Short Course: On the Road to an EU Filing: Getting Familiar with Critical EMA IT Systems

This is a Virtual Pre-Conference Short Course in conjunction with the Regulatory Submissions, Information, and Document Management Forum

Instructors

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  Michiel Stam

  • Director Regulatory Information Management
  • Qdossier - A Celegence Company, Netherlands

  Michiel has 15 years of experience in Regulatory Affairs and Information Management. He provides strategic direction and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions. His focus goes beyond compliance, Michiel specializes in unlocking the true value of an organization’s data – whilst taking advantage of initiatives such as XEVMPD, IDMP and SPOR. Through the alignment of people, cross-functional processes, and tools, he has enabled efficient and sustainable data quality for a wide range of customers.

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  Joanne Roza, MSc

  • Senior Regulatory Affairs Consultant
  • Qdossier, A Celegence company, Netherlands

  Joanne Roza works as a Senior Regulatory Affairs Consultant at Qdossier. She is involved in regulatory affairs consultancy and has also expertise in regulatory operations for big- and small-sized pharmaceutical companies. Joanne holds a bachelor degree in Health Sciences from Maastricht University and a master degree in Health Economics, Policy and Law from the Erasmus University in Rotterdam. She started her career at Qdossier in 2016 and has experience in regulatory operations and affairs projects. Joanne’s areas of expertise are: regulatory affairs (strategy and planning), preparation/creation and dispatch of electronic submission formats (e.g. US FDA, CA, EMA, CH), lean/structured authoring and the creation of baseline submissions.

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  Matthias Sijtstra

  • Senior Regulatory Data Specialist
  • Qdossier, A Celegence Company, Canada

  Matthias works as a Senior Data Management Specialist for Qdossier, a Celegence company. The focus of his work is Data Management, where he provides consultancy and subject matter expertise for implementation of Regulatory Information Management (RIM) solutions and compliance projects (e.g. IDMP/DADI). In these projects, he is looking to gain more for the client than just compliance, by engaging people, processes, and tools, he is working to improve the client's data quality. Additionally, Matthias has experience in software development and validation in a highly regulated environment.

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  Yusuf Azzeddine Leenen

  • Regulatory Operations Associate
  • Qdossier, Netherlands