Breakfast Buffet Location: Rose Garden Promenade (19th Floor)

Transcription

1 Wednesday 6:30 8:30pm Cocktail Reception at Hyatt at the Bellevue Thursday All sessions in the Rose Garden Ballroom 8:00 9:00am 9:00 9:10am S1 1 9:10 9:40am S1 2 9:40 10:40am S1 3 Breakfast Buffet Location: Rose Garden Promenade (19th Floor) Welcome Host: Axel Hagel, Foresight Group Keynote Address Speaker: John Ferguson, Shire What s New in Argus 8.1 Argus and Argus J Regulatory background and release approach & roadmap Major enhancements and bug fixes Speaker: Axel Hagel, Foresight Group 10:40 11:00am Coffee Break 11:00 12:00pm S1 4 Oracle Suite Update Update of the Argus Suite Release Roadmap Speaker: Bruce Palsulich, Oracle 12:00 1:00pm 1:00 1:45pm S1 5 1:45 2:45pm S1 6 Lunch PV and the Future What are the major trends in healthcare that will shape PV? Very specific trends push towards better methods and new models in observational data, collapsing of distinction between pre/post market obligations and complete ubiquity of data. Speaker: Mike Ibara, CDISC All About E2B R3 Why we need R3 and overview of E2B R3 requirements Comparison of R2 and R3 and Identification of Medicinal Products (IDMP) Implementation timelines Speaker: Uwe Trinks, Foresight Group 2:45 3:00pm Coffee Break 3:00 4:00pm S1 7 E2B R3 What Does it Mean to You? An Industry Perspective on how to prepare and implement R3 Speaker: Raymond Kassekert, GSK Case Versioning & Data Lock Point Overview of the requirements and functionality. How is the industry viewing this feature? 4:00 5:00pm S1 8 Attendee Panel Discussion Panel: Industry / facilitated by Axel Hagel, Foresight Group Dinner Event 6:30 10:00pm Location: 2nd Story Brewing Company AUG Philadelphia, October 2016 Page 1

2 Friday Track A will continue in this room, track B is in Cliveden 8:00 9:00am 9:00 10:45am S2 1 Breakfast Buffet Location: Rose Garden Promenade (19th Floor) Ask the Experts Questions submitted by attendees Audience discussions Panel: Uwe Trinks, Axel Hagel, Saurabh Khurana, Foresight Group 10:45 11:00am Coffee Break Track A: Rose Garden Ballroom Argus Implementation: Building a new Business Process and how it was adapted in the Argus Workflow 11:00 12:00pm S2 2a Does and the don ts of transferring a business process to an Argus WF Speaker: Sapna Elzer, Sanofi & Karen Schriemer, Foresight Group 12:00 1:00pm 1:00 1:45pm S2 3a 1:45 2:45pm S2 4a 2:45 3:00pm Coffee Break 3:00 4:00pm S2 5a 4:00 4:50pm S2 6 4:50 5:00pm S2 7 Lunch Introduction of Argus J and PMDA Reporting for non Japanese What you need to know when you integrate your Japan affiliate into Argus Speaker: Axel Hagel, Foresight Group How to deal with the deficiencies of Argus Affiliate Argus vs. Argus Affiliate Workarounds that companies have implemented Panel: Industry / facilitated by Saurabh Khurana, Foresight Group Case Intake Approach and experiences of increasing your case intake capabilities using thirdparty solutions. Speaker: Sheila Bell, Novartis Sean Green, Pharmacyclics & Ted Chin, Foresight Group S2 2b S2 3b S2 4b S2 5b Track B: Cliveden How to take the Argus Configuration to the next Step Achieving flexibility and ease of maintenance through some innovative customizations Speaker: Denny Lorenz, Bayer Social Media and Pharmacovigilance The current regulations and what to do now. Working smarter not harder; What does the future hold? Speaker: Graeme Ladds, PharSafer Two Years in the Life (Post Go Live) Managing a complex go live technology and process considerations what lies ahead? Speaker: LuAnn Hagerty, GSK Expedited reporting monitoring in Argus The pitfalls for expedited report submission that should keep you up at night and what you can do to monitor them. Speaker: Kristof Huysentruyt, UCB Panel Discussion IDMP Overview of IDMP and the challenges ahead. How is industry preparing for IDMP? Panel: Industry / facilitated by Uwe Trinks, Foresight Group Closing Remarks & Next AUG Host: Axel Hagel, Foresight Group AUG Philadelphia, October 2016 Page 2

