This article explores two cutting-edge platforms – Orbit and Axian One – that enable pharma and biotech companies to achieve a 360-degree view of their risk management activities.
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
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
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
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.
Drug Safety organizations are responsible for a variety of initiatives ranging from Health Authority required commitments to activities that keep operations running smoothly.
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.
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.
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,
Most Pharma companies rely on passive tools—such as spreadsheets and email—for tracking and managing their Risk Management Plans (RMPs) and Additional Risk Minimization Measures (ARMMs). However, passive tools are inefficient. So, what can Pharma companies do to scale? The answer is: utilize modern technology strategies for managing these processes. However, the first decision they should
