Safety

/Tag: Safety

New safety advice for excipients demands improved labelling information

New safety advice for excipients demands improved labelling information The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission’s guideline on ’Excipients in the label and package leaflet of medicinal products [...]

New safety advice for excipients demands improved labelling information2018-09-17T11:00:24+00:00

Good practice for documentation of safety variations

How to ensure good practices for documentation of safety variations By Ea Dige Ensuring good practices for documentation and management of safety variations, starts by optimizing the cooperation between your Regulatory Affairs (RA) and Pharmacovigilance (PV) functions. [...]

Good practice for documentation of safety variations2018-09-17T10:54:01+00:00