Importance of a Local Person for Pharmacovigilance (LPPV), Local Safety Officer (LSO).
What is an LPPV?
In Europe, every Marketing Authorization Holder (MAH) must establish a pharmacovigilance system to meet the legal obligations for compliance of its products.
As part of that obligation MAHs must appoint an EU Qualified Person for Pharmacovigilance (QPPV) to establish and/or maintain that PV system.
In several European and other countries there is also a legal requirement for a Local Person for Pharmacovigilance (LPPV) at that country level, which is in addition to the QPPV.
Whilst the requirements and legal responsibilities of the EU QPPV role are specified in EU legislation, the LPPV role is subject to specific national legislation.
Global coverage with local expertise.
With a local PV partner network that extends to 150 countries, Arriello is able to offer an unrivaled blend of in-house resource and expertise, combined with local in-country staff who fully understand local regulations, keeping you compliant and minimizing risk wherever your products are.
This service includes, but is not limited to:
- ICSR intake and local level processing.
- Local submissions (Aggregate reports, RMPs, ICSRs, etc.).
- Compliance monitoring.
- aRMM implementation.
- Fulfilling local PV requirements in relevant procedures and systems.
- Providing PV/product-specific training.
- Health Authority inspections.
Our Local Person for Pharmacovigilance (LPPV) service.
Through our extensive LPPV network we have a comprehensive understanding of the PV requirements in markets around the world, and based on that wide experience, how to meet all your local PV requirements.
All our network partners are fully vetted and qualified through the rigorous risk-based vendor audit programme run by our internal vendor management team. Each partner operates under our own Quality Management System, ensuring we have full oversight and control over compliance monitoring.
We can provide either a Local Person for Pharmacovigilance (LPPV) service, or a Local Contact Person for Pharmacovigilance (LCPPV) service, where this is legally required.
Our Local Safety Officer (LSO) service.
Where an LPPV is not legally required, we can still provide the services of a Local Safety Officer (LSO), a growing role in PV worldwide.
The LSO role’s objective is primarily the same as that of an LPPV i.e., to have a dedicated, knowledgeable, and efficient technical service at the individual country/ territory level.
The exact mix of capabilities and requirements of the role vary depending on local PV regulations and the client/product needs, but whatever your LSO requirements, we can propose and deliver a faster, better, smarter solution to meet them.
New: EU-QPPV & Local PV Guide.
We’ve compiled answers to frequently asked questions regarding MAH pharmacovigilance and local PVs.
What our clients say about us.
You already had in place all the SOPs and processes needed for a PV system, but in our case, you were always open to work with parts of our system (some of our internal SOPs...) including some really special Cinfa requirements.
After evaluating several vendors to help us set up and manage our global literature screening process, we chose Arriello due to their professionalism and thorough understanding of global requirements.
I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.
As we have expanded services the business development team has been prompt and understanding of our needs and worked diligently to ensure flexible pricing models that fit our unique structure and budget. The project team is always eager to add on a new service and understand our requests, providing a seamless transition and effective set-up.
Selected PV Case Studies.
Selected PV Case Studies.
