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Pharmacovigilance: the reality of ICH-R3

The European Commission has decided to review the safety monitoring of drugs across the pharmacovigilance sector.

​August 12, 2015

Recorded figures by the European Union state that up to 197,000 deaths are caused by adverse drug reactions (ADR); resulting in a total cost to society of €79 billion. With such alarming figures, it's with little surprise that the European Commission decided to review the safety monitoring of drugs across the pharmacovigilance sector.

Step in the right direction

As a result, new legislation is due to be introduced to help reduce the number of ADRs. Using the EudraVigilance, Europe’s data processing network and management system for reporting suspected ADRs during the development of new drugs, data will be better collated to produce clearer reports.

By storing all-known information relating to ADRs on one database, robust assessments can help the industry to increase its transparency and better communicate to patients. However, with ever-changing regulatory requirements, many pharmaceutical companies will have to significantly increase their workforce to meet the manpower needed to consistently analyse and update the required information into EudraVigilance.

Facing large upgrade projects, companies must ensure their PV databases are ICH-R3 (R3) compliant to meet legal requirements. At present many companies are using either ARGUS 4 or ARGUS 7 databases, however a further upgrade will be necessary when the new legislation comes into affect 2016.

In an attempt to be one step ahead, some companies have already implemented ARGUS 8 database, in hope that data migration to R3 will be easier. Unfortunately this may not be the case, as a PV Systems Project Manager advised us, “To hire someone to purely upgrade an ARGUS 4 database to 7 may take up to four months. However, if companies choose to implement the upgrade on a part-time basis, say 4-8 hours per week and migrating 1,000 cases, the project could take up to two years.”

“I don’t think there will be a wide implementation of R3 immediately, as many companies will wait to see how it develops. But, closer to the 2016 deadline, companies will scramble to hire experts to complete the upgrade projects under tight timelines, before it becomes compulsory.”

There is nothing new about the growing skills gap across the pharmaceutical industry. However, the impending demand for PV Systems experts may outstrip demand and add further strain on a sector that is already experiencing high-level of skills shortages. As we move closer towards the new legislation going live, the industry could very well face a new recruitment crisis.

Being ahead of the game

To better prepare clients, medical recruitment agencies should be working closely with pharmaceutical companies to employ traditional and alternative hiring solutions. Of course the traditional route would be to place PV Systems specialists, but as these candidates are rare and often work on a contractual basis, a more alternative approach is needed to help bridge the skills gap.

As mediators, we’re connecting our network of PV Systems specialists with clients to run training workshops for current staff. Expanding staff’s skill sets, the workshops ensure individuals are fully prepared to shift their work patterns to meet R3 standards; regardless if the company’s current database is ARGUS, Aris Global or an independent. By doing so, our clients are taking proactive steps to better prepare their staff for the necessary changes and most importantly, they are updating their internal infrastructure to be immediately ready for use once legislation comes into force.

Posted over 8 years ago

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