Pharmacovigilance (PA)

/Pharmacovigilance (PA)

For authorised medicinal products, the MA holder is required to keep the product information up to date with current scientific knowledge. The operational part of this is ongoing pharmacovigilance.
Among the tasks of pharmacovigilance are the management of Individual Case Safety Reports (ICSRs) both those received from the market and those collected by the regulatory authorities. Moreover, the QPPV should be available on a 24/7 basis and have extensive knowledge of all aspects of pharmacovigilance.

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

New Risk Management Plan (RMP) template becomes mandatory

The new Risk Management Plan format – a major improvement for generic and well-established products By Ea Dige On 30 March 2017 EMA published Revision 2 of the guidance on the format for RMPs with major revisions [...]

New Risk Management Plan (RMP) template becomes mandatory2018-09-17T10:58:30+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