Pharma R&D Today

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Building PV SOPs: Where to start?

Posted on March 17th, 2017 by in Pharmacovigilance

Having a set of operating standards defined through Quality Documents (QDs) is the only route to compliance and performance. QDs are defined as documents such as Policies, SOPs, Work Instructions (WINs), Manuals, Charters and Memo to File. Continue reading “Building PV SOPs: Where to start?” »

Crisis Prevention in Pharmacovigilance

Posted on October 12th, 2016 by in Pharmacovigilance

One of the challenging situations that Pharmacovigilance functions will have to manage one day or another is a pharmacovigilance crisis. Continue reading “Crisis Prevention in Pharmacovigilance” »

Did you just say Safety Governance Model?

Posted on May 27th, 2016 by in Pharmacovigilance

We usually tend to think that our overall compliance to regulations and fulfilling our ethical commitment to patient safety is best answered through an established set of Policies and SOPs. We design processes around regulatory mandates and adjust to the complexity of the enterprise as much as we can, feeling confident that all our bases are covered. Continue reading “Did you just say Safety Governance Model?” »