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Getting Smarter About Structured Content Management

In this webinar, guest presenter, Hans Van Bruggen will review definitions of structured content and structured content authoring and discuss the challenges that Life Sciences organizations face as the volume of documents (and data and information) required for regulatory compliance increase. He will offer strategies on how to reduce the complexity and cost of managing global content through effective content analyses, simplification of documents and lean authoring styles.

AMPLEXOR’s Agnes Cwienczek will provide insights into a structured, automated emphasis to document creation that can lead to operational cost savings and overall organization efficiencies.

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MEET THE SPEAKERS

Hans van Bruggen
Hans is Director and Senior Regulatory Affairs scientist at Qdossier and eCTDconsultancy, a Dutch company that advises pharmaceutical and biotech companies on reducing time-to-submission by implementing strategies, processes, and procedures related to scientific/strategic and operational aspects of drug development. He has an MSc in Pharmaceutical Medicine from the University of Surrey (UK) and has worked within, or for, the pharmaceutical industry for more than 30 years in global or European headquarters. He has gained a wealth of experience and a comprehensive view of what is needed to evaluate the benefit/risk ratio of drugs for patients and healthy volunteers. Hans has built up a solid reputation as a consultant for the pharmaceutical industry and is a popular and respected speaker at many regulatory congresses.

Agnes Cwienczek
Agnes has been in the position of Senior Life Sciences Consultant for AMPLEXOR since May 2017. Her primary 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.