Pharma R&D Today

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The Changing Competencies of Pharmacovigilance Leadership

Posted on June 27th, 2016 by in Pharmacovigilance

Significant transformations happened over the last decade regarding the role of pharmacovigilance (PV) departments in pharmaceutical organizations. This had a tremendous impact not only on the technical knowledge needed, but more importantly on the non-technical competencies that should be required for any PV role in pharma. (more…)

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. (more…)

Innovative Repurposing: New Drugs From Old

Posted on May 26th, 2016 by in Chemistry

Re-purposing of drugs is fraught with challenges, but can they be overcome so that patients benefit? The term re-purposing is often associated with the idea of saving a few bucks by taking something old and turning it into something useful (like transforming an empty wine bottle into a bird feeder). In the pharmaceutical world, though (more…)

Pharmacovigilance events in different regions cover common concerns

Posted on January 7th, 2016 by in Pharmacovigilance

In December, Elsevier sponsored the 11th Annual Pharmacovigilance, Drug Safety and Risk Management conference in Brussels, Belgium and the 2nd Adverse Event Reporting and Safety Strategies Summit in Philadelphia, USA.  (more…)

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