyzing an RWE study, as well as avoiding the most common pitfalls.
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Webinar: Medtech quality and regulatory compliance
This webinar is for you who are developing or planning to develop a medical device, combination, or borderline product. In one hour, we will discuss what you ne...
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RegSmart och UIC i partnersamarbete
RegSmart och UIC har tecknat ett partneravtal från 1 februari 2023. RegSmart stöttar UIC-bolag inom Life Science med rådgivning inom regulatoriska frågor samt b...
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Vårwebinarier om statistik och regulatory affairs
SDS anordnar två webinarer under april och maj med fokus mot statistik och regulatory affairs
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EU Pharmaceutical Legislation Reform
The EU's Pharmaceutical Legislation Reform, proposed by the commission within the European Health Union, aims to establish a citizen-centric framework to enhanc...