Jan Kolouch from PVpharm to speak at conforum – pharmacovigilance seminar January 21, 2021

Post published:January 18, 2021

We are happy to inform that Jan Kolouch, Head of Pharmacovigilance and Clinical Safety at PVpharm, will be speaking at the pharmacovigilance seminar on January 21st , 2021. This seminar will be in Czech and organized virtually. Jan will be speaking together with other speakers, including representatives from national agency (SUKL). You can see the full information of this event at the link below: https://www.konferenceseminare.cz/farmakovigilance-aktualne-a-prehledne This online seminar will be conducted in the local language focusing on periodic safety reports and their evaluation, pharmacovigilance inspections and findings, pharmacovigilance reporting, signal management, EudraVigilance and Brexit. PVpharm also provides in-house trainings for pharmaceutical…

PVpharm selected as one of the top ten companies providing compliance services and transforming business

Post published:December 9, 2020

We are very glad to announce that PVpharm has been selected as one of the top ten companies providing compliance services and transforming business. The European edition of PharmaTech Outlook www.pharmatechoutlook.com has choosen us, a full article has been issued at the magazine website, it can be found here: https://compliance-europe.pharmatechoutlook.com/vendor/pvpharm-solving-the-riddle-of-pharmacovigilance-compliance--cid-1039-mid-107.html This recognition is coming in a very important moment for PVpharm. Thanks to the effort and good work of the team, PVpharm is growing and helping more companies. Also, PVpharm is initiating new strategic partnerships in order to support other companies in their Pharmacovigilance activities. Please read more about us…

QMS virtual course – 26-29 January 09.00-13.30 CEST

Post published:December 9, 2020

José Ortiz will be participating together with Brian Edwards in the faculty of the QMS training course organized by DIA. At the conclusion of this virtual live course, participants will be able to: • Describe how to design, develop, and manage a Quality System related to Pharmacovigilance System • Explain the components of the Pharmacovigilance Quality Manual • Describe the process for the development and maintenance of the Pharmacovigilance System Master File • Analyze how the Pharmacovigilance Quality System integrates with the Pharmacovigilance System • Discuss the development, maintenance, and quality oversight of Pharmacovigilance SOPs and Pharmacovigilance related documents, including…

Entrevista a José Alberto Ayala Ortiz – Visitadores Médicos Digitales (Spanish Video)

Post published:November 26, 2020

https://www.youtube.com/watch?v=fdfovftF_Zg&feature=youtu.be Today we share this interview in Spanish, where José Alberto Ayala Ortiz is invited in an interview on "Visitadores Médicos Digitales" by Miguel Ángel Martínez Barreira. Please watch the video here. PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

Jose Ortiz at the European Pharmacovigilance Congress 2020

Post published:November 19, 2020

We are delighted to announce that José Alberto Ayala Ortiz, PVpharm's CEO, will be participating in the European Pharmacovigilance Congress 2020 organized by the Pharma Education Center. You can find the link to the Congress here: https://www.pharmaeducationcenter.it/wp-content/uploads/2020/11/EUPV_Final_2020-1.pdf José will be participating in two round tables on the 27th of November:-Eudravigilance EVDAS updates-Local VS Global PV regulations Please see some screenshots of the sessions: PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

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

Post published: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…

QMS virtual course in September – NEW DATES – 22-25 September 09.00-13.00 CEST

Post published:September 16, 2020

José Ortiz will be participating together with Brian Edwards in the faculty of the QMS training course organized by DIA. At the conclusion of this virtual live course, participants will be able to: • Describe how to design, develop, and manage a Quality System related to Pharmacovigilance System • Explain the components of the Pharmacovigilance Quality Manual • Describe the process for the development and maintenance of the Pharmacovigilance System Master File • Analyze how the Pharmacovigilance Quality System integrates with the Pharmacovigilance System • Discuss the development, maintenance, and quality oversight of Pharmacovigilance SOPs and Pharmacovigilance related documents, including…

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)…