3rd eRegulatory Submissions Summit

Start Date : July 9, 2019
End Date : July 10, 2019
Time : 8:00 am to5:00 pm

Email : mkeogh@questex.com

Location :
Sonesta Philadelphia Downtown Rittenhouse Square, 1800 Market Street, 19103, Philadelphia, United States



The Regulatory submissions landscape if ever-changing given the obligatory 2018 initiative to make CTD submissions electronic and the 2019 implementation period required for electronic submission of standardized study data. It is essential to ensure the quality and consistency of each document included in a submission to avoid complicating the regulatory submissions process when multiple team members get involved.


The 3rd eRegulatory Submissions Summit will cover changes made to the electronic submission processes and protocols for constructing strategies for IDMP, RIM, global and regulatory submissions. This summit will also address regulatory information management experiences and the standards for the identification of medicinal products and best practices for eCTD submission requirements.


Top Reasons to Attend:

- Understand the complete regulatory electronic submission process from beginning to end

- Assess the latest developments in ISO IDMP standards and understand the future of data in submissions

- Review the necessities for EDMS Implementation for eCTD system

- Plan improvements to submission processes and ensure communication between all steps in the regulatory submission life cycle

- Discuss time to market strategies and the role of submission management, regulatory project management, and agency interactions

- Gather the essential information needed to publish eCTD

- Explore global and regulatory eCTD management and requirements

Brochure https://go.evvnt.com/435355-3?pid=3506



Early BirdUSD 1895.0

StandardUSD 2095.0

OnsiteUSD 2195.0

Speakers: Michael Hellerstein Director, Regulatory Affairs and Quality Systems, GEOVAX, Sonja Justice Associate Director, Regulatory Operations, AMICUS THERAPEUTICS, Suzanne Libby Associate Manager, Regulatory Operations, AGIOS PHARMACEUTICALS, Lakshmi Ramkumar Medical Writing Department Head, BOSTON BIOMEDICAL, Deborah Satoh Head of CMC Submissions, TAKEDA , Marc Stern Director, Regulatory Processes, Operations and Publishing, EAGLE PHARMACEUTICALS, Robert Stumpo Director Global Regulatory Medical Writing, TEVA PHARMACEUTICALS

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Event Categories: Health & Nutrition.

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