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About PrimeVigilance Why PrimeVigilance? Executive Leadership Team Operational Leadership Team Our Mission, Core Values and Vision PrimeVigilance Corporate Social Responsibility Statement Download PrimeVigilance Brochure Download Ergomed Brochure

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Ergomed Group Sites

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Services

End-to-end services for high-quality safety and pharmacovigilance operations

Benefit-Risk Management

Case Processing

Safety Systems and Reporting

QPPV and PSMF

Local Contact Person for Pharmacovigilance

GVP Audits/Inspection Preparedness

Medical Information Services

Safety and Medical Writing

Literature Surveillance

Signal Management

Pharmacoepidemiology

Medical Monitoring

Clinical Trial Safety Committee Management

Safety Management Plan

Project Management

Services Homepage

Solutions

Technology-driven solutions integrated into the pharmacovigilance landscape

PVConsult™

Optimise your PV operations through monitoring and use of technology by our SMEs.

PVTransition™

Come to rescue of your PV systems during service provider modifications or technology switch.

PVBridge™

Help our long-standing clients to develop in-house pharmacovigilance capacity.

PVIntegrate™

Streamline your PV systems and processes during expansion.

PVExpert™

Strengthen your negotiations with regulators, HTAs and external stakeholders.

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Product Expertise

Product expertise which enables efficiencies in PV operations

Innovative/Brand Products

Support the development of PV plans and risk minimization measures pre- and post-marketing.

Generics, Hybrids, Biosimilars

Methodical management of challenging PV agreements, signal detection, audits schedules & conduct and training.

Vaccines

Comprehensive PV management of seasonal vaccines ICSRs and systems to enable seamless end-to-end operations.

Devices and Combination Products

Our experts can advise you on your vigilance system, post-market surveillance and safety reporting.

Pediatric Medicines

Support tailored PV research in pediatrics and draw lessons from risk minimization of ARs in adult population.

Medicines for Older People

We adjust your RMPs cognizant that co-morbidities or side effects - specific to older patients - will shape PV activities.

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Insights Hub

Latest Case Study

PrimeVigilance’s Effective Approach to New Region Expansion

Uncover how PrimeVigilance navigated the complexities of expanding Medical Information (MI) services into Japan, establishing a strong foundation in a new and challenging market.

Published: 7 November, 2024

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Webinars

Latest Webinar

The Regulatory Landscape of AI: The Current State and Future Trends

This session explores the critical role of regulatory compliance in AI development, deployment, and governance, highlighting strategies for balancing innovation with ethical and legal requirements. Join our expert speaker, Nikodem Latocha, as he provides actionable insights into navigating this dynamic landscape, ensuring your organization stays ahead of regulatory changes.

Published: 14 November, 2024

Duration: 40 Mins

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News and Events

News

Navigating the Latest Revisions in GVP: Key Updates on Module XVI and Risk Minimization Measures

Published 24 September 2024

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Events

DIA Global Pharmacovigilance and Risk Management Strategies Conference 2025

Published 30 December 2024

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13 October, 2017

EudraVigilance changes and their impact on MAHs

Insights Hub

The recent changes in EudraVigilance (EV) reporting requirements have introduced new considerations for Marketing Authorization Holders (MAHs), impacting compliance, reporting efficiency, and data management processes.

This session provides a comprehensive overview of these EudraVigilance updates and their direct implications for MAHs. Ivana will cover simplified EV reporting requirements, access levels, and the handling of non-serious cases, while also addressing the challenges associated with downloading and processing ICSRs, managing the workload increases, and maintaining timely updates to the XEVMPD.

This session also explores the E2B (R3) format’s unique demands, including conversions from E2B (R2) and the implications for safety databases, with pragmatic tips for efficient processing to meet GVP VI requirements. Ivana will conclude with a live Q&A session to answer audience questions and share practical insights from her extensive experience.

Key Takeaways Include:

Overview of simplified EudraVigilance reporting requirements for MAHs
Guidance on EV access levels, handling non-serious cases, and ICSR processing
Strategies for managing increased workload and timely XEVMPD updates
Insights into E2B (R3) format conversions and challenges in data management
Best practices for selecting the appropriate EVWEB registration status and managing SDEAs

Expert Speaker

Ivana Sutalo

Senior PV Project Manager and Deputy QPPV

Don’t miss this opportunity to gain valuable insights from an experienced PV professional on navigating EudraVigilance updates. PrimeVigilance and Pharmafocus are dedicated to helping you stay compliant and efficient in this evolving regulatory landscape. Watch the recording now to optimize your approach to EudraVigilance changes and their impact on your pharmacovigilance operations.