COVID-19: Business continuity actions at PVpharm

Post published: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…

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System Madrid (25th-27th March)

Post published:January 31, 2020

PVpharm is pleased to inform that our CEO, Jose Alberto Ayala Ortiz, will be participating as an instructor in a hands-on training course on the ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU. The course will take place in Madrid from 25th to 27th of March and will provide the extensive information regarding EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS. This hands-on training course covers: In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR…

Merry Christmas from PVpharm

Merry Christmas and a Prosperous New Year!

Post published: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

Post published: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

Post published: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

Post published: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.

Signal Management in Pharmacovigilance 18-19 November Berlin

Post published:October 16, 2019

PVpharm is happy to inform that José Alberto Ayala Ortiz will be training a DIA course in Signal Management 18-19 November in Berlin. Looking for PV learning opportunities still in 2019? Join this Intermediate Course for professionals with 2-3 years of experience in PV or related functions and learn: The concepts of signal detection and signal management and how to apply them within the participants' functions, including the data mining techniques for large volume ADR data analysis, relevant EMA guidelines as well as a future outlook.Learn with: José OrtizQPPV, PVpharmSpain Download ProgrammeRegister Now PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.

EVWEB and XEVMPD Training in Amsterdam (16th-20th September)

Post published:July 9, 2019

From the 16th to the 20th September, José Alberto Ayala Ortiz will be participating as an instructor on the EVWEB and XEVMPD training courses provided by the European Medicines Agency (EMA) in Amsterdam. From the 16th to the 18th September, a hands-on Training Course using the EudraVigilance System will be provided. This training course covers:-Explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B (R3).-The use of EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3).-Reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI "Management and reporting of…

EVWEB and XEVMPD Basel (24th – 28th June)

Post published:July 9, 2019

From the 24th to the 26th June, the European Medicines Agency (EMA) provided an EVWEB training course in Basel, Switzerland. PVpharm's CEO, José Alberto Ayala Ortiz had the honor to participate as one of the instructors. The training focused mainly on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products. Practical exercises were also included on the training for a better understanding and put in practice the acquired knowledge. In the same location, from the 2th to the 28th June, EMA also provided a XEVMPD (eXtended EudraVigilance Medicinal Product Dictionary)…

EVWeb and XEVMPD Madrid (20th-24th May)

Post published:July 9, 2019

Our CEO, José Alberto Ayala Ortiz participated as an intructor in the EVWEB and XEVMPD training. The course was offered by The European Medicines Agency (EMA) and took place in Madrid from 20th to 24th May. The EVWEB hands-on training course "The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B (R3) format" was held from the 20th to the 22nd May. This training covered the functionalities of the new EudraVigilance web application (EVWEB) and it included practical examples for creating, sending and accessing individual case safety reports (ICSRs) in the new ISO/ICH…