Pharma R&D Today

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Why a reliable FAERS searching capability is essential for pharma companies

Posted on October 27th, 2017 by in Pharmacovigilance

In the description of the FDA Adverse Event Reporting System (FAERS), the agency states that “voluntary and mandatory reporting plays an important role in the FDA’s post-market safety monitoring.” Continue reading “Why a reliable FAERS searching capability is essential for pharma companies” »

The Liabilities of Pharmacovigilance Activities

Posted on June 21st, 2017 by in Pharmacovigilance

There is always a risk that any Pharmacovigilance (PV) activity, even executed with the highest business and ethical standards, and with the highest compliance results, could be challenged, sometimes many years later. As a member of a PV team, you may have to one day justify your actions in front of a group of plaintiff’s lawyers, Continue reading “The Liabilities of Pharmacovigilance Activities” »

What Are Best Practices in Literature Monitoring for Top-performing Pharma Companies?

Posted on June 14th, 2017 by in Pharmacovigilance

The health and safety of patients is of utmost concern to pharmaceutical companies, and strict regulatory requirements ensure that safety standards remain high. But pharmacovigilance becomes an ever more difficult and overwhelming practice Continue reading “What Are Best Practices in Literature Monitoring for Top-performing Pharma Companies?” »

Compliant Monitoring of Adverse Events

Posted on May 24th, 2017 by in Pharmacovigilance

Developing and maintaining a solid strategy for screening for adverse events is critical for every pharmaceutical company. Without one, an adverse event could be reported in scientific literature without the company knowing — and failure to report it to the regulatory authorities could result in a serious warning. Continue reading “Compliant Monitoring of Adverse Events” »

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