News and updates from workinorbit.https://www.workinorbit.com/en-ushttps://www.workinorbit.com/managing-armm-implementation-across-affiliate-networks-closing-the-visibility-gap/https://www.workinorbit.com/managing-armm-implementation-across-affiliate-networks-closing-the-visibility-gap/Across global biopharma organizations, additional Risk Minimisation Measures (aRMMs) represent some of the most compliance-critical obligations a pharmacovigilance team manages. And yet, for many orgaThu, 28 May 2026 12:35:04 GMThttps://www.workinorbit.com/orbit-team-contributes-to-new-publication-on-advancing-pharmacovigilance-practices/https://www.workinorbit.com/orbit-team-contributes-to-new-publication-on-advancing-pharmacovigilance-practices/We're proud to share that Orbit team members Kevin Fetterman and Christopher Long have co-authored a newly published article in Therapeutic Innovation & Regulatory Science.Tue, 01 Jul 2025 15:45:06 GMThttps://www.workinorbit.com/from-blind-spots-to-full-visibility-rethinking-oversight-in-psmf-management/https://www.workinorbit.com/from-blind-spots-to-full-visibility-rethinking-oversight-in-psmf-management/Why QPPVs and global PV leads need better analytics—and how to get them. For pharmacovigilance leaders, managing the Pharmacovigilance System Master File (PSMF) isn't just a documentation exercise—it's a regulatory responsibility.Thu, 22 May 2025 14:32:00 GMThttps://www.workinorbit.com/the-value-of-ai-in-drug-safety-empowering-global-teams-and-protecting-patients/https://www.workinorbit.com/the-value-of-ai-in-drug-safety-empowering-global-teams-and-protecting-patients/In the complex world of pharmaceutical drug safety, access to the right information at the right time can mean the difference between proactive risk management and missed signals.Tue, 08 Apr 2025 15:24:55 GMThttps://www.workinorbit.com/maximizing-consistency-the-power-of-a-benefit-risk-strategy-document-in-pharmaceutical-management/https://www.workinorbit.com/maximizing-consistency-the-power-of-a-benefit-risk-strategy-document-in-pharmaceutical-management/As pharmaceutical companies navigate the complex landscape of drug development, regulatory compliance, and patient safety, having a clear and comprehensive benefit-risk management strategy is essential.Tue, 11 Feb 2025 16:19:25 GMThttps://www.workinorbit.com/the-hidden-risks-of-noncompliance-why-insight-into-pharmacovigilance-agreement-responsibilities-matters/https://www.workinorbit.com/the-hidden-risks-of-noncompliance-why-insight-into-pharmacovigilance-agreement-responsibilities-matters/In the pharmaceutical industry, ensuring patient safety is non-negotiable. Pharmacovigilance Agreements (PVAs) play a critical role in defining responsibilities between partners for monitoring and reporting adverse drug events.Thu, 16 Jan 2025 15:30:55 GMThttps://www.workinorbit.com/the-importance-of-aggregate-safety-report-process-harmonization-in-pharmacovigilance-operations/https://www.workinorbit.com/the-importance-of-aggregate-safety-report-process-harmonization-in-pharmacovigilance-operations/Pharmacovigilance is a critical part of ensuring patient safety and regulatory compliance in the pharmaceutical industry. Among the many responsibilities involved in pharmacovigilance, the creation and submission of aggregate safety reports (ASRs) are essential for tracking a product's safety profile across different markets.Thu, 12 Dec 2024 16:41:00 GMThttps://www.workinorbit.com/the-future-of-signal-management-how-process-automation-is-shaping-the-pharmacovigilance-landscape/https://www.workinorbit.com/the-future-of-signal-management-how-process-automation-is-shaping-the-pharmacovigilance-landscape/Signal management is a fundamental aspect of pharmacovigilance, helping pharmaceutical companies identify potential safety concerns and take swift action to mitigate risks.Mon, 07 Oct 2024 16:33:00 GMThttps://www.workinorbit.com/risk-minimization-in-the-age-of-ai-preparing-for-the-future-of-patient-safety/https://www.workinorbit.com/risk-minimization-in-the-age-of-ai-preparing-for-the-future-of-patient-safety/Pharmacovigilance