Your case back log has reached critical levels? Data lock of your next Periodic Safety Update Report (PSUR) was a week ago, but you have found out only today? Your regulator wants a Risk Management Plan (RMP)? You assume that an inspection is coming up for your pharmacovigilance (PV) function, but you are uncertain how your PV system will endure a critical review? Your Qualified Person responsible for Pharmacovigilance (QPPV) is leaving or unavailable for a longer period of time?
offers support and solutions in these and similar circumstances.
Accessing solutions is generally simple and delivery of our services is timely, following your phone, written, or personal prescription.
The PV System and its PSMF are essential obligations for any EU Marketing Authorisation Holder.
The QPPV plays THE leading role in EU PV – similar to the Graduated Plan Officer in Germany.
Not optional, not easy to implement: PV Compliance has turned into a continuous burner.
The ’if’ of PV system audits (including all its components) has been answered (yes); the ‘how’ however remains a difficult topic for many of those responsible.
RMPs are needed for nearly every new EU drug marketing authorisation. They are also due with every PV relevant variation. But how do you bring cost efficiency and compliance together?
‘Aggregate Reports’ are about product overview, about a current evaluation of the safety profile and the benefit / risk ratio.
The development of effective, meaningful, and sustainable PVAs is one essential way of dealing with the complexities of a PV system.
PV data from clinical studies are of particular importance for safety profile evaluation: Nowhere else are data of this quality available.
Managing Drug Safety Monitoring Boards, Pharmacovigilance training, Management Coaching, Strategic PV Consultancy and much, much more.