In contrast to other areas of regulatory information management, labelling continues to stand apart as a disconnected tangle of systems and processes which lack any real consistency across the global business. Over-reliance on manual tracking, checks and edits can lead to risk, delay and cost. Amplexor’s Agnes Cwienczek offers some pointers on how to put this right in a recent article featured in Pharma Technology Focus.
Agnes Cwienczek has been in the position of Senior Life Sciences Consultant for Amplexor since May 2017. In her role as Life Sciences Consultant, Agnes is part of the Product Management team. Her main responsibilities are the contribution to the development and enhancement of the Amplexor Life Sciences Suite, supervision of the Life Sciences Consultants as well as the provision of business process and data management expertise to Amplexor clients in Regulatory Information Management, Document Management, and Submission Management. Before joining Amplexor, Agnes worked at Merck KGaA in Global Regulatory and Quality Assurance, where she was acting System and Process Owner for all regulatory owned systems, providing global leadership for the management of submission documents, regulatory data and archiving within the Merck Biopharma organization. She was responsible for implementing and maintaining the regulatory applications and data management strategy and roadmap, and ensure business operation of applications under her responsibility, and to lead a global team of regulatory operations experts. Agnes received her master’s degree in Information Management from the University of Koblenz-Landau.