At a roundtable we recently facilitated on the topic of managing PV partners and associated agreements, we discussed with industry experts the best practices and lessons learned. This topic was fresh on all of our minds, particularly in a year where remote coordination was mission critical. Managing Decentralized PV Organizations The first area of focus
The distributed nature of aRMMs is a key challenge to implementation: it requires having a cohesive strategy and plan for implementing local RM activities. As was quickly pointed out, the effectiveness of RM programs is dependent on how well the programs are implemented at the local country level.
Read PRA Health Sciences’ quarterly newsletter here: Pharmacovigilance Newsletter The Feith Systems and PRA Health Sciences partnership delivers efficient tracking solutions to PRA’s clientele while supporting their pharmacovigilance services. This quarter’s PRA Newsletter outlines how PRA uses Orbit to manage and track their global pharmacovigilance processes, including Signal Management, Risk Management and Risk Minimization, and
From evaluating effectiveness to tracking global implementation status, and rooting out non-compliance with SOPs at your favorite affiliate, collecting data has become a necessity for Tracking Systems.
The new integration will support Patient Safety organizations as they define their safety data evaluation strategies
Dan Feith of Orbit recently co-presented a webinar with Carla Perdun Barrett of PRA Health Sciences. The webinar recording is available here. The webinar abstract is described below. Over the last decade, pharmacovigilance professionals have witnessed a significant shift in risk management activities with regard to updated guidelines and regulations beyond North America and Europe.
Risk-based MHRA inspections and a possible end in sight for standalone signal detection in Eudravigilance…
Takeaways from the PV & Risk Management Strategies meeting
It’s January, and that means we are gearing up for DIA’s Annual Pharmacovigilance and Risk Management Strategies Conference (PVRMS). We set aside time to review this year’s agenda, and we are looking forward to listening and learning as part of this growing community of drug safety professionals. If this is your first PVRMS conference, here
Reflecting back on the busy week with the Feith Team reaffirmed how valuable Orbit software is in solving the ongoing challenges in tracking Pharma’s complex procedural activities. Speaker & Poster Sessions: Seemed to be a general trend across presentations involving innovative initiatives that shift Pharma activities from being volume-based to value-based. Here’s a few of
Our software may not be improving the lives of patients. But the people who use it are. Making medicines, therapies, & treatments to save or improve the lives of patients is no small endeavor. Equally vital in this important mission is ensuring patient safety, which is why Pharmacovigilance (PV) is highly regulated by Health Authorities