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Bethesda North Marriott Hotel and Conference Center

05 feb 2018 7:00 a.m. - 07 feb 2018 3:00 p.m.

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

Speaker

Vikesh Srivastava

Health Canada, Canada

Associate Director, Business Informatics Division, HPFB

Mickel  Hedemand, MSc

Speaker

Mickel Hedemand, MSc

Danish Medicines Agency, Denmark

Special Advisor, Medicines Licensing, Workflow

Harv W Martens

Speaker

Harv W Martens

United States

Technical Expert for JPMA on ICH M2 and M8 Expert Working Groups

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