EMA Commissions Independent Research to Prepare for Real-World Monitoring of COVID-19 Vaccines
EMA is engaging early with researchers to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real world, once authorized in the European Union. The Agency has signed a contract with Utrecht University as coordinator of the EU Pharmacoepidemiology and Pharmacovigilance Research Network, a public-academic partnership of 22 European research centers, to conduct the ACCESS (vACcine Covid-19 monitoring readinESS) project. The researchers will identify a Europe-wide network of data sources and examine their utility in monitoring the coverage, safety and effectiveness of COVID-19 vaccines.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
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Funding Cuts Threaten Diversity in Clinical Research
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