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Join us in continuing our journey of advancing pharmacovigilance through innovation – in case intake, processing, reporting, signaling technologies, and more. We look forward to showcasing our latest capabilities, discussing key trends, and getting your expert feedback to drive the drug safety industry forward together.Register your interest today to attend the Safety Innovation Summit North America 2024, an in-person meeting at the Oracle campus in Reston, VA.
9:00am – 10:00am
Check-in and networking breakfast
10:00am – 10:30am
Oracle safety innovation: strategy and roadmap
11:30am – 12:15pm
Global regulatory trends
12:15pm – 1:15pm
Networking luncheon
1:15pm – 2:00pm
Real-world data for patient safety
2:00pm – 2:30pm
Oracle Cloud Infrastructure (OCI) for life sciences
2:30pm – 3:00pm
AI in safety: hot topics and evolving use cases
3:00pm – 3:30pm
Networking break
3:30pm – 4:15pm
Safety One platform architecture
4:15pm – 4:45pm
Pharmacovigilance assessments: overview & summary statistics
6:00pm – 9:00pm
Social evening and dinner
Networking breakfast
Customer presentation
10:30am – 11:00am
Newest Empirica updates
11:00am – 11:30am
Newest Safety One Intake updates
11:30am – 12:00pm
Newest Argus updates
12:00pm – 1:00pm
Networking lunch
1:00pm – 2:30pm
Argus user breakout
Empirica user breakout
Partner breakout
Argus user breakout report out
3:30pm – 4:00pm
Empirica user breakout report out
4:00pm – 4:30pm
Customer Q&A, key takeaways, and what’s next
Bruce Palsulich Vice President, Safety
Bruce has over 27 years of experience in the healthcare and life sciences industries. He currently oversees safety product strategy at Oracle Health Sciences, including the Argus, Safety One Intake, and Empirica software suites, and with a specific emphasis on leveraging observational and other big data sources for product and patient safety.Prior to joining Oracle, Bruce was one of the founders and served as Vice President of Relsys International, leading the development of Argus before serving as President of Timeln Inc. He later returned to Relsys as the Chief Innovation and Strategy Officer and then joined Oracle through the acquisition of Relsys.Bruce earned a Bachelor of Science in Information and Computer Science from the University of California, Irvine.
Una Kessi Product Management Director, Safety and Pharmacovigilance, Oracle Health Sciences
Una focuses on regulatory strategy, regulations thought leadership and roadmap, competitive intelligence updates, and collateral for the field. She is also responsible for products in the Oracle Safety One Platform, defining product requirements for E2B(R3), ICH and regional, IDMP, and medical devices. Una joined Oracle Health Sciences in 2011 as a Safety Manager within the Audit and Compliance team. Prior to that, she worked at Roche with a career spanning 16 years. She held various roles there including Drug Safety Manager (13 years) and Subject Matter Expert for the re-engineering of their drug safety processes and systems.
Sameer Thapar Global Head & Strategic Advisor
Dr. Sameer Thapar holds a doctorate of pharmacy (PharmD) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US and concurrently, holds an academic role of Professor, Drug Safety and Pharmacovigilance with a major US University. Dr. Thapar has over 20 years of experience in operations within the pharmaceutical, biotech, and CRO industries, with cross-functional experience in medical affairs, clinical operations, quality assurance, and subject matter expertise in pharmacovigilance operations and compliance. He has built global departments and defended in successful FDA, MHRA, and EMA health authority inspections. Dr. Thapar is an active advisor in US based life science industry conferences and participates as an invited speaker and panelist in global industry conferences.
Carrie Giannasi Vice President, Safety Product Management
Amit Agrawal Vice President, Software Development, Safety
Ashwani Bhat Sr. Applications Architect
Accommodation is not included, but we recommend that, if you intend to stay in Reston, you stay at the Hyatt Regency, which is very close to the Oracle campus, as well as the Reston Town Center.
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