Pharma R&D Today

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The Importance of the Safety Management Plan for Clinical Trials

Posted on June 30th, 2017 by

In a world where many operational and strategic clinical trial activities are outsourced to Contract Research Organizations (CROs), the design and content of the Safety Management Plan (SMP) will greatly influence the execution of clinical trial drug safety activities. Continue reading “The Importance of the Safety Management Plan for Clinical Trials” »

The Liabilities of Pharmacovigilance Activities

Posted on June 21st, 2017 by

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

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?” »

Shouldn’t pharmacovigilance be less painful?

Posted on May 26th, 2017 by

PV white board

Even with advanced information technologies, too many companies and pharmacovigilance practitioners are still living with the pain of having to rely on ineffective and outdated systems and processes. Continue reading “Shouldn’t pharmacovigilance be less painful?” »

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