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Tuesday, June 29 • 12:30pm - 1:15pm
#228 IT: Certara Synchrogenix Innovation Theater: Medical Writing and Submission Compilation Made Easy - Technology Solutions from Regulatory Experts

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Component Type: Session
Level: Intermediate

There are significant benefits to using technology in the regulatory space from content creation through submission publishing. In this presentation, Synchrogenix regulatory experts will demonstrate the timesaving benefits of technologies that aid in the authoring of clinical study reports and patient narratives, as well as the review, validation and publishing of eCTD submissions. Highlighting specific past projects, we will share examples where we utilized these technologies for our clients.

Chair

Certara Synchrogenix

Speakers
avatar for Certara

Certara

United States
avatar for Gabriella Mangino

Gabriella Mangino

Product Manager, Certara Synchrogenix, United States
Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled... Read More →
avatar for Justin Savesky

Justin Savesky

Sr. Director, Regulatory Science Technology, Certara Synchrogenix, United States
Justin has been immersed in the technology field for regulatory science for over eight years. He leads Synchrogenix technology commercialization efforts, including product strategy and management.
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submission Leadership, Certara Synchrogenix, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

Tuesday June 29, 2021 12:30pm - 1:15pm EDT
TBD Virtual Event Horsham, PA 19044
  21: InnovationTheaters, Session