and Clinical Safety
EU and Local QPPV services
As described in EU Directive 2001/83/EC, pharmaceutical companies need a qualified person for pharmacovigilance (QPPV). The QPPV must reside in the EU, must be continuously available, and must have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorisation holder.
PVpharm provides services for both EU QPPV and Local PV contact person in Spain. Pharmaceutical companies or CROs based outside Europe or outside Spain can benefit from this service either to fully outsource QPPV responsibilities or to cover both heavy work peaks and vacations.
PVpharm also provides a Deputy QPPV service. The Deputy QPPV will maintain close contact with your company’s QPPV and will be ready to take over when needed.
Local QPPV Spain
In addition to an EU QPPV, in Spain Marketing Authorisation Holders (MAHs) must have a permanent contact person for pharmacovigilance who is continuously available (Local PV contact), and MAHs must provide the Spanish Agency with the contact details for this person.
Responsibilities of local QPPV Spain
The local QPPV is responsible among other duties of:
Collect the information about adverse reactions happening in Spain and cooperate with regional pharmacovigilance centers to provide all available information.
Transmit any request from the Spanish Agency to the MAHs related to benefits and risks of a drug and to answer any information requested about the volume of sales.
Act as point of contact for safety reasons, as well as for actions taken in Spain concerning the provisions of the risk management plan.
Ensure the proper functioning of local pharmacovigilance activities and act as contact person for pharmacovigilance inspections in Spain.
Local literature search in databases and local scientific publications and translation into English on demand.
Local contact person for pharmacovigilance in EU countries
PVpharm can provide the Local contact person for pharmacovigilance in other EU countries (and also in several non-EU countries), in order to provide a global service in Pharmacovigilance. Contact us for more information
XEVMPD and IDMP
Since July 2012, MAHs in the EU are responsible of submitting and maintaining information on all EU-approved medicinal products and development substances of EU-based clinical trials to the XEVMPD (Article 57) database.
PVpharm provides an XEVMPD consultancy and data management services to help organizations manage their current XEVMPD data. We can create and maintain medicinal product information in the XEVMPD (Article 57) database.
Besides, this current XEVMPD format will begin an update to the International Standards Organization (ISO) Identification of Medicinal Products (IDMP) format in 2016.
The effects of the IDMP standards will be far-reaching, and full implementation, although beginning in 2016, will last several years. While this implementation presents pharmaceutical companies with many challenges, it also provides opportunities for better-prepared companies to meet and exceed this challenge. Preparedness is crucial not only to develop right and timely implementation strategies to avoid delays and complications resulting from this change, but also to fully leverage the power of this transformative change.
PVpharm also provides an XEVMPD/IDMP consultancy and data management service to help organizations prepare for IDMP implementation. We can help you maintain compliance in the face of an uncertain regulatory landscape.
How does it work:
First, an analysis phase is performed for the client in order to understand the client’s actual situation and current needs or deficiencies related to XEVMPD/IDMP implementation.
Then, an implementation roadmap is designed in order to timely plan the different activities or milestones that the client will need to go through regarding IDMP implementation.
Continuous intelligence coverage service is provided to the client, covering information from the main international standard organizations and regulatory decisions regarding IDMP.
Finally, the implementation phase will be agreed with the client in due course. PVpharm is in close collaboration with software and data management organizations, making possible a fast and professional implementation of IDMP for our clients.
PSUR / DSUR writing and report submission
PVpharm can help you with medical writing, especially for Pharmacovigilance. Our specialties include PSMFs, RMPs, and both periodic safety update reports (PSURs) and development safety update reports (DSURs). We interact closely with the MAH or affiliated Contract Organizations (CROs) to deliver top quality documents.
PVpharm currently specializes in PSURs and DSURs, also known as periodic benefit-risk evaluation reports (PBRERs), for numerous active pharmaceutical ingredients for medicinal products.
PVpharm can prepare EU GVP Module VII-compliant PSURs and DSURs, using both a review of scientific literature and company-supplied data. We can prepare ready-to-submit, customised PSURs to be submitted by the MAH or we can submit the PSUR to the new EU PSUR repository for you.
Our clients are MAHs and other CRO’s, we focus on close interaction in order to deliver top quality PSURs.
RMP and PSMF
In the EU, new Marketing Authorisation Applications (MAAs) legally require submission of the Risk Management Plan (RMP) describing the risk management system of the product. Besides, updates for the RMPs are expected for applications involving significant changes to an existing Marketing Authorisation or as a result of other situations, i.e. a request from a National Competent Authority, a result of a final study or conclusion of a PSUR.
At this particular point of time, GVP module V on Risk Management Systems is under public consultation at the EMA. The second revision of this GVP module is expected to contain significant changes that the MAHs should be aware of.
The Pharmacovigilance System Master File (PSMF) is a document maintained by the MAH describing the pharmacovigilance system for one or more of the MAH’s products. The PSMF may be requested by Competent Authorities at any time, and MAHs must be ready to provide it within 7 days of a request to maintain compliance. Failure to provide these documents, or providing incorrect documents, can trigger an inspection.
PVpharm can prepare and maintain PSMF documents that conform to EU Good Pharmacovigilance Practices (GVP) guidelines. We can also create and provide feedback on the RMPs as needed.
Signal Detection and Management
PVpharm provides a customizable signal detection and management process for Marketing Authorization Holders in the EU.
Based on your own needs, PVpharm will help you setting up the structure and procedures needed to comply with the legal guidance in Europe.
Your company may decide to outsource the full process to PVpharm. Signal detection is performed using Eudravigilance EVDAS, in compliance with the requirements of the new Good Pharmacovigilance Practices Module IX guidelines. Signal Validation includes Medical evaluation of the detected signals. PVpharm will help you manage any step of the Signal management process according to the GVP Module IX.
Please contact us if you would like to have more information about this service.
Medical Literature Monitoring
According to the GVP Module VI, the medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Marketing authorisation holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week.
The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties . In addition, marketing authorisation holders should have procedures in place to monitor scientific and medical publications in local journals in countries where medicinal products have a marketing authorisation, and to bring them to the attention of the company safety department as appropriate.
You can outsource your Medical Literature Monitoring to PVpharm.
PVpharm can help with several clinical safety activities, including:
- Legal representation in the EU
- Management of serious adverse events (SAEs) and SUSAR data entry and submissions via EVWeb to Eudravigilance and Competent Authorities
- Elaboration of Annual Safety Reports (DSUR: Development Safety Update Report)
- Protocol review
- Signal detection
- Organization and user registration and management in EudraVigilance / CTIS portal
- This includes creation of the Sponsor profile, Responsible Person and users in Eudravigilance / CTIS portal and maintenance of the profile
- CTIS submissions (see below)
- XEVMPD submissions
- Support during Marketing Authorization Application phase (MAA)
- Provision of other drug safety related services as requested by the client (i.e. review and input to documents and other PV activities)
PVpharm can provide support and training on the Clinical Trial Information System (CTIS).
The CTIS is a single entry point for submitting clinical trial information in the EU. The EMA will make information stored in CTIS publicly available.
The clinical trial application form and supporting dossier will cover all regulatory and ethics assessments from the Member States concerned. It will also include the public registration of the clinical trial and any subsequent updates.
The system will support the day-to-day business processes of Member States and sponsors throughout the life-cycle of a clinical trial in a user-friendly way.
It will provide regulatory oversight of clinical trials and tools for supervision and monitoring.
It will contain collaboration tools, workflow and document management capabilities, accessible via individual workspaces.