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Bethesda North Marriott Hotel and Conference Center

2018 年 02 月 05 日 7:00 上午 - 2018 年 02 月 07 日 3:00 下午

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

Regulatory Submissions, Information, and Document Management Forum

Session 3: Other Regions Update

Session Chair(s)

Michiel  Stam

Michiel Stam

Management Consultant, MAIN5 Gmbh & Co. Kgaa, Germany

Receive updates about developments in other regions including Canada, European Union, and Japan. Hear agency and industry representatives speak about electronic submissions, development of new data standards, local implementation plans, and Health Authority IT strategies.

Speaker(s)

Vikesh  Srivastava

Vikesh Srivastava

Associate Director, Business Informatics Division, HPFB, Health Canada, Canada

Speaker

Mickel  Hedemand, MSC

Mickel Hedemand, MSC

Special Advisor, Medicines Licensing, Workflow, Danish Medicines Agency, Denmark

Speaker

Harv W Martens

Harv W Martens

Technical Expert for JPMA on ICH M2 and M8 Expert Working Groups, United States

Speaker

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