home > news > detailed info

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.

phone +41 61 225 51 51
email Kuechengasse 16, 4051 Basel, Switzerland
Print this page
Send to a friend
News and Press Releases

CPI to showcase results from BioStreamline project developing novel biotherapeutics

CPI, a UK-based technology innovation centre and a founding member of the High Value Manufacturing Catapult, announced today that it will host an event in Darlington, UK on 26 June 2019 to disseminate the results of the £11.2M BioStreamline project to optimise the development of novel therapeutics. During the event, the project partners — Lonza Biologics, UCB Celltech, Sphere Fluidics, Horizon Discovery Group plc (Horizon), Alcyomics Ltd and CPI — will showcase the results and discuss the potential impact on overcoming some of the most significant shortcomings of the biologics supply chain.
More info >>

White Papers

Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models


For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality. One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
More info >>

Industry Events

FlyPharma Europe

22-23 October 2019, Copenhagen, Denmark

The FlyPharma Conference Europe 2019 is aimed at forward-thinking individuals and businesses that are ready to uncover the potential in their pharma supply chain. The event offers an interactive platform to discuss current and future challenges within pharma and cargo, with topics including market trends, cold chain innovations, latest regulatory demands, security technology, and how to encourage collaboration between supply chain players. There will be plenty of networking opportunities, including a complimentary evening networking event, where delegates can meet and catch up with senior and executive pharma and cargo professionals – gaining strong, new industry contacts and building on existing ones.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement