Speakers/Presenters: | Topics to be Covered: |
- 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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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
Schedule:
Time: 8:00 am to 5:00 pm
| Contact Person: | Michael Keogh |
| Contact Email | mkeogh@questex.com |
| Organizer State/Province: (Outside US) | |
| Organizer Country | Data not provided |
| Structural makeup | Data not provided |
| Host Sponsor; Other Sponsors | ExL Events |
| Event Site/Venue | Sonesta Philadelphia Downtown Rittenhouse Square |
| Event sold out? | No |
| Multiple locations or dates? | No |
| Statistics available for most recent event held in: | NA |
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| Target Boundaries | International |
| Is Registration contact information the same as Organizer Contact above? | NA |
| Registration Contact: | |
| Registration E-Mail: | |
| Registration Phone: | |
| Registration Fax: | |
| Web Page | https://go.evvnt.com/435355-2?pid=5188 |
| Can one register for your CE on your web site? | NA |
| Can registration be made by snail (regular) mail? | NA |
| Online housing reservations: |
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| Do you have additional written or AV materials for sale? | NA |
| If so, are they available for non-attendees as well as those attending? | NA |
| Is full tuition necessary to ensure registration? | NA |
| Will there be shuttle service available? | NA |
| Additional notes: | Brochure https://go.evvnt.com/435355-3?pid=5188 |