Sep 12, 2018
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Sep 13, 2018
Please join Oracle Health Sciences strategists and solution experts in Utrecht on September 12-13 for this meeting, during which Oracle Argus and Oracle Health Sciences Empirica product updates and demos will be presented, and current 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.
This meeting is for Oracle Safety customers, and registration is monitored. Attendance is free of charge, but places may be limited due to the size of the venue, so we encourage you to register early to secure your place. Please see the Accommodation tab for details of local hotels you can book.
This meeting takes place 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 Kate Andrews 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.
September 12Registration and Refreshments Update on Global Safety Regulations Una Kessi, Product Management Director Safety and Pharmacovigilance, Oracle Health Sciences Oracle Health Sciences Safety Roadmap Bruce Palsulich, VP Safety Product Strategy, Oracle Health Sciences Artificial Intelligence for Transforming Case Management Bruce Palsulich, VP Safety Product Strategy, Oracle Health Sciences
Rave Harpaz, Senior Director Research and Data Science, Oracle Health Sciences Oracle Safety Cloud Consortium Update Robert Kelle, Senior Director Enterprise Safety Cloud Strategy, Oracle Health Sciences Can We Really Keep All Our On-Premise Argus Functionality When Moving to the Oracle Cloud? - Extensibility and Integrations in the Cloud Dimitris Kalaitzopoulos, Consulting Sales Director, Oracle Health Sciences Demo: What's New in Empirica and Preview the Forthcoming Signal and Topics New User Interface Robert Weber, Senior Product Strategy Manager, Oracle Health Sciences
Rob van Manen, Master Principal Solutions Consultant, Oracle Health Sciences Demo: What's New in Argus Rob van Manen, Master Principal Solutions Consultant, Oracle Health Sciences Case Studies for Upgrading Argus and Migrating to the Cloud Vipin Varkey Thomas, Leading Technology Consulting Practitioner, Accenture Life Sciences
Michael Braun-Boghos, Director Safety Analytics, Oracle Health Sciences Case Study: Artificial Intelligence in Medical Assessments Klaus Ristau, Project Manager PV System Architecture, Bayer AG
Magnus Lerch, Co-Founder & CEO, Lenolution GmbH NOTE: Agenda may be subject to changeSeptember 13Next-Generation Signal Detection and Safety Evaluation Rave Harpaz, Senior Director Research and Data Science, Oracle Health Sciences
William DuMouchel, Chief Statistical Scientist, Oracle Health Sciences Case Study: Getting the Best Data out of Argus Philippe Rogiers, Consulting Technical Management Director, Oracle Health Sciences How an AI Implementation Project Works Juergen Fakler, Consulting Sales Manager, Oracle Health Sciences Case Study: Improving Operational Efficiencies Through Automation Features and Process Improvements Stefan Knold, Senior Manager, Pharmacovigilance Technology, Ferring Pharmaceuticals
Martin Holm-Petersen, CEO, Insife Benefits of a Rapid Assessment Prior to an Argus Upgrade or Cloud Migration Mirco Becker, Head of Drug Safety Process Support & Applications, Grünenthal GmbH
Jeff Ho, Life Sciences Management Consultant, Navitas Life Sciences Ask the Experts: What are Your Burning Argus and Empirica Questions? Oracle Health Sciences Panel Wrap-up and Meeting Close Michael Braun-Boghos, Director Safety Analytics, Oracle Health Sciences NOTE: Agenda may be subject to changeThe meeting takes place in Utrecht, Netherlands, and venue details will be provided upon confirmation of registration.
Recommended local hotels include:
Carlton President Utrecht
Floraweg 25
Utrecht 3542 DX Note: The Carlton offers a courtesy bus service to the nearby meeting venue
NH Utrecht
Jaarbeursplein, 24
Utrecht 3521 AR
Park Plaza Utrecht
Westplein 50
Utrecht 3531 BL
Grand Hotel Karel V Utrecht
Geertebolwerk 1
Utrecht 3511 XA If you have any questions, please contact Kate Andrews.
