Risk Management & Pharmacovigilance

UBC - May 13, 2014
Every day, sponsors are challenged to ensure patient safety and meet complex regulatory requirements. Increasingly, sponsors of all sizes are collaborating with trusted outsourcing partners to assist with pharmacovigilance. Such...
UBC - April 30, 2014
With sunny 70 degree weather, 40+ museums, 6,400 restaurants, and 92 golf courses, we don’t need to be told twice to travel to San Diego. And this June 16 – 18th we have a great reason to pack our suitcases – the DIA 2014 50th Annual...
UBC helps design and implement natural history of disease studies
UBC - April 28, 2014
In-depth study and understanding of the disease or condition for which a drug or biologic is being developed is essential to the scientific foundation of any clinical development program.  That’s why incorporating a natural...
UBC offers electronic data transfer to FDA
Michael Jacquinto, Sr. Manager, Pharmacovigilance - April 24, 2014
Pharmacovigilance reporting is governed by a strict timeline.  Unexpected fatal or life-threatening expedited clinical trial individual case safety reports (ICSRs) must be submitted to the FDA and other regulatory authorities as...
Wenda Brennan, RPh Director, Pharmacovigilance US - April 18, 2014
As the drug safety landscape shifts, so do the methods for AE reporting. Traditional sources of adverse event reporting include clinical trial investigator site and post marketing medical information call center.  However,...

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