is rapidly evolving, driven by technological advancements that transform how pharmaceutical companies monitor, detect, and manage the risks associated with marketed products.Fri, 19 Jul 2024 15:40:00 GMThttps://www.workinorbit.com/implementing-pvao-recommendations-the-orbit-approach/https://www.workinorbit.com/implementing-pvao-recommendations-the-orbit-approach/Pharmacovigilance Agreements (PVAs) are essential tools in ensuring drug safety and compliance across partnerships in the pharmaceutical industry. However, the complexity of these agreements often leads to inefficiencies, lengthy negotiations, and compliance risks.Sat, 16 Mar 2024 15:14:00 GMThttps://www.workinorbit.com/introducing-orbit-cloud-a-right-sized-orbit-option-for-small-to-mid-size-pharma-biotech/https://www.workinorbit.com/introducing-orbit-cloud-a-right-sized-orbit-option-for-small-to-mid-size-pharma-biotech/Orbit Cloud introduces a game-changing solution for small to mid-size pharma and biotech firms, balancing efficiency with budget-friendly pay-per-user licensing.Wed, 07 Feb 2024 08:17:34 GMThttps://www.workinorbit.com/global-coordination-local-implementation-in-orbit-the-industry-leading-solution-for-managing-and-tracking-risk-management-activities/https://www.workinorbit.com/global-coordination-local-implementation-in-orbit-the-industry-leading-solution-for-managing-and-tracking-risk-management-activities/Explore how Orbit merges global risk management with local implementation, ensuring safety and compliance worldwide.Mon, 27 Nov 2023 22:55:33 GMThttps://www.workinorbit.com/orbit-versus-a-custom-built-solution/https://www.workinorbit.com/orbit-versus-a-custom-built-solution/Choosing the right tech solution can make or break a company's efficiency and compliance in Pharma and Biotech industries. See how a cost-effective alternative to custom solutions is possible in Orbit.Tue, 30 May 2023 16:30:09 GMThttps://www.workinorbit.com/risk-minimization-360-two-cutting-edge-technologies-that-re-shape-the-way-you-manage-your-risk/https://www.workinorbit.com/risk-minimization-360-two-cutting-edge-technologies-that-re-shape-the-way-you-manage-your-risk/Explore 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.Tue, 25 Apr 2023 13:09:53 GMThttps://www.workinorbit.com/from-reactive-to-proactive-the-evolution-of-aggregate-safety-reporting/https://www.workinorbit.com/from-reactive-to-proactive-the-evolution-of-aggregate-safety-reporting/The adoption of electronic reporting systems, increased collaboration between stakeholders, and changes in regulatory requirements have all contributed to this shift in proactive safety reporting.Thu, 30 Mar 2023 18:16:13 GMThttps://www.workinorbit.com/orbit-implementation-best-practices/https://www.workinorbit.com/orbit-implementation-best-practices/Unlock the full potential of your team's implementation with Orbit.Fri, 10 Mar 2023 15:14:36 GMThttps://www.workinorbit.com/the-revolution-of-technology-in-pharma/https://www.workinorbit.com/the-revolution-of-technology-in-pharma/Post-Conference takeaways from DIA Pharmacovigilance and Risk Management Strategies Conference 2023, Bethesda, MD.Tue, 21 Feb 2023 19:40:37 GMThttps://www.workinorbit.com/orbit-2023-kicking-off-the-new-year/https://www.workinorbit.com/orbit-2023-kicking-off-the-new-year/Celebrating a decade of innovation, our mission continues to empower global safety teams with advanced, purpose-built solutions, freeing them from the manual and fragmented processes of the past.Tue, 10 Jan 2023 17:22:40 GMThttps://www.workinorbit.com/reaching-consensus-on-core-and-local-implementation/https://www.workinorbit.com/reaching-consensus-on-core-and-local-implementation/Orbit streamlines risk management by harmonizing core strategies with localized needs, ensuring effective and consistent implementation across all levels.Thu, 01 Dec 2022 19:18:00 GMThttps://www.workinorbit.com/the-process-and-tracking-it-in-orbit/https://www.workinorbit.com/the-process-and-tracking-it-in-orbit/A