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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?” »

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” »

Outsourcing PV: Key Decision Drivers

Posted on November 2nd, 2016 by in Pharmacovigilance

The decision to outsource some or all pharmacovigilance (PV) activities to an external vendor is the most common but critical decision for PV activities. Continue reading “Outsourcing PV: Key Decision Drivers” »

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