Pharmacovigilance services for the Pharmaceutical Industry.

PV Training II Edition is here!

After the success of the first edition of the I Pharmacovigilance Training, PVpharm is organizing its Pharmacovigilance Training II Edition on the 9th and 10th of May 2019 in Madrid.
The course will cover different trending topics in PV; focusing on Audits, Inspections, the QPPV role and Eudravigilance and Signal Detection. We will also cover the new GDPR from the perspective of Pharmacovigilance!
Our speakers include:

  • Mariano Madurga (Ex-Head of Co-Ordination Unit of the Spanish Pharmacovigilance System. Spanish Medicines and Healthcare Products Agency)
  • Calin Lungu (Lead EV and XEVMPD trainer, expert pharmacovigilance auditor, PV QA consultant, CEO of DDCS)
  • Maite Vazquez (Partner Life Sciences DA Lawyers)
  • Albert García Rierola (EU-QPPV / Head of Pharmacovigilance at Grupo Ferrer Internacional)
  • José Alberto Ayala Ortiz (PVpharm CEO, EU-QPPV, PV consultant)

For more information and to download our training brochure, please click here.
You can also contact us for any further information, we will be glad to help you.

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We are in the press!

Last Sunday, 10th March 2019, the news diary “La Razón” published an article about PVpharm; where our CEO, José Alberto Ayala Ortiz, introduces our company, explains what pharmacovigilance is and how does PVpharm deal with different regulations.

You can follow us on Linkedin and learn more about us clicking here.

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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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