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Challenge 1

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Managing internal and external material compliance

The biggest challenge growing pharmaceutical companies face is managing their internal and external material compliance. However, there are ways to address this.

Work on a strict permissions basis

Fundamentally, you must ensure you are only giving teams the right materials.

As materials have become increasingly digital, the risk of them being shared with the wrong person or saved long after they should be withdrawn has significantly increased (though it has to be an improvement on the piles of sales aid in the boot of an old company car!).

You need to ensure that you are providing materials in a way which only gives access to the relevant team or individuals at the times when they should have access.

Control access to materials

With materials which need an associated briefing, you need to ensure your team have read and understood requirements before they start using the new materials.

Traditionally, this means getting the team together in a physical location for training – which is expensive, time consuming and lacks flexibility, for example, if a new license indication is approved two weeks later. More often now, teams send the materials and briefing documents out via email and have to trust instructions are being followed or spend considerable time chasing responses.

This, of course, doesn’t remotely meet requirements for proving any sort of compliance.

So what should you do?

1. Ideally, you need to link briefing documents to materials and only unlock the material when your users have read and confirmed receipt and understanding of the brief

2. You should also create deadlines for when users have to confirm receipt and understanding of the briefing document and make ‘chasing up’ an automatic process

The biggest challenge growing pharmaceutical companies face is managing their internal and external material compliance. However, there are ways to address this.

Apply clear deadlines and expiry dates for materials

The flip side to getting the right materials into your teams’ hands, is making sure you stop them using it following approval expiry.

Every single piece of promotional or regulatory material comes with limited approval and you are legally required to ensure they are either reapproved or are no longer used once this date has passed.

This was a well-established problem with print materials which should have been solved by the advent of digital, but is now an even bigger issue as materials proliferate across email, personal computers and file sharing systems.

You need to manage your materials in a way which allows you to set an expiry date where the material will automatically be withdrawn from the user. The materials should only be accessible in the location you have decided – it’s no good if they’ve emailed themselves a copy which then sits on their home computer for the next 10 years.

Track access and make sure you have proof!

One of the biggest advantages of digital is that everything anyone does can be tracked. Take advantage of that fact, and ensure you are capturing this tracking data, hugely streamlining and improving the efficiency of your compliance process. If you want to be fully on top of any potential audit, make sure you report on the following areas:

  • The users with access to each material
  • Who has read and acknowledged briefing documents
    (before deadline)
  • Who has read and not understood a briefing document

A system that will automatically capture the time any action was taken, which will offer a comprehensive report for any auditing needs.

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