EVMPD and xEVMPD

EVMPD, XEVMPD and ISO IDMP

Providing you with a complete portfolio of solutions and access to unique software.

PDS is a leading provider of xEVMPD outsourced services, with thousands of successful submissions made on behalf of its clients since 2012.

In an increasingly competitive market place with significant new initiatives being introduced, such as ISO IDMP, Unique Device Identification (UDI) and greater safety restrictions for Cosmeceuticals, there is a growing trend within the medicines and healthcare industry for outsourcing specialist professional activities such as xEVMPD submissions. There are many benefits in doing so.

Considering outsourcing

When considering outsourcing xEVMPD, companies might feel that they are losing control over their products and related data. With a professional team supported by proven quality management processes, PDS can offer you a range of professional services that:

  • Are tailored to meet your specific needs
  • Ensure continuity of your internal processes
  • Maintain the highest quality standards combined with excellent team work.

As new challenges are presented to us, such as ISO IDMP (speculated to come into play at the end of 2017), PDS will work with you to help you overcome them and ultimately achieve compliance.

ISO IDMP is a global standard of reporting that will replace the incumbent xEVMPD in the EU, and SPL in the US. Its aim is to provide universal ID for drugs referenced in individual case safety reports (ICSRs).

Just as xEVMPD was the next step from EVMPD, IDMP is the successor of xEVMPD, and with it comes more complex requirements from the EMA in terms of the volume and granularity of the data required.

 

Transition from xEVMPD – How PDS can help

PDS will help you with the Gap Analysis by comparing the data from xEVMPD with the fields required moving forward, using the iterations released by the agency as a foundation for comparison.

PDS has a wealth of experience in both EVMPD and xEVMPD and is establishing ISO IDMP structures with built-in flexibility to accommodate any changes to the final specifications. This enables us to provide the expertise and solutions to ensure you can meet your obligations in medicinal information management.

Our professional team’s wealth of experience in Pharmacovigilance and Regulatory, makes PDS one of the leading outsourced service providers in this field.

 

Did your xEVMPD submission policy work?

As industry looks towards the transition from xEVMPD to IDMP, it is important to draw from previous experience. In this instance, MAHs will move to IDMP using a core of existing xEVMPD data as the nucleus and should learn from that experience to help prepare for what comes next.

Key considerations:

  • How did the 2012 move to mandatory data submission affect you?
  • Have your xEVMPD submissions met the EMA’s required standards?
  • Do you have an ongoing xEVMPD submission system that works for you?
  • Have you any concerns about the data you have already submitted?
  • Do you have any concerns about the additional data requirements for IDMP?
  • Are you concerned about the transition to ISO IDMP standards?

 

What you can expect from PDS

 

Our expertise and experience promise

Our xEVMPD expertise covers

  • Highly trained and vastly experienced staff
  • Up to date with the current regulations
  • Knowledge of regulatory processes and experience gained from broader client requirements
  • Delivery of quality individually tailored projects
  • Correction of data within EVWeb or xEVMPD software
  • Regulatory submissions via EVWeb or EudraVigilance Gateway
  • Licence maintenance documents
  • Pharmacovigilance system and process documents

Have a question? Just call +44 (0) 1476 512395 or email info@puredrugsafety.com

Glossary of Terms

EVMPD : EudraVigilance Medicinal Product Dictionary. EuduraVigilance is the European Medical Agency’s own form of pharmacovigilance system.

XEVMPD : Extended EudraVigilance Medicinal Product Dictionary. Since July 2012, every marketing authorisation holder (MAH) has been required to submit product data about all authorised medicinal products for human use to the XEVMPD. This became mandatory on 2nd July 2012. There are no exceptions.

EVWeb : EudraVigilance Tool

EMA : EuduraVigilance European Medicines Agency

IDMP : Identification of Medicinal Products

ICSR : Individual Case Safety Reports

HL7 : Health Level 7

SDO : Standards Development Organisation

ISO : International Organisation for Standards

CEN : European Committee for Standardisation

CDISC : Clinical Data Interchange Standards Consortium

IHTSDO : International Health Terminology SDO

Read our case study for xEVMPD

case study