3 Ms. Sheila Bell has worked in Pharmacovigilance within Novartis Pharmaceuticals Corporation for over 11 years. Over the past three years, she has had responsibility over the US Safety Operations teams as US Pharmacovigilance Head of Operations at Novartis Pharmaceuticals Corporation. In her role as US PV Head of Operations, she has oversight of the day-to-day PV operations for the US safety team and vendors supporting US PV activities. Prior to this, she held positions of increasing responsibility from US Drug Safety Specialist, US Team Lead/Group Head and US Drug Safety Responsible (ad interim). While at Novartis she has supported multiple projects related to ARGUS system s upgrades, enhancements and system migration activities as well supported projects related to testing and implementation of ARGUS system s interfaces. She s currently involved in a collaborative cross-functional team working on the Argus 8.x Upgrade Project in which she and other colleagues provide valuable input from a CPO perspective. Sheila is a nurse by background with over 15 years of emergency room experience. She received her Bachelors of Nursing degree from Ramapo College/University of Medicine & Dentistry of NJ. Ted Chin is a pharmaceutical R&D executive with extensive management experience in drug development, project/program management, clinical operations, electronic data capture, data management, biostatistics, regulatory affairs and compliance, finance, pharmacovigilance, post-marketing surveillance, IT solution delivery, business process design, and staff development and training. He recently retired after spending over 30 years with GlaxoSmithKline. During his tenure with GSK, Ted spent a significant part of his working life integrating the Japan and the Asia-Pacific R&D processes into Global operations. Prior to joining Foresight, Ted was the Japan Lead for GSK s successful global implementation of Argus/Argus-J. Sapna Elzer is the Global Safety Database Operations Manager at Sanofi with over 18 years of experience in Global Pharmacovigilance including Case Data Entry, Ad hoc reporting, E2B processes & standards, Global User Support, Quality Document Management and Training. Ms. Elzer has held various positions within Sanofi with increasing responsibility. Currently she manages a global team of safety database experts and is responsible for business operations and safety database enhancements. Ms. Elzer is part of the extended PMO responsible for design and implementation of all Configuration aspects for the Argus database implementation AEGIS within Sanofi. Dr. Ferguson is a board certified Cardiologist and former co-principal NIH and the MRCC investigator. Ferguson received his training in Cardiology and Clinical Epidemiology at McGill University, McMaster University and Cedars-Sinai Medical Center. He is a Fellow of the Royal College of Physicians and Surgeons of Canada and Diplomate of American Board of Internal Medicine, with certifications in Internal Medicine and Cardiovascular Diseases. Prior to entering the pharmaceutical industry his research focused on expert systems, risk prediction in coronary artery disease and catheter-based interventions for prevention and treatment of ischemic stroke. In a 20 year career as head of clinical safety and risk management, he has contributed to the approval and benefit-risk management of small molecules, biologics and vaccines. Concurrently he served on clinical trial, safety, risk management and benefit-risk management committees at PhRMA and BIO, as well as acting as a key subject matter expert for the Institute of Medicine (IOM). His current work focuses on adaptive product development pathways and developing scientific and structured approaches to characterizing, optimizing and communicating the benefit-risk balance of medicinal products. AUG Philadelphia, October 2016 Page 3

4 Axel Hagel has over 21 years of experience in the life sciences industry, specializing in the deployment of drug safety applications in North America, Europe, and Japan. He has unique experience and implementation skills for the Argus Safety Suite, including Argus J, and is recognized in the drug safety sector as a Pharmacovigilance industry leader. Prior to Foresight, Mr. Hagel served as the North American Practice Partner for Deloitte. Prior to that position, Mr. Hagel was Vice President of Drug Safety at Relsys International, Inc., the developer of Argus Safety Suite before its acquisition by Oracle. Mr. Hagel completed his Bachelor of Computer Science with High Honors at Carleton University in Ottawa, Canada. LuAnn Hagerty has worked at GSK for 16 years performing IT roles in development, project management, support, with the current role of IT Service Manager (Support) of Safety applications which includes Argus. Prior to GSK, she was a consultant as an Oracle, Sybase and DB2 DBA. Kristof Huysentruyt has 10 years of experience in the Life Science industry. He joined PV 7 years ago and was involved in system implementation and process improvement projects around single case handling and aggregate reporting, and lead the Argus implementation project at UCB. Since 2014, he is leading the safety solutions team, responsible for operational systems, safety reporting, safety surveillance and digital safety. His current role is head of safety data management and technology at UCB. Dr. Michael Ibara is Head of Digital Healthcare for CDISC where he works at the interface of digital health, standards and industry. Currently he oversees the FDA esource project and several Healthcare Link efforts with registries, clinical trials and mobile health. Dr. Ibara has over 20 years experience at the intersection of technology and healthcare in domestic and international settings. Previously he was Head of Business Development Coordination and Innovation at Pfizer, where he worked for 15 years in various positions, leading implementations of global systems and large-scale technologies. Michael pioneered research on the implications of digitized healthcare data on pharmacovigilance practice and drug safety, specifically with the goal of developing a new business model for pharmacovigilance. He designed and lead the ASTER project, which used CDISC Healthcare Link standards and was the first time adverse events were retrieved directly from an electronic health record and delivered to FDA. He also designed ASTER-D, a similar project to allow collection of device reports. His work spawned similar efforts in the UK and Japan. Michael s interest include regulatory and policy implications for digital healthcare, exploring the factors needed to allow interoperability of healthcare data for all stakeholders involved, and implications for the use of big data and social media to deliver high-quality adverse event information. He received his Pharm.D. degree from the University of Michigan and completed a Fellowship in Drug Research and Development with Burroughs Wellcome, Inc. and the University of North Carolina. AUG Philadelphia, October 2016 Page 4

