Article 57 xEVMPD to IDMP/SPOR PMS Data Migration: are you ready?

The situation All Marketing Authorisation Holders (MAHs) in the European Union (EU) and the European Economic Area are required to submit information on their authorised medicinal products to the Article 57 database of the European Medicine Agency (EMA) in accordance with Article 57(2) of Regulation (EC) No. 726/2004. It is a legally binding requirement from …

Machine Learning for the benefit of Life Sciences

Machine Learning (ML) is a form of Artificial Intelligence (AI), allowing applications to learn from the data processed. This is in contrast to programming, which follows a defined route to write a specific computer program. During the absorption of data, the ML algorithms learn to produce better, more precise ‘models’. These ML ‘models’ are an …

EMA provides latest on Article 57

Action required before end of January 2021. Since 1 February 2020, when the United Kingdom withdrew from the European Union (EU), the UK has become a ‘third country’ as far as the EU is concerned. A withdrawal agreement has provided direction for the transition period, ending 31 December 2020 (European Commission, Notice to Stakeholders, 13 …