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Bethesda North Marriott Hotel and Conference Center

Feb 11, 2019 8:30 AM - Feb 11, 2019 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Short Course 2: The Future of Regulatory Affairs

Instructors

Michiel  Stam

Michiel Stam

Director Regulatory Information Management, Qdossier - A Celegence Company, United Kingdom

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.

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.

Wim  Cypers, MPharm

Wim Cypers, MPharm

SVP Regulatory, ArisGlobal, United States

Wim Cypers has been with ArisGlobal for 23 years. In his current role, he heads all business unit operations for our regulatory domain, including overall product vision, strategy, implementation, and success of ArisGlobal’s Regulatory Solution Suite. Wim has long standing experience in converting business requirements into application functionality; and consistently showing industry thought leadership through speaking engagements at several industry events. He has applied his pharmacist training into a keen understanding of how to solve complex business issues. Before focusing exclusively on ArisGlobal’s Regulatory Business Unit, Wim managed the company’s strategy and product management function for both the safety and regulatory solutions.

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