Pharmacovigilance legislation requires that marketing authorisation holders shall establish and maintain an adequate and effective pharmacovigilance system. In an ever-changing regulatory and business environment, maintenance of a system that is both regulatory compliant and proportionate to your organisation is a challenging task. Building on years of hands-on experience, we offer the following system and process consulting services:
The challenge: In the context of a major corporate reorganisation, a large, globally operating pharmaceutical company requires re-designing of all pharmacovigilance processes to suit the future environment. The set of new written procedures is required to be agreed, written, approved, trained and effective within 8 months.
Our contribution: In close co-operation with client subject matter experts and senior pharmacovigilance management, Mark Waring Pharmacovigilance Services reviews and re-designs all pharmacovigilance processes, and authors more than 20 corresponding SOPs. The project is completed on schedule.
The outcome: The revised pharmacovigilance system proves fit for purpose in daily business, audits and inspections, with only minor modifications in the following years.
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