Mirco Becker
Head of Drug Safety Process Support & Applications
Grünenthal GmbH Biography:
Mirco Becker is Head of Drug Safety Process Support & Applications at Grünenthal, where he works with an international team responsible for managing and optimizing the pharmacovigilance systems for users in more than 25 countries. He has been with the company since 2004, and in Drug Safety since 2007. Mirco has had several roles at Grünenthal, including Drug Safety Application Manager, Scientific Process Implementation Manager, and since 2013, Head of Drug Safety Process Support & Applications. Michael Braun-Boghos
Director of Safety Analytics
Oracle Health Sciences Biography:
Michael has been working in medicinal product safety for 23 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. William DuMouchel, PhD
Chief Statistical Scientist
Oracle Health Sciences Biography:
William DuMouchel is Chief Statistical Scientist at Oracle Health Sciences. His current research focuses on statistical computing and Bayesian hierarchical models, including applications to meta-analysis and data mining. Dr. DuMouchel has developed data mining algorithms for drug adverse event associations in spontaneous reports and in clinical research data that have been used widely within regulatory agencies and industry. Dr. DuMouchel received the Ph.D. in Statistics from Yale University and has been a member of the faculties of the University of California at Berkeley, the University of Michigan, MIT, and Columbia University. Juergen Fakler
Consulting Sales Manager
Oracle Health Sciences Biography:
Juergen has been working as a Sales Manager at Oracle Health Sciences for more than 10 years. Since the acquisition of Relsys by Oracle, he addresses customer needs in Pharmacovigilance by providing professional services for Oracle Argus in the European market. Prior to joining Oracle Health Sciences, he held various roles within Oracle, on the sales side as well as on the consulting services side.
He started his career in a professional services organization in Austria in which he had various roles, including software development, business consulting, project management, sales management, and ultimately leading the company as a Managing Director for 10 years, growing it from 10 to 60 Consultants.
Juergen holds a Master degree in Computer Science from the Technical University of Vienna, Austria. Rave Harpaz
Senior Director Research and Data Science
Oracle Health Sciences Biography:
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. Jeff Ho
Life Sciences Management Consultant
Navitas Life Sciences Biography:
Jeff Ho is a Principal Consultant with Navitas Life Sciences and has advised PV organisations for 20 years. He has helped large and mid-sized companies with selecting, implementing, and integrating software solutions including RPA. He has also helped embed compliant, fit-for-purpose PV processes, designed affiliate operating models to support company growth, and established cross-functional B-R and medical governance.
Jeff holds a degree in Math / Computer Science and Psychology from Carnegie Mellon University. Martin Holm-Petersen
CEO
Insife Biography:
With 10 years of experience within the pharmaceutical industry and another 10+ years in consulting, Martin is an experienced manager and strategist, with understanding across the pharma business value chain. His current role is CEO of Insife, a consulting and technology company, supporting life sciences companies. In his previous role, he headed the pvtech global industry pharmacovigilance technology network with more than half of top 100 pharma participating.
From industry, Martin has seven years of experience at Director level, and has furthermore been engaged as a senior governance Board member for project investments at a top 10 pharmaceutical company.
Martin holds an MSc Communication Studies. Robert Kelle
Senior Director Enterprise Safety Cloud Strategy
Oracle Health Sciences Biography:
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. Una Kessi
Product Management Director Safety and Pharmacovigilance
Oracle Health Sciences Biography:
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. Dimitris Kalaitzopoulos
Consulting Sales Director
Oracle Health Sciences Biography:
Dr. Dimitris Kalaitzopoulos is Director of Consulting Sales for the EMEA and APAC regions at Oracle Health Sciences, where he leads Consulting Sales for Oracle’s Safety, Life Sciences, and Healthcare product portfolios. Prior to that, Dimitris was part of the Health Sciences Consulting (HSC) delivery organisation, where he worked in several customer implementations as a subject matter expert.
