Pharmacovigilance Audits

April 8, 2020

EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems. PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements. Our approach is risk and process based, our objective is to improve your pharmacovigilance system in order to achieve excellence in quality. We can perform face-to-face or remote audits. Our audit team consist of a group of experts in pharmacovigilance with several years of experience. Please contact us for more information.

Remote working instructions at PVpharm

April 7, 2020

COVID-19:REMOTE WORKING INSTRUCTIONS AT PVPHARM Due to the Coronavirus outbreak, PVpharm decided that all employees should work from home. Only under special circumstances it would be allowed to come to the physical offices. We would like to share with the community our rules, our tips, so everyone can benefit of this learning. Please, stay safe at home, try to avoid going out. Protect yourself and the rest of the society. It is a matter of civil responsibility and public health. Follow the recommendations of the Government and the WHO. Remote working instructions at PVpharm 1 - Stay focussed and committed…

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…

COVID-19: Business continuity actions at PVpharm

March 14, 2020

Let's help everyone stop COVID-19! At PVpharm we adopted business continuity actions in order to save the health of the people working in PVpharm and provide continuation of our PV services to our dear customers. PVpharm is following the recommendations of the Spanish Health Authority, that is recommending to restrict movement of people due to the COVID-19 outbreak. PVpharm decided that all employees should work from home starting on Monday 16th March 2020. Only under special circumstances it would be allowed to come to the physical offices. No disruption in our services is expected from this situation. Our team will…

Merry Christmas from PVpharm

Merry Christmas and a Prosperous New Year!

December 20, 2019

Merry Christmas from PVpharm Dear all, on behalf of the PVpharm Team I would like to wish you a Merry Christmas and a Prosperous New Year!

PVpharm opens an office in Madrid

December 16, 2019

We are happy to announce that PVpharm is opening an office in Madrid. For all our partners and collaborators we are welcoming you at our new location! PVpharm S.L. Núñez de Balboa, 35 Esquina Goya 5º Oficina A4 – 28001 Madrid PVpharm new office in Madrid PVpharm new office in Madrid

PVpharm participates in Nordic PV Day

October 26, 2019

On Thursday 24th October 2019 PVpharm participated at the Nordic Pharmacovigilance Day conference in Copenhagen, Denmark. Jose Alberto Ayala Ortiz, PVpharm CEO, was talking about Signal Detection using EVDAS. It was very nice to meet with former colleagues from the Danish Medicines Agency! Jose Alberto Ayala OrtizDoris Irene StenverVibeke Nielsen PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.

PVpharm in PIPA conference 2019

October 26, 2019

On Wednesday 2nd - Thursday 3rd October 2019 PVpharm participated at the PIPA conference in Stratford Manor, near Birmingham. Jose Alberto Ayala Ortiz, PVpharm CEO, was talking about Signal Detection using EVDAS. José Alberto Ayala Ortiz presenting at the PIPA conference 2019 PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.

PVpharm Pharmacovigilance Training II edition review

July 9, 2019

On 9th and 10th May 2019, PVpharm provided a pharmacovigilance training in Madrid. We had the honour to have as trainers: Mariano Madruga: a well known professional with more than 30 years dedicated experience in pharmacovigilance, being an official of the Ministry of health/AEMPS and developing the pharmacovigilance Network in Spain.Calin Lungu: Dr. Lungu has worked more than 20 years in drug development, clinical research, pharmacovigilance and quality assurance. He has done more than 140 PV audits and trained more than 250 Eudravigilance and XEVMPD courses at the EMAAlbert García Rierola: The EU-Qualified person responsible for pharmacovigilance (QPPV) at Ferrer…

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…