year in Orbit 2022 - a recap of the past year and what to look forward to in the coming years.Thu, 10 Nov 2022 13:46:00 GMThttps://www.workinorbit.com/pva-checklist-five-phases/https://www.workinorbit.com/pva-checklist-five-phases/Unlocking the complexity of Pharmacovigilance Agreements through five essential phases.Fri, 19 Aug 2022 18:38:35 GMThttps://www.workinorbit.com/recap-modernizing-your-pvas-with-orbit/https://www.workinorbit.com/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.Tue, 28 Jun 2022 17:53:31 GMThttps://www.workinorbit.com/rmp-and-rems-controlled-restricted-distribution/https://www.workinorbit.com/rmp-and-rems-controlled-restricted-distribution/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.Mon, 18 Apr 2022 21:43:44 GMThttps://www.workinorbit.com/helping-organizations-move-away-from-reactive-aggregate-safety-reporting/https://www.workinorbit.com/helping-organizations-move-away-from-reactive-aggregate-safety-reporting/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.Fri, 11 Mar 2022 21:06:34 GMThttps://www.workinorbit.com/when-signal-management-is-the-answer-to-signal-detection-challenges/https://www.workinorbit.com/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 intelligenceTue, 13 Jul 2021 15:22:37 GMThttps://www.workinorbit.com/proactive-compliance-in-the-current-global-risk-management-environment/https://www.workinorbit.com/proactive-compliance-in-the-current-global-risk-management-environment/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.Thu, 17 Jun 2021 13:00:00 GMThttps://www.workinorbit.com/orbit-6-and-beyond-with-matt-rost/https://www.workinorbit.com/orbit-6-and-beyond-with-matt-rost/Our latest release included over 250 new features and improvements. The biggest driving factor this past year – for version 6 – was streamlining the system for local safety officers.Wed, 10 Mar 2021 21:09:00 GMThttps://www.workinorbit.com/managing-compliance-in-pharmacovigilance-partnerships/https://www.workinorbit.com/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.Tue, 19 Jan 2021 05:31:00 GMThttps://www.workinorbit.com/insights-from-orbit-summits-risk-management-panel/https://www.workinorbit.com/insights-from-orbit-summits-risk-management-panel/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.Tue, 08 Dec 2020 10:09:00 GMThttps://www.workinorbit.com/orbit-is-featured-in-pras-pharmacovigilance-newsletter/https://www.workinorbit.com/orbit-is-featured-in-pras-pharmacovigilance-newsletter/Read PRA Health Sciences' quarterly newsletter here: Pharmacovigilance Newsletter The Feith Systems and PRA Health Sciences partnership delivers efficient tracking solutions to PRA's clientele while supporting their pharmacovigilance services.Wed, 18 Nov 2020 19:40:02 GMThttps://www.workinorbit.com/task-management-the-key-to-tracking-distributed-work/https://www.workinorbit.com/task-management-the-key-to-tracking-distributed-work/Drug Safety organizations are responsible for a variety of initiatives ranging from Health Authority required commitments to activities that keep operations running smoothly.Tue, 01 Sep 2020 12:01:00 GMThttps://www.workinorbit.com/new-webinar-announced-meddra-query-strategies/https://www.workinorbit.com/new-webinar-announced-meddra-query-strategies/Safety Evaluations are central to Pharmacovigilance Sciences. Demonstrating consistency in retrieving data for analysis can pose a challenge for large, global and matrix organizations.Tue, 28 Jul 2020 20:51:00 GMThttps://www.workinorbit.com/global-safety-in-practice-thoughts-on-dia-global-2020-schedule/https://www.workinorbit.com/global-safety-in-practice-thoughts-on-dia-global-2020-schedule/DIA Global has been moved to a virtual platform this year, for the first time ever, due to the COVID-19 pandemic. The DIA Annual Global Meeting is scheduled to begin this weekend, with content streaming Sunday, June 14, through Thursday, June 18.Wed, 10 Jun 2020 21:11:25 GMThttps://www.workinorbit.com/the-proactive-pva-imperative/https://www.workinorbit.com/the-proactive-pva-imperative/The