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Risk Management
Mary Coleman

Global Coordination, Local Implementation in Orbit: The Industry-Leading Solution for Managing and Tracking Risk Management Activities

Introduction When it comes to global risk management, pharmaceutical companies are in constant global/local tug-of-war – trying to achieve harmonization and consistency across efforts while managing the inherent diversity of local market requirements. Achieving this balance necessitates a comprehensive approach that transcends geographical boundaries and regulatory variations. Orbit by Feith Systems offers an advanced platform

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November 27, 2023
Risk Management
Mary Coleman

The Revolution of Technology in Pharma

Post-Conference takeaways from DIA Pharmacovigilance and Risk Management Strategies Conference 2023, Bethesda, MD Status Pharmacovigilance and drug safety have undergone significant changes in recent years due to technological advancements, increased regulatory scrutiny, and the growing demand for more efficient and effective monitoring of adverse events associated with pharmaceutical products. At the DIA Global Pharmacovigilance and

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February 21, 2023
Risk Management
Mary Coleman

Reaching Consensus on Core and Local Implementation

Companies are required to have and implement risk minimization measures, but there isn’t clear guidance on HOW to implement them beyond core documents like Risk Management Plans (RMPs). This article addresses the cross-functionalities of implementing risk minimization measures at multiple levels, and how Orbit can track variants and adaptations

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December 1, 2022
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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June 17, 2021
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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December 8, 2020
Risk Management
Katherine Long

New webinar announced: Globalization of Risk Management

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.

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February 13, 2020
Risk Management
Dan Feith

Tracking to the Nth degree – aRMM Distribution Metrics

Over the years, a common question heard in consultations: “How do we track our distribution metrics for our aRMM’s?“ Many organizations continue to rely on metric tracking spreadsheets, with a row for each metric and a column for each time period (month, quarter, year, decade, century, and so on). Now we all know at Orbit,

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August 2, 2019
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