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…

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

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 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.

Signal Management in Pharmacovigilance 18-19 November Berlin

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)

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)

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)

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…

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…

EVWeb training in Prague

EVWEB Prague 15th-17th May

April 25, 2019

José Alberto Ayala Ortiz, the CEO of PVpharm, will be participating as an instructor in the EVWEB training organized by the DIA association in Prague from the 15th till the 17th May. This training, "The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format", will involve the functionalities of the new EVWEB application, practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B (R3) format. For more information and registration, please visit DIA and EMA websites to find the full training programme. PVpharm is also organizing in-house trainings in pharmacovigilance for…

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…