Pharma R&D Today

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The Four Cornerstones of a Pharmacovigilance Organization

Posted on May 8th, 2017 by in Pharmacovigilance

For small organizations, building a PV department from the ground up can be an exercise of trial and error, frustrating and costly. Being in growth mode means that there is not much time to anticipate and plan, as multiple high priorities compete for attention. Continue reading “The Four Cornerstones of a Pharmacovigilance Organization” »

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?” »

Outsourcing PV: Selecting your Partner

Posted on January 23rd, 2017 by in Pharmacovigilance

Once you know what functions and expertise you want to keep in house and what are the PV activities you want to outsource, the next challenge will be to identify potential partners and pick-up the one which will fit your PV needs for the years to come. Continue reading “Outsourcing PV: Selecting your Partner” »

Outsourcing PV: Core Competencies

Posted on December 7th, 2016 by in Pharmacovigilance

In a previous posting, we reviewed the drivers for the decision to outsource some or all pharmacovigilance (PV) activities. What activity to outsource is the next critical step. Continue reading “Outsourcing PV: Core Competencies” »

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