Jan Kolouch from PVpharm participates as co-trainer in the Eudravigilance EVWeb training 12-16 October 2020

Post published:October 6, 2020

PVpharm is pleased to inform that Jan Kolouch, will be participating as an co-trainer in the Eudravigilance EVWeb training, 12-16 October 2020, 14:00 – 18:30 The online course 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 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 Implementation GuideThe use of the EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to practice examples for…

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…

PVpharm joins FAEEM

Post published:September 18, 2020

PVpharm recently joined FAEEM (Almeria Foundation for Business Excellence). On 18th September 2020, José Alberto Ayala Ortiz and Elena Marín Cassinello participated in the governing board meeting that formally accepted PVpharm into FAEEM structure. FAEEM was created in 2007 by the Commission for Business Excellence of the Chamber of Commerce of Almería. The Foundation chaired from its foundation until December 2019 by the businesswoman Pilar Martínez-Cosentino and from that date by Enrique de los Ríos of the UNICA GROUP company. FAEEM was born with the mission of carrying out and promoting training activities focused on the development of entrepreneurs and…

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

Post published: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…

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…

Faculty at Signal Management training by DIA

Post published:September 7, 2020

On 7-10 September 2020, José Ortiz, and Jan Kolouch from PVpharm provided the training faculty for the Signal Management training organized by DIA. This training provides knowledge over Signal Management to the participants, so they can apply the basic concepts and principles of signal detection in pharmacovigilance, from simple visualisation and tabulation methods to sophisticated data mining techniques. • Design the signal management process for institutions and companies of various sizes, portfolios and geographical presence, based on the possibilities and limitations of their data and resources • Understand key messages from the current European and US regulations on signal management,…

Pharmacovigilance Audits

Post published: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.

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

Post published: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…

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…

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.