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Bethesda North Marriott Hotel and Conference Center

2018年2月05日 (月) 午前 8:30 - 2018年2月05日 (月) 午後 12:00

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

Course 2: Essentials for Compiling/Publishing Compliant Electronic Submissions (eCTDs)

Instructors

Jillian E. Carinci, MS

Jillian E. Carinci, MS

Senior Director, Head of Submission Sciences, Biogen, United States

Jillian Carinci is Sr. Director, Head of Submission Sciences group at Biogen. Jillian leads Biogen’s Global Delivery Managers and is responsible for overseeing global submissions, establishing processes, ensuring compliance, robust submission planning, tracking metrics, high quality submission delivery and process improvements. Jillian began her career at Octagon Research Solutions before transitioning to Accenture. During her tenure at Accenture Jillian partnered with sponsors to manage numerous regulatory submission projects, ensuring compliance with global regulatory requirements, delivering within scope, on time, and with the highest quality.

Daniel  Orfe, MS

Daniel Orfe, MS

President and CEO, Regulatory eSubmissions, LLC, United States

Dan is a Leadership professional with 20+ years experience in Regulatory Submission production. A subject matter expert for eCTD & EDMS solutions. A business process analyst for submission assembly and eCTD publishing. He’s been a key member of several industry/agency initiatives for electronic submission standardization & efficiency. Dan has presented or chaired sessions at DIA Annual Meeting & DIA RSIDM/EDM Conferences. He's a DIA RSIDM Conference Program committee member. Dan established/directed eCTD publishing groups at Merck & Co., Inc. & Datafarm Inc. (leading eCTD software & services provider). At Teva, Dan led a initiative to harmonize the publishing environment into a single tool set (EDMS, eCTD Publishing etc.).

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