News
Orbit Implementation Best Practices
Ensure a successful rollout with an optimized approach
March 10, 2023
Risk Management
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
February 21, 2023
News
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
January 10, 2023
Risk Management
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
December 1, 2022
News
The Process and Tracking “It” in Orbit
A year in Orbit – 2022 recap of the past year and what to look forward to in the coming years.
November 10, 2022
PVA & SDEA
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
August 19, 2022
PVA & SDEA
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
June 28, 2022
Controlled & Restricted Distribution
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
April 18, 2022
Periodic Reporting
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
March 11, 2022
Signal Management
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,
July 13, 2021
