José Ortiz to participate as a speaker in the DIA QPPV forum 2020

September 30, 2020

José Ortiz, PVpharm CEO will participate as a speaker in the next QPPV forum organized by DIA. You can find more information in the link: https://www.diaglobal.org/en/conference-listing/meetings/2020/10/global-forum-for-qualified-persons-for-pharmacovigilance-qppv About the QPPV forum: In a changing and expanding world, this is still the only forum designed for QPPVs by QPPVs, now in its 14th year and still going strong. The QPPV Forum focuses on international QPs’ role and gives a high-level approach to the discussed topics and continues to identify key trends requiring QPPV awareness, input and oversight. This year’s objectives are built on past successes and have been shaped by valuable feedback…

Vojtech Kvita from PVpharm participates as speaker in the Clinical Trial Regulation Information Day for CEE Countries

September 17, 2020

Vojtech Kvita from PVpharm participates as speaker in the Clinical Trial Regulation Information Day for CEE Countries. The Clinical Trial Regulation Information Day provides a forum to prepare stakeholders from Central and Eastern European Countries for the implementation and launch of the new EU Clinical Trial Regulation (536/2014) which will replace the European Clinical Trials Directive (2001/20/EC). The Information Day will focus on the differences between the present and new requirements for managing clinical trials in the face of forthcoming changes. It further aims to provide a platform for discussion about the compliance with the new Regulation and associated implementing acts in…

PHARMACOVIGILANCE TRAINING III Edition – Madrid 21-22 May 2020, Save the date! – UPDATE: postponed

March 20, 2020

PVpharm is organizing the III Edition of the PHARMACOVIGILANCE TRAINING, this year it will be held in Madrid. The training was originally scheduled for the 21-22 of May 2020, but it has been posponed due to COVID-19. We will publish the new dates very soon. The previous editions in 2018 and 2019 were really successful, so we continue with a similar format, giving the participants now the chance to send questions to the speakers in advance. This year again, we have the honour to count with very relevant and experienced Speakers that will share their PV knowledge with the participants: Doris…

PV Training II Edition is here!

March 20, 2019

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…

We are in the press!

March 14, 2019

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.

PVpharm provides Qualified Person for Pharmacovigilance Services (EU QPPV)

February 28, 2019

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…