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Dec 04, 2013 11:00 AM - Dec 04, 2013 12:30 PM

Online

Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options

Speakers

Mitchell  Seymour, PhD, RAC

Mitchell Seymour, PhD, RAC

Principal/Founder; Lead, Regulatory Operations, Biohaven Pharmaceuticals, United States

Dr. Seymour is Founder and CEO of R&D Advisors, LLC. He provides regulatory affairs services for industry and academia including regulatory strategy, regulatory intelligence, and regulatory due diligence, and operational assistance including FDA meeting preparation and engagement and regulatory writing and submissions. He has broad therapeutic area experience relevant to drugs, biologics, and devices. Dr. Seymour also has positions at the University of Michigan in their Medical School and in the College of Pharmacy. Through their Michigan Institute of Clinical and Health Research (MICHR), he serves as Regulatory Project Manager and Lead of Regulatory Operations.

Antoinette  Azevedo

Antoinette Azevedo

Co-Founder, RegDocs365, United States

Antoinette Azevedo founded e-SubmissionsSolutions.com to advise all sizes of life sciences companies on technology implementation to manage regulatory documents and publish electronic submissions. She has been dedicated to life sciences since 1994. She was principal consultant with CSC Life Sciences 1994-97, director of west coast operations for Liquent 1997-2000, and founded e-SubmissionsSolutions.com in 2000. She has controlling interest in Sage Submissions and is partner in RegDocs365.

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