Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV) Services

Ensure Your Pharmacovigilance (PV) System Meets European Regulatory Requirements

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The QPPV and LPPV roles are essential for ensuring compliance with European regulators and requirements. They are also absolutely critical to maintain the safety of products marketed in the EU. Assigning the correct EU QPPV can demand substantial time and resources, which is why more and more organizations outsource this role to well-practiced third parties. Learn about the significance of a QPPV and LPPV and how we strategically partner with you in order to solidify your safety program.  It would be our pleasure to conduct an exploratory call in which we will provide information on how our services can help you with your pharmacovigilance operations.

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Role of the EU QPPV

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Every Marketing Authorization Holder (MAH) in Europe has a responsibility to establish a robust pharmacovigilance (PV) system (including all activities contributing to the detection, assessment, understanding and communication of safety information, as well as risk management), act as a single point of contact for regulatory authorities on a 24-hour basis, act as a contact for PV inspections/audits, oversee the safety profile of the company’s marketed products and any developing safety concerns. We ensure that all Gemini Group’s QPPVs and Deputy QPPVs undergo a robust training program, share their wide range of experiences and best practices through an internal QPPV discussion and are kept up-to-date with key changes to EU PV legislation and standards. Our consultants are always ready to pinpoint the need for additional risk minimization measures, approve proposed risk minimization measures within the RMP, support the Regulatory department throughout communication with the appropriate authorities regarding coordination of additional risk minimization measures and the effectiveness assessment, where applicable. They will ensure that the risk minimization measures are implemented and their effectiveness is evaluated appropriately. When developing and successfully launching a PV system in Europe, the MAH must assign an EU Qualified Person for Pharmacovigilance (QPPV) to create and preserve the MAH’s PV system. In addition to the institution and oversight of the PV system, the QPPV also has several legislative duties.

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Responsibilities of the EU QPPV include:

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• Serve as the 24/7 point of contact for Competent Authorities

• Coordinate actions to stay compliant with local legislation

• Establish and maintain the MAH’s PV system

• Monitor the safety of the MAH’s drug products

• Conduct audits and inspections to ensure compliance with EU regulations

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Role of an LPPV

 

It is very important to note, that in the EEA and many parts of the world, local QPPVs, also known as National Persons Responsible for Pharmacovigilance (NPRPs) or local contact person, is mandatory by national law, either at the time a marketing authorisation application is submitted or from the moment a product receives its marketing authorization.  e.g., for Germany a Stufenplanbeauftragter is required. While the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation.

 

The requirements differ from country to country in the EEA region and the majority of local authorities will require a NPRP already at the stage of Registration Dossier submission or product approval, regardless of whether the product will be launched or not. In other cases, a NPRP will only be required when the product is launched in that particular country. It is essential to understand the various requirements country by country. Gemini Group has subject matter experts and offers an widespread network covering 100+ countries of experienced and up-to-the-minute trained NPRPs. Together with them, Gemini Group monitors the local regulatory requirements for NPRPs, therefore we have a thorough understanding of the various needs in each country.

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Some QPPVs may have their own network of LPPVs to help fulfill local requirements. As a global pharmacovigilance provider, Gemini Group can advise you about the different important requirements for EU QPPVs and LPPVs, to make sure that you have the right resources in place to fully comply with the regulations for your PV system in Europe.

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Get Expert Guidance Managing Legislation Requirements

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Gemini Group can support your organization through the provision of appropriately qualified and experienced QPPVs, LPPVs, and deputies, as well as help your PV team prepare for new legislation.

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Gemini Group’s subject matter experts can guide you about the different roles and responsibilities of the EU QPPVs and LPPVs and offer services that can acclimatize your business needs and ensure compliance with the pharmacovigilance legislation unique to each location. We have a team of local persons available to fulfill these positions and strengthen your country PV operations as your company grows. We would be delighted to schedule a call with you in order for you to learn more about our QPPV and LPPV services.

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