Pharmacovigilance services for the Pharmaceutical Industry.

PVpharm provides Qualified Person for Pharmacovigilance Services (EU QPPV)

PVpharm provides EU Qualified Person for Pharmacovigilance (EU QPPV) and Deputy EU QPPV with large knowledge and experience of the industry. Besides, PVpharm has contact persons for pharmacovigilance in several EU countries

Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH’s PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with the legal requirements.
The EU QPPV has the following responsibilities regarding the medicinal products covered by the PV system:

  • Overview of medicinal product safety profiles and any visible safety concerns
  • Awareness of any conditions or obligations adopted as part of the MA and other loyalties
  • Awareness of risk minimisation measures

In the other hand, an EU QPPV must:

  • Act as a single point of contact for the European Medicines Agency (EMA) and EU Competent Authorities on a 24-hour basis, and the contact point of inspection
  • Ensure and verify that the pharmacovigilance system master file (PSMF) is constantly in place

The EU QPPV must have an adequate theoretical and practical knowledge for the performance of PV activities, reside in the European Economic Area (EEA) and be constantly at the disposal of the marketing authorization holder (MAH).
Why outsourcing your EU QPPV is important?
Outsourcing your Qualified Person for Pahrmacovigilance has many potential benefits:

  1. Lower costs and increased efficiency
  2. Reduces the number of resources to recruit, manage and train
  3. Converting fixed resource costs into variable
  4. Improved business model and flexibility
  5. Improving on-demand access to unique expertise, intellectual property, and multidisciplinary knowledge

The pharmaceutical industry expands in size and global reach, which makes it face new and complex challenges. Therefore, we are here to make it easier for you. Keep up with your product innovation, care about your technology advances and let all activities related to pharmacovigilance for us!
PVpharm can provide the EU QPPV expertise. Our EU QPPV is based in Spain, country of the EU.
PVpharm can also help you to improve on your PV system and ensure that it meets the requirements of the legislation by auditing your existing EU QPPV and PV system to identify any gap and advise on optimal arrangements.
PVpharm also provides Local Contact Persons of pharmacovigilance in several EU member states. The local contact person for pharmacovigilance are the primary contact persons for their local competent authority and work closely with the EU QPPV.
For more PVpharm services, please click here.
For further information, feel free to contact us.

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Meet us at Farmaforum!

PVpharm will participate as an exhibitor in the 6th edition of Farmaforum, one of the most important events of the Pharmaceutical Industry in Spain. The event will be held in Madrid at IFEMA (Pabellón 8-Feria de Madrid) on the 28th and 29th of March.

We are so excited and impatiently anticipating the day of the event. If you decide to visit us, we will be so happy to receive you at our stand, STAND C31, to provide you any kind of information regarding our company, services, careers, etc; or to just have a cup of coffee and share a nice talk.

To request an appointment, please contact us or visit us directly during the event. 
We will be waiting for you!

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EVWEB training in Amsterdam February 2019

The DIA is organizing an EVWEB training in which José Alberto Ayala Ortiz will participate as a trainer. The course will be taking place in Amsterdam, exactly at the BCN Amsterdam Arena from the 11th to the 13th February 2019.​SMLXL

 The hands-on training “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B (R·) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.
For more information and registration, please find the link to the EVWEB course and the complete courses program available on EMA website.PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

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