successful handling of PVA obligations is a critical but often overlooked consideration.Mon, 25 May 2020 19:31:00 GMThttps://www.workinorbit.com/structured-data-collection-the-next-step-in-risk-minimization-tracking/https://www.workinorbit.com/structured-data-collection-the-next-step-in-risk-minimization-tracking/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.Wed, 29 Apr 2020 10:08:00 GMThttps://www.workinorbit.com/prudentia-feith-announce-medcodr-orbit-integration/https://www.workinorbit.com/prudentia-feith-announce-medcodr-orbit-integration/The new integration will support Patient Safety organizations as they define their safety data evaluation strategiesThu, 09 Apr 2020 19:49:39 GMThttps://www.workinorbit.com/webinar-globalization-of-risk-management/https://www.workinorbit.com/webinar-globalization-of-risk-management/Dan Feith of Orbit recently co-presented a webinar with Carla Perdun Barrett of PRA Health Sciences. The webinar recording is available here.Thu, 13 Feb 2020 22:59:00 GMThttps://www.workinorbit.com/risk-based-mhra-inspections-and-a-possible-end-in-sight-for-standalone-signal-detection-in-eudravigilance/https://www.workinorbit.com/risk-based-mhra-inspections-and-a-possible-end-in-sight-for-standalone-signal-detection-in-eudravigilance/Takeaways from the PV & Risk Management Strategies meetingTue, 04 Feb 2020 02:59:40 GMThttps://www.workinorbit.com/pvrms-2020-schedule/https://www.workinorbit.com/pvrms-2020-schedule/It's January, and that means we are gearing up for DIA's Annual Pharmacovigilance and Risk Management Strategies Conference (PVRMS).Thu, 16 Jan 2020 22:23:25 GMThttps://www.workinorbit.com/is-your-safety-team-ready-for-2020/https://www.workinorbit.com/is-your-safety-team-ready-for-2020/Risk and Safety in the new decade will be all about scaling your processes for the long-term.Tue, 07 Jan 2020 20:43:00 GMThttps://www.workinorbit.com/the-orbit-summit-2019/https://www.workinorbit.com/the-orbit-summit-2019/Top subjects at Orbit Summit 2019 Orbit customers have two things in common—a dedication to improving patient safety processes and the vision to do it with a great software platform.Tue, 15 Oct 2019 01:03:56 GMThttps://www.workinorbit.com/tracking-to-the-nth-degree-armm-distribution-metrics/https://www.workinorbit.com/tracking-to-the-nth-degree-armm-distribution-metrics/Over the years, a common question heard in consultations: "How do we track our distribution metrics for our aRMM's?"Fri, 02 Aug 2019 19:14:50 GMThttps://www.workinorbit.com/from-michelles-desk-fantastic-dia-global-2019-conference-last-week/https://www.workinorbit.com/from-michelles-desk-fantastic-dia-global-2019-conference-last-week/Reflecting back on the busy week with the Feith Team reaffirmed how valuable Orbit software is in solving the ongoing challenges in tracking Pharma's complex procedural activities.Thu, 27 Jun 2019 18:32:50 GMThttps://www.workinorbit.com/from-michelles-desk-improving-patient-lives/https://www.workinorbit.com/from-michelles-desk-improving-patient-lives/Our software may not be improving the lives of patients. But the people who use it are. Making medicines, therapies, & treatments to save or improve the lives of patients is no small endeavor.Fri, 21 Jun 2019 23:00:00 GMThttps://www.workinorbit.com/ae-intake-filling-outlooks-very-big-shoes/https://www.workinorbit.com/ae-intake-filling-outlooks-very-big-shoes/Email intake software for Adverse Events has big shoes to fill. It's replacing Outlook, one of the most mature products of all time. Those big shoes include capabilities like: – A no-training-necessary user interface – Simple Receiving, Archiving, and Sending of emailTue, 18 Jun 2019 20:44:13 GMThttps://www.workinorbit.com/buy-vs-build-how-implementing-a-validated-pv-tracking-solution-will-get-you-there-faster/https://www.workinorbit.com/buy-vs-build-how-implementing-a-validated-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.Fri, 01 Mar 2019 23:20:48 