TOPRA Summit: Briefing now available
Posted on 22/08/2018

The advancement of disruptive digital technologies and enablers is causing the regulatory environment to undergo significant changes. Industry is looking at the growing potential of cloud-based solutions, which allow real-time repositories of data from sources such as wearables, as opposed to traditional static dossiers. 

TOPRA’s third annual Summit, held in London on 3 July 2018, provided a forum for senior professionals to hear the latest situation from business experts, discover how their peers are responding to the challenges and to put forward their opinions and proposed solutions. 

The progression and advancement in areas of healthcare research such as cell therapy, tissue engineering, 3D printing and multi-pronged approach biotechnology products are exciting to see, but the current regulatory framework is not keeping pace and this poses challenges for the profession, especially when there is little guidance available. Is the regulatory profession (both in industry and agency) prepared and informed enough to manage these seismic changes? Are the regulatory science discussions sufficiently current, given the rapid advancement of such disruptive technologies? Additionally, pharma is failing to keep up with the rapid digitalisation happening globally. What are the solutions so that it does not fall further behind?

Several key opinion leaders gave their reflections around the Summit’s theme. This was followed by break-out discussions of two groups, allowing participants the opportunity to develop ideas for how regulatory professionals can enhance their skills to support the different stakeholders to meet the challenges. Attendees also provided suggestions for how to incorporate new science and technologies into future legislation and guidance.

The full Summit briefing is available in the Papers area of TOPRA's website.