How automation is changing regulatory affairs

The way pharma and regulators collaborate to bring safe new therapies to market is ripe for transformation but one major bottleneck slowing progress here is the onerous documentation process.The process of moving from paper to digital with the advent of electronic standards (eCTD) has improved certain aspects of the filing process - such as version control and the ability to copy chunks of data with greater ease – but this is only scratching the surface of what’s possible with automation. Pharma has only just begun to exploit the full potential of eCTD.A new paper from Reuters Events Pharma and DXC explores the progress of automation technologies to drive more efficient and error-free processes as well as faster time to insight and approval.  The paper, Digitizing regulatory affairs: The future of automation, examines how Pharma ’s regulatory functions are already streamlining their internal processes to prepare for broader automation, how the industry is piloting new workflows and how it is planning to exploit AI tools to drive further transformations.Near term, pharma can apply automation to routine processes that are typically offshored to service companies with rapid ROI, and it can realise quick wins with more content automation such as protocol summaries.Further out, there is enormous scope to reduce handoffs in the documentation creation process, the number of people involved, and the time taken as internal processes are aligned and automated.Less friction on t...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news