The Orbit Blog

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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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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Katherine Long

PVRMS 2020: Thoughts on the January Schedule

It’s January, and that means we are gearing up for DIA’s Annual Pharmacovigilance and Risk Management Strategies Conference (PVRMS). We set aside time to review this year’s agenda, and we are looking forward to listening and learning as part of this growing community of drug safety professionals. If this is your first PVRMS conference, here

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Periodic Reporting
Richard Long

Build-vs-Buy: How implementing a pre-configured PV Tracking solution will get you there faster

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

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