National Adverse Event Awareness Day

On March 24, we celebrate the National Adverse Event Awareness Day, promoted by the American Society of Pharmacovigilance. Over the last decades, scientific discoveries and technological advances have resulted in a staggering number of innovative or improved treatments (drugs, devices, vaccines and combination products). Supporting these advances is an ever-growing pool of passionate and talented PV professionals. Access to safety data is easier than ever before. Patients and the public are more educated about drug, vaccines and device safety. At JPCC Associates, we are being consulted much earlier in the development process to ensure that the right PV system is in place, sometimes even before the phase I program starts. This all sounds wonderful, however there are still fundamental areas of PV where attention is still needed:

 Well organized PV processes: Companies often underestimate the impact of inefficient processes for PV and other key functions. Poor processes result in increased costs, waste of precious resources and delays in providing innovative therapies to patients.

Performant PV Vendors: The overall quality and performance of PV vendors across the board is too often subpar. An ineffective/superficial RFP process, or a vendor qualification performed by auditors without PV expertise will result in unmet expectations, gaps in capabilities/compliance, and inflated costs.

Both examples have an impact on the ability for PV teams to focus on their only priority: patient safety.

Take action: Do your PV SOPs help you or hinder you? Based on the performance of your current PV vendor, what would you change in regard to your vendor qualification and selection process? It may be a good time to do something about it...