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Device, Diagnostic, and Biotech Submissions
Session Chair(s)
Susan Vintilla-Friedman
Senior Director, Regulatory Writing
United States
Preparations by medical writers and regulatory departments for the submission process need to become more collaborative than ever before, now that the most recent legislation includes electronic mandates and increased and earlier communications with FDA. FDASIA 2012 is landmark legislation that became effective on October 1, 2012 that reauthorized PDUFA and MDUFA and contains breakthrough mandates for electronic submissions to streamline the FDA review process. It institutes a process for bringing generic biologics to market and offers numerous critical provisions to reform FDA programs. These reforms include fostering greater interaction between drug/device sponsors and the FDA, and more engagement with patients including those with rare diseases. The impact to medical and scientific communicators working on device, diagnostic, and biotech submissions will be discussed from both the commercial and academic sponsor perspective.
Learning Objective : At the conclusion of this session, participants should be able to: - Identify recent FDA requirements for electronic submissions that are relevant to your organization - Define strategies for increased communication with FDA and other stakeholders during the submission proces - Discuss new tools and processes needed for successful electronic submissions
Speaker(s)
Faculty
Susan Vintilla-Friedman
United States
Senior Director, Regulatory Writing
Faculty
Antoinette Azevedo
RegDocs365, United States
Co-Founder
Faculty
Mitchell Seymour, PhD, RAC
Biohaven Pharmaceuticals, United States
Principal/Founder; Lead, Regulatory Operations
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