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.


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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.

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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.

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PVpharm Pharmacovigilance Training II edition review

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 EMA
  • Albert García Rierola: The EU-Qualified person responsible for pharmacovigilance (QPPV) at Ferrer International. He has experience in different areas such as regulatory affairs and price and reimbursement,
  • Maite Vázquez: economist and lawyer, with training in Biotechnology and Pharma Law. She is the secretary of the Board of the Spanish Biotechnology Association (ASEBIO) and legal advisor in the Pharma and Health group of the Bar Association of Madrid (ICAM) and she has been advising companies in pharma and bio industry in regulatory, contracts, corporate and compliance matters.
  • José Alberto Ayala Ortiz: Pharmacist with specialty in IT who has been working more than 16 years in Pharmacovigilance and Drug Safety in multiple places including the Danish Agency and also as a trainer for EVWEB and XEVMPD trainings at the EMA and other locations.

During this course, we focused on different aspects and areas such as how a PV department is organized, the role of the QPPV and how this function is audited, personal data protection issues in PV, latest updates in the use of EVDAS for signal detection, ICSRs, PSURs, etc.

The training was held in Madrid, at the emblematic Hotel Emperador. The course was held in English, and there were participants coming from several locations across Europe. We could enjoy a fantastic atmosphere during the training and we would like to thank the participants for their valuable and professional contribution to the training.

Just like in the 1st edition, after the training, an anonymous questionnaire was administered to the participants in order to assess their satisfaction and to improve our performance on the coming editions. We would like to highlight 2 questions form the reviews:

Question 1. This course was…

As we can see, most of the participants, around 88%, describe the course as “excellent” or “very good”.

Question 2: How likely would you recommend this course to a friend or colleague (from 0 “not likely at all” to 10 “extremely likely”.

Participants assess the possibility of recommending this course to a friend or colleague as 9 (mean of the total answers).

The results were quite positive and we are very delighted and thankful to everyone for their inputs. We are looking forward to the 3rd edition!

PVpharm team.

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EVWEB Prague 15th-17th May
EVWeb training in Prague

EVWEB Prague 15th-17th May

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 pharmaceutical companies and CROs, please contact us for further information.

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PV Training II Edition is here!

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 Lawyers)
  • Albert García Rierola (EU-QPPV / Head of Pharmacovigilance at Grupo Ferrer Internacional)
  • José Alberto Ayala Ortiz (PVpharm CEO, EU-QPPV, PV consultant)

For more information and to download our training brochure, please click here.
You can also contact us for any further information, we will be glad to help you.

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We are in the press!

Last Sunday, 10th March 2019, the news diary “La Razón” published an article about PVpharm; where our CEO, José Alberto Ayala Ortiz, introduces our company, explains what pharmacovigilance is and how does PVpharm deal with different regulations.

You can follow us on Linkedin and learn more about us clicking here.

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PVpharm provides Qualified Person for Pharmacovigilance Services (EU QPPV)

PVpharm provides EU Qualified Person for Pharmacovigilance (EU QPPV) and Deputy EU QPPV with large knowledge and experience of the industry. Besides, PVpharm has contact persons for pharmacovigilance in several EU countries

Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH’s PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with the legal requirements.
The EU QPPV has the following responsibilities regarding the medicinal products covered by the PV system:

  • Overview of medicinal product safety profiles and any visible safety concerns
  • Awareness of any conditions or obligations adopted as part of the MA and other loyalties
  • Awareness of risk minimisation measures

In the other hand, an EU QPPV must:

  • Act as a single point of contact for the European Medicines Agency (EMA) and EU Competent Authorities on a 24-hour basis, and the contact point of inspection
  • Ensure and verify that the pharmacovigilance system master file (PSMF) is constantly in place

The EU QPPV must have an adequate theoretical and practical knowledge for the performance of PV activities, reside in the European Economic Area (EEA) and be constantly at the disposal of the marketing authorization holder (MAH).
Why outsourcing your EU QPPV is important?
Outsourcing your Qualified Person for Pahrmacovigilance has many potential benefits:

  1. Lower costs and increased efficiency
  2. Reduces the number of resources to recruit, manage and train
  3. Converting fixed resource costs into variable
  4. Improved business model and flexibility
  5. Improving on-demand access to unique expertise, intellectual property, and multidisciplinary knowledge

The pharmaceutical industry expands in size and global reach, which makes it face new and complex challenges. Therefore, we are here to make it easier for you. Keep up with your product innovation, care about your technology advances and let all activities related to pharmacovigilance for us!
PVpharm can provide the EU QPPV expertise. Our EU QPPV is based in Spain, country of the EU.
PVpharm can also help you to improve on your PV system and ensure that it meets the requirements of the legislation by auditing your existing EU QPPV and PV system to identify any gap and advise on optimal arrangements.
PVpharm also provides Local Contact Persons of pharmacovigilance in several EU member states. The local contact person for pharmacovigilance are the primary contact persons for their local competent authority and work closely with the EU QPPV.
For more PVpharm services, please click here.
For further information, feel free to contact us.

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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.

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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.

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