The Orbit Blog

PVA & SDEA
Mary Coleman

Recap: Modernizing your PVAs with Orbit

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

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Controlled & Restricted Distribution
Mary Coleman

RMP and REMS: The Most Stringent Risk Minimization Measures – Restricted Distribution

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

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Periodic Reporting
Mary Coleman

Helping organizations move away from reactive Aggregate Safety Reporting

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

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Signal Management
Katherine Long

When signal management is the answer to signal detection challenges

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,

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Risk Management
Kevin Fetterman

Proactive Compliance in the Current Global Risk Management Environment

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

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News
Matt Rost

Orbit 6 and Beyond with Matt Rost

Our latest release included over 250 new features and improvements. The biggest driving factor this past year – for version 6 – was streamlining the system for local safety officers.

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PVA & SDEA
Kevin Fetterman

Managing Compliance in Pharmacovigilance Partnerships

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

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Risk Management
Kevin Fetterman

Insights from Orbit Summit’s Risk Management Panel

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.

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News
Katherine Long

Orbit is Featured in PRA’s Pharmacovigilance Newsletter

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

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