GMThttps://www.workinorbit.com/rmps-plan-locally-track-globally/https://www.workinorbit.com/rmps-plan-locally-track-globally/Pharmaceutical companies encounter challenges with tracking and sharing CORE, EU, and Local implementation of their Risk Management Plans (RMPs).Fri, 15 Feb 2019 02:55:37 GMThttps://www.workinorbit.com/lots-of-learning-dia/https://www.workinorbit.com/lots-of-learning-dia/Over the past few weeks, at DIA PVRMS in Washington DC and DIA Europe in Vienna, we had a lot of exciting and interesting conversations, and came back inspired.Wed, 13 Feb 2019 20:05:38 GMThttps://www.workinorbit.com/a-new-years-resolution-we-can-achieve-in-2019/https://www.workinorbit.com/a-new-years-resolution-we-can-achieve-in-2019/It's not how much you CAN track, it's how little you NEED to track At the beginning of each new project we work with our clients to understand their current tracking efforts: the data input to the tracker to be replaced (usually a spreadsheet), the users responsible for updating the tracker, and the compliance metricsMon, 03 Dec 2018 23:57:49 GMThttps://www.workinorbit.com/why-is-everyone-so-worried-about-their-additional-rmms/https://www.workinorbit.com/why-is-everyone-so-worried-about-their-additional-rmms/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.Tue, 18 Sep 2018 02:01:13 GMThttps://www.workinorbit.com/introducing-orbit-compliance-center-a-qa/https://www.workinorbit.com/introducing-orbit-compliance-center-a-qa/Feith introduces Orbit, a new platform that's flexible, validated and intuitive. Perfect for Tracking: Risk Management Plans, Commitments and Additional Risk Minimization Measures, Aggregate Report Generation and Submission, Safety Observations and Signals, Benefit Risk Evaluations, End-to-End Label Updates.Wed, 11 Apr 2018 22:54:27 GMThttps://www.workinorbit.com/happy-new-year-from-agilepv/https://www.workinorbit.com/happy-new-year-from-agilepv/Happy New Year to Patient Safety and Regulatory Professionals. You are responsible for massive amounts of data, and the stakes are high—yet every day you work to keep treatments safe and patients informed.Fri, 22 Dec 2017 00:03:48 GMThttps://www.workinorbit.com/patient-support-programs-eating-the-elephant/https://www.workinorbit.com/patient-support-programs-eating-the-elephant/Across the board, Pharmaceutical companies are looking to reduce the amount of effort they put into case processing. Case processing comprises a huge amount of manual effort in pharmacovigilance.Tue, 25 Jul 2017 23:06:19 GMThttps://www.workinorbit.com/risk-minimization-in-modules-v-xvi-show-dont-tell/https://www.workinorbit.com/risk-minimization-in-modules-v-xvi-show-dont-tell/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.Fri, 07 Jul 2017 23:12:26 GMThttps://www.workinorbit.com/tracking-your-signals-in-evdas/https://www.workinorbit.com/tracking-your-signals-in-evdas/So you found a potential safety signal in Eudravigilance EVDAS… now what? The EMA introduced and made available (to MAH's and national competent authorities) the Eudravigilance Data Analysis System (EVDAS).Mon, 13 Mar 2017 23:15:59 GMThttps://www.workinorbit.com/automation-in-safety-data-exchange-and-pv-agreements/https://www.workinorbit.com/automation-in-safety-data-exchange-and-pv-agreements/Keeping track of your various obligations and partnerships can be a chore. In this 20-minute webinar, the Orbit Team will go through three ways to simplify your PV Agreement tracking—from "quick wins" through end-to-end solutions.https://www.workinorbit.com/webinar-aggregate-reporting-with-orbit-2/https://www.workinorbit.com/webinar-aggregate-reporting-with-orbit-2/WEBINAR Aggregate Safety Reporting How to reduce global complexity with Orbit On-demand skip to registration Over the last few years, RIMS and Document Managementhttps://www.workinorbit.com/webinar-meddra-query-strategies/https://www.workinorbit.com/webinar-meddra-query-strategies/WEBINAR MedDRA Query Strategies Safety Evaluations are central to Pharmacovigilance Sciences. Demonstrating consistency in retrieving data for analysis can pose