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 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…

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.

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…

PVpharm Pharmacovigilance Training II edition review

Post published: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!

Post published: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…