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” »

Big Data and Proactive Pharmacovigilance

Posted on September 20th, 2017 by in Pharmacovigilance

Traditionally thought of as a post-market process, pharmacovigilance is how pharmaceutical companies monitor and address any safety issues that arise once a drug becomes available commercially. However, some companies are now thinking ahead about these potential safety concerns with what is known as “proactive PV”. Continue reading “Big Data and Proactive Pharmacovigilance” »

The Challenges of Signal Detection in Spontaneous Reporting

Posted on September 13th, 2017 by in Pharmacovigilance

Pharmacovigilance is essential to pharmaceutical businesses. It facilitates the correct use of a drug, safeguarding the drug as a meaningful treatment option when the benefits it offers outweigh known risks, or measures can be taken to mitigate those risks. Continue reading “The Challenges of Signal Detection in Spontaneous Reporting” »

Taking a Balanced Approach to Monitoring Literature

Posted on September 11th, 2017 by in Pharmacovigilance

In a time when the focus on pharmacovigilance is greater than ever before, literature monitoring presents pharmaceutical companies with significant challenges. Pharmacovigilance groups are looking for ways to efficiently and cost-effectively manage an increasing workload while remaining compliant with regulatory best practices. Continue reading “Taking a Balanced Approach to Monitoring Literature” »

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