The Orbit Blog

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

Read More »
News
Mary Coleman

Orbit 2023 – Kicking Off the New Year

A Decade In the Making As we celebrate our 10-year anniversary as a Software Solutions Provider for Pharma and Biotech companies, we at Orbit are grateful and excited to reflect on our approach to helping some of the world’s most advanced companies manage their safety-related needs. The Orbit platform was built on Feith’sSuite of Core

Read More »
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

Read More »
PVA & SDEA
Mary Coleman

PVA Checklist – Five Phases

Importance of a PVA A Pharmacovigilance Agreement’s importance boils down to the shared activities between two or more parties, which is defined in this legal document between the Marketing Authorization Holder (MAH) and a third party. The purpose of the agreement is for the MAH to access all the relevant information relating to PV activities

Read More »
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

Read More »
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

Read More »
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

Read More »
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,

Read More »