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11 November 2019
The leading science and technology company
Merck Healthcare KGaA has been awarded the renowned CPhl Pharma Award in the category “Regulatory Procedures and Compliance”.
Leadvise Reply, the management consultancy within the Reply Group, supported Merck in the award-winning project
Smart Assistants for Regulatory Affairs (SARA). The 16th CPhI Pharma Awards recognize the innovation and dedication of companies who are driving the pharmaceutical industry forward.
The Regulatory Affairs Operations Team in Merck’s Healthcare Division is facing a constant change in regulatory requirements – Merck supported by Leadvise Reply realized solutions using Process Mining, Robotic Process Automation (RPA) and Text Mining to enable the team to handle the challenges. The Regulatory Affairs Operations department is responsible applying for and maintaining regulatory approvals, identifying relevant legislative changes and ensuring regulatory requirements for product development. In practice, this means, above all, obtaining, merging, transforming and transferring information with regulatory authorities such as EMA (European Medicines Agency) or FDA (U.S. Food and Drug Administration).
The award-winning project analyzed existing processes and identified those that would benefit most from automation. On the basis of the information obtained, the processes were then improved and automated using software robots following an agile approach to allow for quick adaptation. Special for the project is the concept of Rapid Prototyping, using the outcome of process mining to make fact based unbiased decision making. The aim is to build a Smart assistant, that supports users with smart automation and relieve their bright talents from doing dull work, and speed up processes, on average Merck submits a document to one of the regulatory authorities worldwide for review every 15 minutes.
Thomas Hartmann, member of board of Reply, is pleased with the CPhl award: “The award is a recognition of the determination and innovative spirit that the Mercks' Regulatory Affairs Operations Team of the Healthcare Department has continued to demonstrate. Leadvise Reply had the honor to support Merck with their new approach leveraging cutting-edge technologies such as Process Mining and Robotic Process Automation.”