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Keynote Address Announced!
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Join DIA and Ashley Brown, Senior Submission Coordinator, Regulatory Operations, Accenture, for "A New Passion to Life: Experiencing the Impact of Regulatory Submissions," the featured keynote address at the Regulatory Submissions, Information, and Document Management Forum in North Bethesda, MD.
Diagnosed in 2018 with Stage 1 PR, ER, and HER2 positive breast cancer, Ashley began to think about the parallels between her many submissions and those that enabled her access to quality medications and devices during her treatment. She will share her first-hand experiences and the new way that she looks at the importance of her work in the lives of patients.
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Get Answers to Your Regulatory Questions
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This year's Forum features more opportunities to hear from regulatory officials during FDA sessions on Digital IND Safety Reporting, an Electronic Submissions/eCTD Panel, and an exclusive "Ask the Regulators" International Panel.
We're pleased to announce we'll be joined by:
- Ron Fitzmartin, PhD, MBA, Senior Information Advisor, Office of the Director, CBER, FDA
- Virginia Hussong, Chief, Data Standards Program, CBER, FDA
- Ethan Chen, MBA, Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA
- Meredith Chuk, MD, MHS, Acting Associate Director for Safety, OHOP, CDER, FDA
The FDA Plenary session will present topics such as:
- Data Standards and Key FDA Projects
- The SPL to Fast Healthcare Interoperability Resource (FHIR) Format Initiative
- The Study Data Technical Rejection Initiative
- Digital IND Safety Reporting
- The ICH M11 Clinical Electronic Structured Harmonized Protocol
Advance Rate Ending January 16.
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Content Preview Webinar
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Status Update on the Implementation of IDMP
ISO Identification of Medicinal Products (IDMP) is a vital piece in working towards a data-driven environment in which key stakeholders (industry, regulators, and patients) can benefit from high-quality and quick access to data.
Join us at 11:00AM ET on January 9 for an in-depth exploration of the status of ISO IDMP implementation in the EU. Stay up-to-date with the latest information and get your questions answered live!
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Presented by Remco Munnik, Associate Director, Iperion and Michiel Stam, Regulatory Information Scientist, Qdossier B.V./eCTDconsultancy B.V.
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Learn More with DIA
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As your partner in continuous learning, DIA provides complimentary digital downloads to spur thought, reflection, collaboration, and action.
In your Regulatory Affairs and Submissions Resource Kit, you'll find links to intriguing articles from the DIA Global Forum and our peer-reviewed journal, Therapeutic Innovation & Regulatory Science (TIRS), exclusive podcast interviews, session recordings from DIA events, and more. Check back often for new content!
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We look forward to seeing you in February!
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DIA | 800 Enterprise Road, Suite 200 | Horsham, Pennsylvania 19044-3595
T. +1.215.442.6100 or toll-free at +1.888.257.6457 | E. Americas@DIAglobal.org
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