10th Risk Evaluation & Mitigation Strategies Summit (EXL)


29 ene, 2018 – 8:00 A.M.

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10th Risk Evaluation & Mitigation Strategies Summit ExL Events is proud to announce the 10th anniversary of the Risk Evaluation & Mitigation Strategies Summit. This event continues to attract the most elite professionals, hailing from branded and generic pharmaceutical and biotech companies with responsibilities in risk management. Over the past decade, REMS professionals have depended on this summit for comprehensive elucidation in achieving compliance and innovation in an evolving healthcare landscape. We welcome you to witness firsthand why our event remains the conference of choice for REMS professionals. Our star-studded speaking faculty will arm you with the proven strategies to facilitate benefit-risk counseling, optimize REMS through health system integration, leverage technological advances and accomplish much more! The 10th REMS Summit provides you with the tools and methods to evaluate and improve a compliant REMS program, in order to improve patient safety and outcomes. Top Five Reasons to Attend Fashion nimble structures for prompt risk identification and timely responses Evaluate your REMS program to determine the necessary methods to ensure compliance Assess patient safety and outcomes to refine REMS accordingly Determine solutions to integrate REMS with healthcare systems and pharmacies Promote patient outcomes by leveraging technological advances Who Should Attend This event is ideal for professionals from payers and pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas: REMS Risk Management Pharmacovigilance/Surveillance Quality Assurance Drug/Product Safety Clinical Risk Management Life Cycle Management Regulatory Affairs/Legal/Compliance Clinical Affairs Clinical Data Management Clinical Operations Clinical Risk Management Compliance Epidemiology/Pharmacoepidemiology Marketing This conference is also of interest to: Risk Safety and REMS Service Providers Data Management Service Providers Healthcare Information Marketing and Technology Providers Dashboard and Metrics Service Providers Law Firms Consultancies Agenda The 10th REMS Summit agenda is currently in development. The following topics are under consideration for this event: Regulatory/Compliance Learn the outlook and ramifications of structured product labeling Ace your audit with relevant documentation, effective negotiation and tactical preparation Compare and contrast the EMA’s RMP and the FDA’s REMS REMS Implementation/Management Expand a REMS program/harmonize REMS Develop methods and metrics to assess REMS compliance Gauge progress toward goals of REMS using eDashboards Fashion nimble structures for prompt risk identification and timely responses Evaluation Assess REMS efficacy with proven methods and targeted metrics Analyze outcome indicators and metrics to assess the benefits of REMS programs Determine data collection criteria and methods for the optimal evaluation of REMS compliance Develop metrics to measure the impact of communications Improve the effects of risk minimization components through outcome indicator analysis Collaboration and Change Management Establish internal collaborations with effective structures for REMS implementation Collaborate on a single shared REMS Foster cultural change to improve safety and patient outcomes Cultivate allies through a benefit-focused approach Communication and Technology Vet best practices for integration with healthcare providers Learn tools and tactics to manage and monitor REMS Identify opportunities and avoid pitfalls in communicating REMS Leverage the advent of mobile devices and apps for your REMS program ----------Faculty---------- Stacy Cooper Bailey, Ph.D., MPHAssistant Professor, Division of Pharmaceutical Outcomes and Policy, UNC ESHELMAN SCHOOL OF PHARMACY   Kim H. Bullano, B.S., Pharm.D.Senior Director, Risk Management Team Lead, SHIRE   May Chan-Liston, Director REMS Strategy, CELGENE CORPORATION   Pat daCosta, Pharm.D.REMS Sr. Product Manager, RELAYHEALTH   Ruth S. Day, Ph.D.Director, Medical Cognition Lab, Senior Fellow, Center for Aging and Human Development, DUKE UNIVERSITY   Michael von ForstnerCo-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE   Emily Freeman, Ph.D.Director, Risk Management Sciences, ABBVIE   Kevin HolmanSenior Director, Drug Regulatory Affairs, ACTELION   Cynthia KearLead, Collaboration Management, CO*RE   John Klimek, R.Ph.SVP Standards and IT, NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS, INC   Nathan Kopper, Pharm.DDirector, REMS Consulting and Strategy, MCKESSON   Cheryl Renz, M.D.Head, Benefit-Risk Management Pharmacovigilance and Patient Safety (PPS), ABBVIE   Larry Risen, MBAPresident and CEO, BIOTRAK RESEARCH   Suzanne Robottom, Pharm.D.Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FDA   Adam E. Saltman, M.D., Ph.D., FACS, FACC, FACP, FAHAMedical Officer, CDRH Office of Compliance, FOOD AND DRUG ADMINISTRATION   Linda Scarazzini, M.D.Vice President, Pharmacovigilance and Patient Safety (PPS), ABBVIE Rachel SobelSenior Director, Epidemiology - Group Lead Global Innovative Pharma, PFIZER   Deborah TiffanyDirector, Global Risk Management Product Lead, Process Analyst, Worldwide Safety and Regulatory, PFIZER   Gita Toyserkani, Pharm.D., MBARegulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FDA   Andrew WassonPartner, HAUG   Scott Wirth, Pharm.D.BCOP, Clinical Assistant Professor, Department of Pharmacy Practice Clinical Pharmacist, Oncology, UNIVERSITY OF ILLINOIS AT CHICAGO COLLEGE OF PHARMACY   Michael Wolf, Ph.D., MPHProfessor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY Please contact the event manager Marilyn below for the following: - Discounts for registering 5 or more participants.- If you company requires a price quotation.Event Manager Contact: marilyn.b.turner(at)nyeventslist.comYou can also contact us if you require a visa invitation letter, after ticket purchase. We can also provide a certificate of completion for this event if required.NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS -----------------------------------------------------------------This Event Listing is Promoted byNew York Media Technologies LLC in associationwith EXL Events Inc.http://www.NyEventsList.comhttp://www.BostonEventsList.com SHU170601CEV SON1710712UPD MYL170814OTH MAR170926UPT CHA171121UPT

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