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2022 年 02 月 09 日 10:00 上午 - 2022 年 02 月 09 日 1:30 下午

Short Course: Structured Data: IDMP is Not the Goal

Instructors

Hans  van Bruggen, MSc

Hans van Bruggen, MSc

CSO, Qdossier, a Celegence Company, Netherlands

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Kate  Wilber

Kate Wilber

Director, Regulatory Information Management, Vertex Pharmaceuticals, United States

Kate has experience partnering with life science companies of all sizes to implement innovative software solutions that keep pace with regulatory, technology and industry rates of change. Kate has an extensive background in content management, submission compilation, and registration tracking. Her experience has given her unique insights into the problems and pressures facing life sciences companies as they look to get new treatments onto the global marketplace. With more than twenty years experience in electronic document management and global regulatory submissions, Kate is a credible subject expert skilled at helping companies find the most efficient way to leverage people, processes and technology in a changing landscape.

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