Central & Local Outsourcing of Global Pharmacovigilance
Optimizing your global pharmacovigilance activities' cost, efficiency, and agility by relying on a trustworthy partner
The growing landscape of the pharmacovigilance industry and how to adapt to it
A growing number of pharmaceutical/medical device/cosmetic companies have changed their model for managing vigilance activities, forming strategic long-term partnerships or one-time contracts. These decisions are based on different factors such as:
- Global increase in requirement to report adverse events or medical inquiries
- Vigilance compliance has become more global, with increasing regulatory requirements worldwide emphasizing the importance of an enterprise-wide responsibility for compliance.
- Vigilance functions are challenged to optimize cost, efficiency, and balance between central and local activities or from insourcing and outsourcing approaches.
- The need for an agile model adaptative to the product portfolio evolution
In this context, PLG has developed a unique offering combining global and regional hubs with central and local support that covers the following categories.
Medical information
Our medical information (MI) services ensure that all medical inquiries, product complaints, or adverse event reports from patients, caregivers, and healthcare professionals are answered consistently and professionally. We offer accurate and timely information so medicinal products, medical devices, cosmetics, and nutrients can be used safely and effectively, promoting global best practices.
Qualified person for pharmacovigilance (QPPV) - Local safety officer (LSO)
PLG has a pool of qualified and experienced pharmacovigilance specialists available to assume legal responsibility for PV on behalf of clients. Each team member possesses the specific qualifications, language, and residency requirements needed to perform in those various roles, including providing EU QPPV, UK QPPV, LRPPV (local responsible person for PV), and LSO roles.
EU QPPV
The European Union QPPV is appointed by the marketing authorization holder (MAH) to establish and maintain the MAH’s pharmacovigilance system. That person is responsible for overseeing all relevant aspects of the PV system. The EU QPPV is nominated on a 24-hour basis to respond to competent authorities and the European Medicines Agency (EMA).
Local Safety Officer (LSO)
When required by legislation, MAHs must have an LSO. The role is variously and interchangeably called LRPPV, local contact person for PV (LCPPV), or local QPPV (LQPPV).
Individual case safety report (ICSR) management
PLG provides expertise and support for all case processing activities from various sources such as clinical trials (all phases), spontaneous (patient/consumer and HCP), literature, regulatory authority, and license partner cases, including the provision of a safety database and support setting up and maintaining authority portals.
PLG expertise includes drugs, medical devices, cosmetics, and dietary supplements to identify and evaluate adverse events (AE), provide medical assessment, follow up directly with sites/reporters, and perform applicable regulatory submissions.
Literature monitoring
Our literature search support is based on three main activities: global literature, local literature, and ad hoc searches. Global and local literature searches are performed to identify the adverse reactions and report them to the health authorities.
The local literature search is conducted as per local regulations. The global literature search is performed in PubMed/Medline and Embase to identify the adverse reactions and to report them to health authorities.
Aggregate report and risk management plan
Our team of experts can provide reports with overarching insight into the risk-benefit profile of a medicinal product:
Our experts ensure the timely submission of high-quality periodic benefit-risk evaluation reports (PBRERs), periodic safety update reports (PSURs), and periodic adverse drug experience reports (PADERs).
Addendum to clinical overview (ADCO) for renewals, Development safety update report (DSUR).
The PLG risk management team provides strategic advice, including drafting, reviewing, and finalizing risk management plans for different types of applications and products.
Signal management
Our signal team ensures the creation and review of signal management methodology per the client’s specific products, risk profile, and requirements.
The signal management process includes the following activities:
- Signal detection
- Signal validation
- Signal confirmation
- Signal analysis and prioritization
- Signal assessment and recommendation for action
How PLG's global pharmacovigilance solution can benefit the client:
Whether it’s a strategic long-term partnership you require or support for only a selection of activities, PLG can propose an adapted support. PLG’s expert can set up the new PV system entirely or help our clients streamline and improve their existing one. An experienced, qualified, and reliable QPPV/LRPPV/LSO team guarantees their MAH to have a customized, practical, and compliant pharmacovigilance system. In addition, you will benefit from:
- An E2E delivery model with central governance adapted to client needs
- An international footprint with a direct presence and capabilities in an extensive number of countries, adapting quickly to new geographies with customized service
- 100% qualified staff or qualified partner
- Our experience in local pharmacovigilance outsourcing program management
- Cost efficiencies
- Innovative tools and compliant databases that automate searches and data consolidation
PLG's experience in pharmacovigilance provides a solid foundation for you
PLG has supported our clients with vigilance activities for many years. We recognize the changing trends in the industry and the growing needs of our clients to meet these changes. We continue to broaden our scope to match these needs and encapsulate these services for a holistic approach to managing your local and global vigilance needs; we are also ever-evolving to bring you additional solutions to make our services more cost-effective and efficient.
Case Study: Optimizing local PV activities, improving the client's efficiency and agility
Objectives are determined based on the client’s needs
To successfully execute and accelerate the group strategy, the client’s global patient safety (GPS) team wanted to optimize the number of partners to support the client’s affiliates in performing local PV activities. The client’s objective was to ensure compliance and quality while gaining efficiency and agility to support their development.
The client wished to assess some potential partners for providing the services for all its affiliates by a combination of global or regional hubs in 4 regions: Europe – the Americas – Asia-Pacific (APAC) – Africa / Middle East / Eurasia (AME).
To maximize value and minimize cost in both routine activities and transitions/acquisitions, the client requested PLG to evaluate which partners best support according to the following:
- Direct presence and capabilities to manage the activities
- Compliance and quality
- Proactive ways of working and industry best practices
- Agility and flexibility for continuous improvement, process optimization, and scaling up for client development support
PLG’s proposed solution provides full coverage
Case management
- Mailbox monitoring
- Spontaneous and solicited cases, including local submissions
- Follow-up
- Local tracking system
- Reconciliations
Local literature
LRPPV
- LRPPV / PV representative
- Regulatory Intelligence
Ad-hoc activities
Project management and maintenance of the local quality system.
The added-value PLG advantage: hitting the bullseye
- Global presence with central and locally acting operating model based on three layers to ensure
- (i) the performance of local activities in compliance with local requirements,
- (ii) regional coordination, and
- (iii) global governance for process harmonization and client satisfaction monitoring.
- A transition and geographical roll-out in waves, based on a strong PLG readiness roadmap, adapted to the client’s requirements and priorities
- A flexible, scalable, and agile operating model