Key take-aways from our June Webinar on modernizing your PVAs. Insights from presenters Katherine Long and Kevin Fetterman on streamlining your PV Agreement process from versioning through implementation with total oversight throughout. A robust Pharmacovigilance Agreement can protect both sides of a business partnership from uncertainty, communication gaps, and compliance risks. In fact, the GVP
Background The past two decades have seen a fundamental “swing of the pendulum” where regulatory agencies have increasingly scrutinized the patient safety risks associated with medications. This has led to a rising number of Risk Minimization commitments regulators are requiring from pharma and biotech companies. To handle tasks of tracking and managing Risk Management activities
The Challenge The regulatory demands of guidance, PV Legislation, and local Health Authority requests are ever-increasing. With that, so too is your global Aggregate Safety Reporting workload. The logistical challenge of responsibilities and safety commitments are time-consuming efforts that without consistent management, can be ineffective, costly, and even detrimental to patient safety. Complexity Teams must
The pharmacovigilance industry is locked in a race toward ever-more complicated signal detection algorithms. Cutting-edge technology like artificial intelligence, machine learning, and Big Data analytics is top-of-mind. While data science dominates the conversation, safety teams often overlook methods to optimize their approach to detection that do not require expensive data innovation programs. In this article,
In a recent Orbit webinar, I was joined by Dr. Simon Ingate of Axian Consulting to discuss the ever-increasing compliance challenges companies face to stay ahead of their regulatory commitments for risk management. The scrutiny on Pharma & Biotech companies shows no indications of waning — as Simon cited, in the first half of 2021
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
Drug Safety organizations are responsible for a variety of initiatives ranging from Health Authority required commitments to activities that keep operations running smoothly.