xEVMPD case study

xEVMPD case study

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Mission Impossible? Article 57 compliance

The following xEVMPD case study highlights PDS’s ability to react and deliver to a client’s needs, in a situation where meeting a legal deadline was critical to the client’s business.

Background – a pressing requirement

When a major pharma company contacted PDS to help them in complying with their xEVMPD requirements, to say time was pressing is something of an understatement. With the mandatory submission deadline barely three months away and with the client having no visible solution in sight, this was a challenge of some magnitude.

Within the following three months, PDS’s team did everything – from importing, collating and verifying the client’s historical EVMPD data, before testing, processing and completing the mandatory insertions into xEVMPD. In addition, PDS created manageable processes for maintaining the client’s xEVMPD data and managing updates beyond the initial deadline.

The project was successfully completed within the three month timeframe with the client achieving full compliance. This is how it happened. . .

 A partnership approach

In early 2012, PDS formed a strategic partnership with a software vendor to deliver a xEVMPD solution to the pharmaceutical industry. At that time, the majority of pharmaceutical companies were asking the same fundamental two questions:

  • How do we meet our obligations under the EMA mandate?
  • How do we maintain ongoing compliance?

With the July 2012 deadline for compliance fast approaching, PDS took its offering to the DIA Exhibition in Copenhagen to tell pharmaceutical companies more…

Whilst there, our team was approached by representatives of a major pharma company (with headquarters in Europe) that had a portfolio comprising thousands of licences. With the legal deadline for submission of their licence data just three months away, they needed our help desperately.

At this point the client had not yet finalised their plans for handling xEVMPD submissions and their IT team was quoting a minimum timeframe of 12 months before the necessary software required to process and manage xEVMPD could be installed on their systems and validated. Clearly this would have taken them out of the EMA timeframe for initial submissions and made them non-compliant.

The team was approached by representatives of a major pharma company with headquarters in Europe. They needed help desperately. They had not yet finalised their plans for handling xEVMPD submissions and their IT team was quoting a timeframe of 12 months before the necessary software could be installed on their systems and validated. Clearly that would have taken them out of the EMA timeframe for initial submissions and made them non-compliant.

A practical solution

Meetings were held between April and May 2012 to discuss the practical considerations and the likely cost of outsourcing xEVMPD requirements to PDS over a period of three years. By early June, a complete solution had been mapped out to include.

  • The client’s own usage of the xEVMPD software (hosted at a UK Data Centre)
  • A bespoke piece of middleware (automated tool) to regularly import the company’s data into their new xEVMPD database
  • A team of Regulatory and Pharmacovigilance experts from PDS to collect and collate the cleint’s xEVMPD data and submit it to EMA in time for the July 2012 deadline
  • Ongoing work to carry out all updates and insertions into xEVMPD
  • Immediate notification of any regulation changes.

In summary the project comprised the planning, implementation, execution and reporting of xEVMPD submissions and ongoing maintenance beyond the initial 1 July 2012 mandatory deadline.

A successful outcome

Remarkably, the whole project was defined, agreed, set up, tested and validated, with the required data successfully submitted to EMA on behalf of the client – all within three months.

The outcome for the client was that they achieved regulatory compliance by the mandatory deadline, through a pain-free and highly cost effective outsourced solution. Additionally, they did not have to go through the process of trying to recruit anyone; nor did they have to research, buy, validate or learn how to use expensive new software.

Ultimately, what seemed impossible at the outset, was achieved through a combination of the team’s professional ‘can do’ approach, combined with its flexible and agile working practices, hands-on industry experience, dedication and of course, a lot of hard work.

The client was naturally delighted to have achieved compliance within the (extreme) timescales, brought about by PDS’s ability to work as a seamless extension to its in-house team, whilst adding value through a proactive and objective, common sense approach.