Pharmacovigilance services for the Pharmaceutical Industry.

EVWEB training in Amsterdam December 2018

Amsterdam is the next place where the DIA is organizing an EVWeb training. The course will take place at the BCN Amsterdam Arena on December 10th to 12th. José Alberto Ayala Ortiz is participating as trainer for this course.

The EVWeb hands-on training  “The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam, The Netherlands” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.

Please find the link to the EVWeb course and the complete courses program available from the EMA website.

PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

Comments Off on EVWEB training in Amsterdam December 2018

EVWEB and XEVMPD training in London November 2018

The DIA is organizing an EVWeb and XEVMPD training course at EMA in London in June, respectively on the dates 12-14 and 15-16. José Alberto Ayala Ortiz is participating as trainer for these courses.

The EVWeb  hands-on training  “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI ‘Management and reporting of adverse reactions to medicinal products’ and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

The “eXtended EudraVigilance Medicinal Product Dictionary” training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

The course also includes instructions for sponsors of clinical trials on how to provide information on Investigational Medicinal Products (IMPs) in the medicinal product dictionary before completing the clinical trials application form.

Please find the link to the EVWeb course from the EMA website and the complete courses program available from DIA.

PVpharm is organizing in-house trainings for pharmaceutical companies and CROs, please contact us for further information.

Comments Off on EVWEB and XEVMPD training in London November 2018

PVpharm to participate at EUPV Congress in Milano

PEC – Pharma Education Center S.r.l. warmly invites PV professionals from all over the world to the “European Pharmacovigilance Congress – 2nd Edition” which will be held on November 29-30, 2018in Milan, Italy. The core of the 2nd European Pharmacovigilance congress are the significant changes and challenges due to the EUDRAVIGILANCE implementation.

PVpharm will be participating in the Congress.  José Ortiz, our experienced trainer, will present a session with focus on Pharmacovigilance Quality System and impacts from the new Eudravigilance requirements.

Others key speakers will give out updates about latest Inspection Trends in Pharmacovigilance, how is changing the Signal Detection process, which is the impact of new requirements on the PV process as well as deepen PV quality system and a lot more! In-depth analysis will be given on Patients Support Programmes (PSP) and engagement for the set up of appropriate risk management and risk minimization measures.

This 2 day Congress will offer in total 12 sessions of oral talks and keynotes presentations, including round-tables, networking lunch sittings, exhibit area to showcase new and emerging technologies.


WHY TO ATTEND

The European Pharmacovigilance Congress represents a great opportunity for professionals and stakeholders to meet targeted audience and fully interact with participants from the Pharma, Clinical and Regulatory community.
This European event is a unique opportunity for exhibitors and sponsors to engage with global industry partners!

For more information take a look at the Congress website: 

https://www.eupharmacovigilance.com/

REMEMBER!
PVpharm is always keeping up with the last changes in pharmacovigilance and organize trainings adapted to every necessity. Take a look to our training page for more information.

Comments Off on PVpharm to participate at EUPV Congress in Milano

Audit on Signal Detection at Perrigo

José Alberto Ayala Ortiz has been performing an audit dedicated exclusively on the Signal Detectionprocess at Perrigo. The audit was held at their main offices.

The Signal Detection process was reviewed during the two days, and opportunities for improvement were proposed to the team. The main objective was to to contribute to improving risk management, control, and governance processes. 

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. Please contact us to request more information about independent PV audits.

Comments Off on Audit on Signal Detection at Perrigo