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
Pharmaceutical companies encounter challenges with tracking and sharing CORE, EU, and Local implementation of their Risk Management Plans (RMPs). Orbit makes tracking RMPs easy, while improving the planning, and sharing of all Core, EU, and Local RMP positions and related activities. There are five key challenges when tracking local initiatives. Here’s how Orbit resolves them:
Additional Risk Minimization Measures are invaluable for mitigating drug-related risks that are both severe and preventable. Having aRMMs in place often improves patient outcomes, yet aRMMs are notorious for creating challenges in operations and during inspections. So why are RM Teams struggling with additional RMMs? Managing aRMMs While Module XVI is an EMA regulation, it
Modules V and XVI are closely related regulations providing requirements for Risk Minimization Measures (RMMs) that you’ll need to account for in your RMPs. Where Module V covers your routine requirements, Module XVI adds the additional punch—you now need to track not just implementation, but also the effectiveness of your RMP. This can introduce complexity