Over the past 12 years, Dimitris has built extensive experience in the implementation and deployment of enterprise data management and analytics platforms at leading healthcare and life sciences organisations globally. This work has given him a deep understanding of the business issues, industry challenges and best practices associated with data integration and management, including data governance and business process change.
Dimitris holds a PhD in Molecular Cytogenetics and Bioinformatics from The Sanger Institute and the University of Cambridge.
Stefan Knold
Senior Manager, Pharmacovigilance Technology
Ferring Pharmaceuticals Biography:
Stefan Knold is Senior Manager of Ferring’s Pharmacovigilance Technology section in Global Pharmacovigilance. In this role he is responsible for the global Oracle Argus Safety database, so there is never a day that goes by when regulations don’t come into play.
Stefan has worked in the pharmaceutical industry for 13 years, at three different companies. His main responsibility has been on implementing and managing global GxP critical systems according to GAMP 5, so has had a keen focus on, and has developed an advanced level of knowledge of computerized system compliance, and the associated regulatory requirements.
Stefan holds a masters (Cand. mag.) in Human Centered Informatics, with the focus on communication between computers. He is specialized in the human-computer-interaction where processes are the key to success. Magnus Lerch
Co-Founder and CEO
Lenolution Biography:
Dr Magnus Lerch, MD MSc, is medical doctor and computer scientist with 16 years' experience in pharmacovigilance and with Oracle Argus Safety, and later with Oracle Argus Insight and Oracle Health Sciences Empirica Signal and Topics. He was head of the PV data analysis group at Schering/Bayer where he, among many other things, co-developed Bayer's in-house signal detection system that was productive from 2008 to 2014.
In 2009, he became a freelance consultant, and in 2014 co-founder of Lenolution, a consulting company specialized in data analysis, signal detection and tailor-made PV system customizations. He is developer of Cognium, a self-learning tool for automated case assessment. Bruce Palsulich
VP Product Strategy
Oracle Health Sciences Biography:
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. Philippe Rogiers
Consulting Technical Management Director
Oracle Health Sciences Biography:
Philippe Rogiers is Technical Consulting Director with Oracle HSC based in Paris, France.
He has 15 years of experience working in the Pharmacovigilance industry on Global and Japan Safety system implementations.
He worked from 2005 until 2009 for Relsys who developed Argus Safety and has worked for Oracle HSC since in solution architect and project management roles, broadening his experience across the full range of Oracle Safety products and technologies and managing the HSC Safety EU team.
He is an expert on integration of Oracle OBI, ODI and B2B with Argus Safety.
He has a Civil Engineering degree from the University of Leuven, Belgium, a MBA from the University of Chicago and is a certified 6 Sigma Black Belt. Robbert P. van Manen, M.Sc., B.Sc.
Master Principal Solutions Consultant
Oracle Health Sciences Biography:
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. Vipin Varkey Thomas
Leading Technology Consulting Practitioner
Accenture Life Sciences Biography:
Vipin is a leading technology consulting practitioner in the Accelerated R&D Service line within Accenture's Life Sciences Practice. He has 10 years of experience working in the pharmacovigilance industry on safety system implementations. Vipin has led teams in the development and support of various drug safety systems, Oracle Argus implementations, upgrades and support. He is also an expert in E2B / gateway connectivity with regulatory agencies and pharmaceutical companies.
Mr. Thomas holds a Bachelor's degree in Computer Science and Engineering from CUSAT, India. 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 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. TitleDonec vel placerat quam, ut euismod risus. Sed a mi suscipit, elementum sem a, hendrerit velit. Donec at erat magna. Sed dignissim orci nec eleifend egestas. Donec eget mi consequat massa vestibulum laoreet. Mauris et ultrices nulla, malesuada volutpat ante. Fusce ut orci lorem. Donec molestie libero in tempus imperdiet. Cum sociis natoque penatibus et magnis. 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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