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Due to COVID-19, understandably most inspections are now done remotely, but that also goes hand in hand with a different preparation needed.

How to ensure that your pharmacovigilance system meets European regulatory requirements?

Thorough review EU GVP Modules and confront them with company procedures.

What do you see as the number one necessity in developing and maintaining a PSMF for your products?

Build strong relations and have appropriate training for all PSMF contributors.

Has the current situation affected the process of EU regulatory inspections?

Most inspections are now conducted remotely. Organisation and preparation is different for virtual inspections and self-inspections/mock inspections can be useful to be prepared to this new set-up.

Gabrielle AMSELEM, Deputy EUQPPV – PSMF Manager from Alexion, got a pharmaceutical degree from the University Paris-Sud in France and has a 4-year experience in pharmacovigilance. At Alexion since 2016, she has taken up different roles, first being the Local Safety Officer for France then appointed as deputy EU QPPV. Gabrielle coordinates compliance activities within the QPPV office (for EU and ex-EU local QPPVs) and manages PSMF (EU and ex-EU requirements).

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