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Simplified Adverse Event Reporting in Europe – Are You Prepared for the Switch Over?
Since the introduction of the pharmacovigilance legislation in 2010, a commitment to a simplified approach to adverse event reporting was introduced by the EMA (Articles 107(3) and 107a(4) of Directive 2001/83/EC). This approach would only apply however following an independent...
Brexit & Regulatory Affairs – The UK Is Heading for the Exit
In an extract from our second Brexit whitepaper, we look at the impact of Brexit on regulatory affairs and issues such as the future of the European Medicines Agency, Pharmacovigilance and Brexit and much more.