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European Biopharmaceutical Review

Manage Risk, Manage the Regulator

Risk management is the smart route to safety and well-aimed investment. In the increasingly competitive life sciences sector, Oliver Steck and Richard Petherick, at WCI Consulting Ltd, explain that picking up potential risks before they become a danger to the patient is imperative and has just been enforced by recent regulations

The traditional approach of pure compliance to regulations using a typically paperheavy system will probably keep you on the right side of the regulators – but, will it help you to improve your processes? The public demands a demonstrable increase in safety – no wonder the regulators are looking for a new approach! The traditional approach does not increase safety, nor does it deliver better or faster drug development, which ought to be one of the required outputs. Ultimately, the defect of the traditional approach is that, although it uses immense resources, it addresses the letter but not the spirit of regulations.

Shareholders are most likely to agree. Get caught putting profits before patient safety and nobody will trust you again. And trust is an issue that is right at the core of life sciences – once lost, trust is nearly impossible to recover.

FLEXIBILITY

The stakeholders seem to have a shared interest in a more flexible and sophisticated regulatory process. The industry must be ever aware of all its stakeholders. That includes patients, both those whose lives are being saved now and those yet to be saved. When everyone can see the point of a change, the law – patent, regulation – will follow. As a patient we want remedies that are effective, free of side effects, cheap and simple to use. The more serious our illness, the more important effectiveness becomes. The new, outcome-focused approach – where you are accountable for your serious adverse events (SAEs) whether technically compliant or not – is welcome in principle, but it needs to be backed by a systematic methodology.

That methodology is, without question, risk management and the accompanying IT – the smarter route to fewer adverse events (AEs), safer drugs and well aimed investment. But it is easy to do it superficially, endangering public safety, and regulators fear life science companies will use it as a shortcut to compliance. What it requires as a regulation tool is involvement and understanding from professional-level regulators rather than administration-level bureaucrats.


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Oliver Steck is a Managing Consultant with WCI Consulting Ltd. Since joining the organisation three years ago, Oliver has helped life science clients optimise their processes with regards to content management, compliance-related issues and risk management. Oliver holds a degree in Medical Computer Science from the University of Heidelberg and the Polytechnic University Heilbronn.

Richard Petherick is a Senior Consultant with WCI Consulting Ltd. He has 10 years of experience working in the quality arena of the life science industry, both in manufacturing and corporate roles. Richard’s areas of expertise include regulatory compliance, risk management, project management and quality assurance.

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Oliver Steck
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Richard Petherick
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