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Clinical and Regulatory Operational Excellence Forum


Interview with programme committee member Hans van Bruggen, MSC, Senior Regulatory Affairs Consultant, eCTDconsultancy B.V., Netherlands

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment?

Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?

On one hand, industry, as well as authorities, have not yet adopted electronic ways of thinking. They mainly think in paper processes: documents are often reviewed several times using a document management system or through email. In contrast, regulatory data is often scattered over multiple databases and spreadsheets, and the data entry is hardly ever verified. This happens mainly because documents are perceived to be a narrative. Though this is true for the scientific evaluation and justification of claims, this is not true for the factual data, and the majority of regulatory information concerns factual data. Nowhere in the ICH guidelines is it specified that regulatory information must be narratives, but ‘old habits never die’. Will we have to wait until the next generation comes along or are we going to be able to adapt!?

On the other hand, we still have legal obligations to archive information at the sending and receiving parties. Why is the data stored in so many places? More storage places translates to a vicious cycle of more complexity in maintaining the data leading to a higher risk of inconsistencies. Blockchain would allow for a reliable single storage of data, where permissions are granted to view the data and run analyses, however, the blockchain principles have not yet been adopted as legal archival copies.

Simultaneously, we are witnessing a challenge between transparency and privacy. Both industry and agencies are requested to disclose more information in the public domain but, at the same time, the EU GDPR and other privacy laws prevent the sharing of personal data. In this sense, more legal guidance is needed to balance what can and cannot be used.

2. Which opportunities are emerging from the digital innovation we are witnessing in regulatory and clinical operations? Which processes have been or have the opportunity to be improved?

• The flow of information exchange between disciplines within and across organisations (e.g. change request roles into a submission request, content, assessment, judgment) becomes seamless with digitalisation. This includes auto-population of data and dossiers, and automated workflows to inform people about the availability of emerged information.
• The expedited decision making based on instant querying of a database (e.g. which products are involved when a warning letter is released?) or the triggering of alerts if certain thresholds have been exceeded (e.g. incidence of a certain adverse event) arose thanks to digital processes.
• Big data lakes and other information sources, obtained faster and more easily through digital processes, can be used to analyse these databases and extract adverse events to complete the benefit-risk evaluation of drugs. They can also be applied for repurposing established products and fine-tuning indications, warnings, and precautions. Eventually, this will result in higher response rates and satisfaction levels per therapy.

However, a downside from this is that some products might start being described as first line for smaller patient populations. While this might reduce costs to the health care systems, from a patient’s perspective, it might make them feel they are not being taken seriously.

3. Why should professionals involved with these topics attend the DIA eDM/OpEx Conference 2018?

The DIA eDM/OpEx Conference brings together experienced professionals from access these areas of innovation. We’re talking about proven success stories, but we’re also talking about failures and what learnings we can take from those to bring back to our company processes. The conference is structured to facilitate joint conversations where these emerging technologies can work for us all, as well as, a clinical and a regulatory specific track to tackle specific issues faced by those professionals. The DIA eDM Forum is a unique opportunity to become more aware of options available, and how they can be adopted and adapted to efficiently manage pharmaceutical assets to serve public health.

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