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HMA / EMA task force report on role of big data for medicines regulation
HMA / EMA task force report on role of big data for medicines regulation
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HMA / EMA task force report on role of big data for medicines regulation
HMA / EMA task force report on role of big data for medicines regulation
Recommendations for a path towards understanding ‘big data’ in the regulatory context published today as part of a summary report of the HMA - EMA Joint Big Data task force.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019
At its monthly meeting, the PRAC recommended the precautionary suspension of fenspiride medicines due to a potential risk of heart rhythm problems.
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Report from HMA/EMA workshop on availability of authorised medicines
Report from HMA/EMA workshop on availability of authorised medicines
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Report from HMA/EMA workshop on availability of authorised medicines
Report from HMA/EMA workshop on availability of authorised medicines
EMA has published a report from its multi-stakeholder meeting on 9 November 2018 to gather perspectives on how to better address potential problems with the supply of medicines and avoid shortages.
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
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Updated guidance for industry on preparing for Brexit
Updated guidance for industry on preparing for Brexit
EMA and the European Commission provide additional information to help pharmaceutical companies prepare for the UK’s withdrawal from the EU.