5 Raymond Kassekert is the Director, Pharmacovigilance Application Development and Support at GSK with more than 15 years of experience in developing, implementing and supporting drug safety systems. At GSK, Ray is responsible for managing the portfolio of systems and tools used in pharmacovigilance, sets the strategic direction for technology investments supporting drug safety and chairs the PV Systems Management and Oversight Board. Through PhRMA, Ray is an active member of the ICH E2B(R3) IWG and has extensive background and experience in implementing and supporting E2B. Prior to joining GSK, Ray spent more than 10 years at Merck developing and supporting IT systems used in pharmacovigilance and clinical risk management. Mr. Saurabh Khurana is a Partner at Foresight Group based in Noida, India, with over 12 years of experience in drug safety. Mr. Khurana specializes in the development, implementation, integration, and operation of systems within the drug safety industry. He has unique combination of experience and implementation skills for the Argus Safety Suite, which also includes Argus J. He has done extensive work on very large data migrations from Global as well as Japanese data sources. Prior to Foresight, Mr. Khurana worked at Relsys India and United States as an Application Architect. He led the product architecture of Argus Safety 4.2+ and 5.x product versions. Mr. Khurana holds Bachelor of Technology and Master of Technology degrees in Computer Science from the Indian Institute of Technology in New Delhi. Dr. Graeme Ladds, Director of PharSafer, has over 20 years experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. The last ten years have been spent in his consultancy company, PharSafer Associates Ltd. Denny Lorenz has a background in business informatics and consumer health care. He has 14 years of experience in life-science companies, joining PV 11 years ago with a strong focus on electronic reporting, global expedited case distribution and single case handling. Being responsible in different roles for system configuration, customization and reference data maintenance he is currently leading the PV System Management & Analytics function in Bayer Pharma AG. Through EFPIA, he is a standing member of the ICH E2B R3 EWG and the EudraVigilance EWG. For IDMP he is involved as PV representative within Bayer. Bruce Palsulich has over 25 years of experience in the Healthcare and Life Science industry. Bruce heads safety product strategy for Oracle Health Sciences. This portfolio includes Argus Safety, the industry leading adverse event case processing and analytics solution, and Empirica, the standard for signal detection and risk management across clinical, post-market and observational data sources.prior to joining Oracle, Bruce was one of the founders and served as Vice President of Relsys International. At Relsys he led the strategy and development of the Argus Safety suite of products before serving as President of Timeln Inc. He later returned to Relsys as the Chief Innovation and Strategy Officer. Bruce joined Oracle through the acquisition of Relsys. Ms. Karen Schriemer is a principal consultant in the Business Transformation Practice at Foresight Group. She has 17 year of experience in life sciences industry, 8 in Pharmacovigilance. She has held various roles in the industry, including nursing, clinical research, data management and pharmacovigilance product life cycle management. She completed her degree in healthcare at INHOLLAND Amsterdam and a post graduate in research coordination at the hogeschool Roterdam, Netherlands Dr. Uwe Trinks has over 30 years of life sciences experience having served as the Executive Director and Head Research Information Management for Novartis before becoming the CIO of Sentrx for ten years leading the hosting and managed services of over 25 Argus safety database instances prior to joining Foresight Group. Dr. Trinks earned a M.S., Major: Organic Chemistry and Natural Products Chemistry, from Federal Institute of Technology in Zurich, Switzerland and a Ph.D. Organic Chemistry also from Federal Institute of Technology. Dr. Trinks also has completed Postdoctoral Research in Biochemistry from Stanford University. AUG Philadelphia, October 2016 Page 5