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Oracle Health Sciences Safety Consortium – Virtual Event 2020: Shaping the Future of Safety

Live virtual event
29-30 September, 2020
Start time: 7AM PT / 10AM ET / 3PM BT / 4PM CET
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Virtual Event 2020: Shaping the Future of Safety

As we’re not able to physically meet this year but don’t want to miss the opportunity to advance safety with our industry peers, we’re pleased to announce that our yearly face-to-face Oracle Safety Consortium meeting is going virtual.

Please join Oracle Health Science strategists, product managers, and solution experts online on September 29-30, 2020 for 2 half-days packed with product updates and thought-leadership content. We will present Argus, Safety One Intake and Empirica product updates and demos, and discuss the future of pharmacovigilance including automation, AI, and predictive analytics, as well as the impact of the pandemic on our industry. We'll explore the future of case management and signal management in the coming years, the latest in safety regulations, and look at Oracle’s strategic safety roadmap. The Consortium program will include an update on our working groups as well.

This meeting is for Oracle Safety customers and partners, and registration is monitored. Attendance is free of charge and space is unlimited so feel free to invite your peers.

Register now to secure your place! Please contact Celine Stenson should you have any questions.

PLEASE NOTE: As registration is monitored, the virtual event links will be provided upon registration confirmation.

Agenda: Tuesday 29 September, 2020

30 mins
The compass arrow: Where is Oracle Safety heading?
Speaker:
Bruce Palsulich
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.

Bruce earned a Bachelor of Science in Information and Computer Science from the University of California, Irvine.
30 mins
Newsflash: regulatory updates
Speaker:
Una Kessi
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.

*Oracle Newsflashes: guaranteed to be free from fake news!
30mins
Newsflash: Argus updates
Speaker:
Beena Wood
Senior Director, Argus Product Management
Oracle Health Sciences


Having been with Oracle Health Sciences Safety for over 15 years, Beena currently leads the Oracle Argus Product Management team. She has an engineering background and has worked in IT/product development for over 25 years across multiple domains. But Multivigilance is her field of interest because Beena is passionate about helping keep patients safe. This is how she drives the development of Argus: helping our customers keep compliant with regulations and building the next generation Safety One platform to help them focus on what is important to keep patients safe. Beena feels fortunate to being part of a great team as well as something that matters to human lives.

*Oracle Newsflashes: guaranteed to be free from fake news!
30mins
Newsflash: Safety One Intake updates
Rave Harpaz
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.

*Oracle Newsflashes: guaranteed to be free from fake news!
60 mins
Roundtable: Rethinking PV – how can we turn safety from a cost center into an asset?
Bruce Palsulich
VP Safety 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.
Bruce earned a Bachelor of Science in Information and Computer Science from the University of California, Irvine.

Agenda: Wednesday 30 September, 2020

30 mins
Newsflash: Empirica updates
Speakers: Robert Weber & Rob van Manen

Robert Weber
Senior Product Strategy Manager
Oracle Health Sciences

Biography:
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 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 organization, in Berlin and London; Senior Project Manager at DocCheck Medical Services in Cologne; and Principle Consultant at Phase Forward's Lincoln Safety Group.


Rob van Manen
Master Principal Solutions Consultant
Oracle Health Sciences

Biography:
Rob 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.

Rob 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, Rob 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, Rob 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.

Rob 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.

*Oracle Newsflashes: guaranteed to be free from fake news!
60 mins
Working Group highlights from 2020
60 mins
Roundtable: Automation, AI and touchless case processing
Bruce Palsulich
VP Safety 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.
Bruce earned a Bachelor of Science in Information and Computer Science from the University of California, Irvine.
30 mins
Ask the experts – Everything you always wanted to know but were afraid to ask
Moderated by:

Michael Braun-Boghos
Senior Director, Safety Strategy
Oracle Health Sciences

Michael has been working in medicinal product safety for 25 years. He spent 13 years in the European PV headquarters of Fujisawa, which later became 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 senior director in the safety strategy team, he helps drive the product roadmap of the Oracle Safety Cloud.

Oracle is committed to promoting a corporate culture that is centered on integrity, accountability and ethical business conduct. Please click here for important ethics information regarding this event.

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