Pharmacovigilance

Pharmacovigilance is becoming more and more business critical. Ensuring the safest possible use of drugs is a company mission that is required by regulators and markets alike.  It is no longer enough to be able to report in a timely manner.  Drug safety processes must be 100% reliable, cost efficient and release management capability.  The aim? To create and implement an effective Risk Strategy for the new refocused regime.  WCI is able to define the future of drug safety and how to get there through transforming performance and compliance by improving processes.

If you would like further information about in work in pharmacovigilance please click on the pdf. link below.

Is your drug safety effective today and ready for tomorrow?

Much expectation and responsibility has been put on the shoulders of the Qualified Person for Pharmacovigilance (QPPV).  The dedication and commitment to the role has, in many organisations, established good oversight of operational processes across pharmacovigilance e.g. QPs have a Detailed Description of the Pharmacovigilance System (DDPS) in place to support the submission process, and operational metrics to ensure Compliance to Regulatory requirements. 

If you would like further information about our work with the QPPV role please click on the pdf. link below.

Are you keeping up with the evolution of the QP role?

WCI have developed the holistic Pharmacovigilance Audit.  Working with the global law firm, Sidley Austin LLP, with whom WCI have a strategic alliance, the Audit offers an unparalleled understanding of pharmacovigilance regulations.  So how can you ensure that your organisation will get a clean bill of health following your next Pharmacovigilance inspection?  For further information please click on the pdf. link below:

WCI's holistic PV Audit

We have taken a proactive approach to drug safety and in 2001 WCI founded pvnet, a neutral drug safety forum for leading life science companies.  To complement this, in 2006 WCI launched pvconnect the same forum but for mid sized life science companies.

If you would like further information about our pharmacovigilance forums, pvnet and pvconnect, please click on the pdf. link below.

Shaping the future of pharmacovigilance