Pharmacovigilance services for the Pharmaceutical Industry.

EVWEB and XEVMPD Training in Amsterdam (16th-20th September)

From the 16th to the 20th September, José Alberto Ayala Ortiz will be participating as an intructor 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 adverse reactions to medicinal products”
-How to comply with the EudraVigilance business rules and the EudraVigilance Gateway, including WebTrader.
-Instruction on using the ICSR download functionality for MAHs to access ICSRs.

On the other hand, a face-to-face training course on eXtended EudraVigilance Medicinal Product Dictionary is provided on the days 19th and 20th September.

This 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).

For more information and registration, please check EMA or DIA website.

PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.


Comments Off on EVWEB and XEVMPD Training in Amsterdam (16th-20th September)

EVWEB and XEVMPD Basel (24th – 28th June)

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) face-to-face training course.

The EMA has prepared this XEVMPD face-to-face training course to facilitate the practical implementation of the requirements including technical aspects and all related procedures on electronic submission of information on medicines by marketing authorisation holders in the European Union (EU) and European Economic Area (EEA) countries outside the EU.

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

For more information, check the EMA or DIA websites.

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

Comments Off on EVWEB and XEVMPD Basel (24th – 28th June)

EVWeb and XEVMPD Madrid (20th-24th May)

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 E2B (R3). It also includes 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.

On the other hand, The EMA aslo provided a XEVMPD “Extended EudraVigilance medicinal product dictionary” training. This training explained how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary.

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

Comments Off on EVWeb and XEVMPD Madrid (20th-24th May)

Meet us at Farmaforum!

PVpharm will participate as an exhibitor in the 6th edition of Farmaforum, one of the most important events of the Pharmaceutical Industry in Spain. The event will be held in Madrid at IFEMA (Pabellón 8-Feria de Madrid) on the 28th and 29th of March.

We are so excited and impatiently anticipating the day of the event. If you decide to visit us, we will be so happy to receive you at our stand, STAND C31, to provide you any kind of information regarding our company, services, careers, etc; or to just have a cup of coffee and share a nice talk.

To request an appointment, please contact us or visit us directly during the event. 
We will be waiting for you!

Comments Off on Meet us at Farmaforum!