September 12-13, 2019
Please join Oracle Health Science strategists and solution experts in Utrecht on September 12-13 for our first European face-to-face meeting of the Oracle Safety Consortium, which replaces the Oracle Safety Focus Group meetings held in past years. Oracle Argus and Oracle Health Sciences Empirica product updates and demos, and pharmacovigilance hot topics will be discussed. We'll explore how Artificial Intelligence will revolutionise case processing in the coming years, the latest in drug safety regulations, and look at the benefits of moving to the cloud. The Consortium program will include break-out sessions for our Working Groups as well.
This meeting is for Oracle Safety customers, and registration is monitored. Attendance is free of charge, but space is limited, so we encourage you to register early to secure your place. Please see the “Accomodation” tab for details of local recommended hotels.
This meeting is held right after World Drug Safety Congress, taking place in close-by Amsterdam September 10-11. Please consider combining the two meetings to enhance your time in the Netherlands. Oracle staff will present at and attend WDSC, so it's a great opportunity to continue the conversation with us as well as getting a wider safety perspective.
We invite all delegates to join us for an evening networking event at the end of day one. Please indicate whether you plan to join us when you register.
Please contact the Safety Consortium Team should you have any questions regarding this meeting and register now to secure your place.
PLEASE NOTE: As registration is monitored, the location details will be provided upon registration confirmation.
Please take this opportunity to also join our regular Consortium web conference on the third Wednesday of each month.
Register now at
Empirica Signal & Topics 9.0
Safety One Intake Leveraging AI
Working Group Breakouts: Groups 1-4
Working Group Breakouts: Groups 5-8
Ask the Experts - Product & Configuration Q&A
Working Groups Prepare Final Report: Groups 1-4
Working Groups Prepare Final Report: Groups 5-8
Working Groups Present Final Reports
Prioritize Working Group Objectives/Initiatives
Senior Director, Safety Strategy, Oracle Health Sciences
Michael has been working in medicinal product safety for 24 years. He spent 13 years in the European PV headquarters of Fujisawa and Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle Health Sciences with the Relsys acquisition in 2009. As a member of the safety strategy team, he helps drive the product roadmap of the Oracle Safety Cloud and the Oracle IDMP Enterprise Foundation Suite.
Senior Director, Research and Data Science, Oracle Health Sciences
Rave Harpaz is Senior Director Research and Data Science at Oracle Health Sciences. Before joining Oracle, Rave was a Research Scientist at Stanford University, a post-doctoral fellow at Columbia University, and a quantitative risk modeling analyst at Merrill Lynch. Rave holds a PhD in Computer Science specializing in the area of machine learning.
Over the past ten years Rave has been conducting research on computational methods for pharmacovigilance, co-developed several methods for signal detection, and has authored over thirty peer reviewed publications in the area pharmacovigilance.
Senior Director, Enterprise Safety Cloud Strategy, Oracle Health Sciences
Robert is responsible for scaling the Oracle Safety Cloud SaaS offering to meet the needs of our large enterprise customers and leading the formation of the Oracle Safety Cloud Consortium. The consortium supports the migration to the Oracle Safety Cloud SaaS offering, but more importantly, this joint Oracle and customer consortium brings together our large enterprise customers to collaborate on best practices and our approach to responding to the ever-changing regulatory environment.
Robert's background includes his Chief Information Officer role at a Fortune 500 Company where he was a participant in an industry consortium, Big Four consulting, and his most recent experience founding a non-profit multi-national business development and trade alliance group. Robert holds an Honors Bachelor of Arts degree in Urban Development from the University of Western Ontario, Canada.
Product Management Director, Safety and Pharmacovigilance, Oracle Health Sciences
Una has been working as a Principal Product Strategy Manager at Oracle Health Sciences for 3 years. Her main focus is on Regulator Strategy, Safety and PV Regulations Thought Leadership and Roadmap, Competitive Intelligence updates and collateral for the field. She is also responsible for products in the Oracle Health Sciences Safety Suite 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.
Vice President, Product Strategy, Oracle Health Sciences
Bruce has over 25 years of experience in the healthcare and life sciences industries. He currently oversees safety product strategy at Oracle Health Sciences, including the Argus 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.
Rob van Manen
Master Principal Solutions Consultant, Oracle Health Sciences
Robbert van Manen is Master Principal Solutions Consultant at the Oracle Health Sciences Global Business Unit; he has considerable professional experience not only in the pharmaceutical industry, but also in the application of information technology in industrial scientific research and development in general and is currently responsible for quantitative safety signal detection and pharmacovigilance.
Mr. van Manen originally joined Oracle through the acquisition of Phase Forward, which he joined through the merger with Clinsoft Corporation in 2001. After the acquisition of Lincoln Technologies by Phase Forward in 2005 he focused primarily on quantitative safety signal detection and data mining as well as general pharmacovigilance. At Clinsoft and its earlier incarnations as Domain Pharma and BBN Software Products, Mr. van Manen was initially employed as Senior Technical Consultant in the UK in 1993. He later rejoined the company as Worldwide Technical Director after having held the position of Director of European Operations at NetForce, Inc. Before joining BBN, Mr. Van Manen was Head of the Clinical Data Systems department at Organon International. He also has nine years' experience as consultant for Computer Assisted Organic Synthesis and Computer Assisted Molecular Modeling (CAOS/CAMM) at Shell Netherlands in The Hague and the Royal Dutch Shell Research Laboratory in Amsterdam.
Mr. van Manen holds B.Sc. and M.Sc. degrees in Biochemistry and Bioinformatics from Leiden University in the Netherlands and has affiliations with several professional organizations including the Drug Information Association (DIA) and the Society for Clinical Data Management (SCDM) as well as current and past memberships of the CDISC XML Tech Committee, the CDISC Industry Advisory Board and the ISPE Industry Council.
Senior Product Strategy Manager, Oracle Health Sciences
Robert Weber is a Senior Product Strategy Manager in the Oracle Heath Sciences. His responsibilities include the Oracle Health Sciences Empirica Signal, Topics and Inspections products in the Oracle Health Sciences Safety Suite. Robert works with regulatory agencies and key industry clients to provide direction and manage priorities for the Oracle Safety products, define areas for enhancements and identify new solution opportunities.
Robert Weber is a qualified physician with practice background in neurology. He has worked since 1995 in the area of drug development, clinical research and pharmacovigilance. Earlier positions included Senior Manager and Principal Consultant at PAREXEL International, a contract research organisation, in Berlin and London; Senior Project Manager at DocCheck Medical Services in Cologne; and Principle Consultant at Phase Forward's Lincoln Safety Group.
The meeting takes place in Utrecht, Netherlands, and venue details will be provided upon confirmation of registration.
Recommended local hotels include:Carlton President Utrecht
Utrecht 3542 DXNote: The Carlton offers a courtesy bus service to the nearby meeting venueNH Utrecht
Utrecht 3521 ARPark Plaza Utrecht
Utrecht 3531 BLGrand Hotel Karel V Utrecht
Utrecht 3511 XA
If you have any questions, please contact Sabia Miah
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