Events

10th Risk Evaluation & Mitigation Strategies Summit (EXL)

lunes

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 Day 1  Monday, January 29, 2018 8:00AM – 8:45AM Registration and Continental Breakfast 8:45AM – 9:00AM Chairperson’s Opening Remarks Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE 9:00AM – 10:00AM REMS Carousel Discussion Exercise Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE Cheryl Renz, M.D., Head, Benefit-Risk Management Pharmacovigilance and Patient Safety (PPS), ABBVIE 10:00AM – 10:45AM Hot Off the Press: New FDA Initiatives and Guidelines Annette Stemhagen, MPH, DrPH, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UNITED BIOSOURCE CORPORATION 10:45AM – 11:15AM Networking Break 11:15AM – 11:45AM Integrate Consumer and Health Information Technologies Within the Primary Care Practice to Promote Safe Medication Use Stacy Cooper Bailey, Ph.D., MPH, Assistant Professor, Division of Pharmaceutical Outcomes and Policy, UNC ESHELMAN SCHOOL OF PHARMACY 11:45AM – 12:15PM Enhance Patient Understanding and Engagement by Knocking Down Barriers to Proper Medication Use Michael S. Wolf, Ph.D., MPH, Professor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY 12:15PM – 1:15PM Luncheon 1:15PM – 1:45PM Reduce the Burden on Pharmacists and HCPs Through Interoperable Technologies John Klimek, R.Ph., Senior Vice President, Standard and IT, NCPDP 1:45PM – 2:15PM Evaluate Patient Understanding of Risks: The Value of Cognitive Vs. Metacognitive Methods Ruth S. Day, Ph.D., Director, Medical Cognition Lab, Senior Fellow, Center for Aging and Human Development, DUKE UNIVERSITY 2:15PM – 3:00PM Benefit, Risk, Removals, and Corrections: Putting the Pieces Together Adam E. Saltman, M.D., Ph.D., FACS, FACC, FACP, FAHA, Medical Officer, CDRH Office of Compliance, FOOD AND DRUG ADMINISTRATION 3:00PM – 3:30PM Networking Break 3:30PM – 4:15PM CASE STUDY: Examine a Real-World Pharmaceutical Benefit-Risk Management Larry Risen, MBA, President and CEO, BIOTRAK RESEARCH 4:15PM – 5:15PM Overview of Recent FDA Guidances Impacting REMS Gita Toyserkani, Pharm.D., MBA, Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FOOD AND DRUG ADMINISTRATION 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, FOOD AND DRUG ADMINISTRATION 5:15PM – 5:45PM CO*RE and the Opioid REMS: Significant Learnings From an Eight-Year CE/CME Collaboration Cynthia Kear, Lead, Collaboration Management, CO*RE 5:45PM – 6:15PM Integrate REMS Requirements With the EHR and Provider Workflows Dean T. Parry, RPH, Assistant Vice President, Clinical Informatics, Care Support Services, GEISINGER HEALTH SYSTEM 6:15PM – Day One Concludes Day 2 Tuesday, January 30, 2018 8:00AM – 8:45AM Continental Breakfast 8:45AM – 9:00AM Chairperson’s Recap of Day One Emily Freeman, Ph.D., Director, Risk Management Sciences, ABBVIE 9:00AM – 9:45AM Integrating an Existing REMS Program Into Your Organization Following an Acquisition Kim H. Bullano, B.S., Pharm.D., Risk Management Team Lead, SHIRE 9:45AM – 10:30AM Incorporating HIT Within REMS Programs to Address REMS Stakeholder Burden Paul Sheehan, Executive Director, Head of U.S. REMS, CELGENE CORPORATION 10:30AM – 11:00AM Networking Break 11:00AM – 11:45AM Compare and Contrast REMS Program Models and Assessment Reporting Aspects Nathan Kopper, Pharm.D., Director, REMS Consulting and Strategy, MCKESSON Pat daCosta, Pharm.D., REMS Sr. Product Manager, RELAYHEALTH 11:45AM – 12:30PM Applying the RE-AIM Framework for REMS Assessments May Chan-Liston, Director, REMS Strategy and Policy, CELGENE CORPORATION 12:30PM – 1:30PM Luncheon 1:30PM – 2:15PM REMS Restrictions and Generic Entry: Trends and Developments in Legislative and Regulatory Activity Andrew Wasson, Partner, HAUG 2:15PM – 3:00PM Develop and Deliver Effective Evaluation of Risk Minimization Measures Michael von Forstner, Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE 3:00PM – 3:30PM Network Break 3:30PM – 4:15PM Incorporate Novel Approaches Into Real-World Data (RWD) to Evaluate Risk Minimization (RM) Interventions Rachel Sobel, Senior Director, Epidemiology - Group Lead Global Innovative Pharma, PFIZER 4:15PM – 5:00PM PANEL: Examine Best Practices in Developing and Operationalizing Shared REMS Kevin Holman, Senior Director, Drug Regulatory Affairs, ACTELION Deb Tiffany, Director, Global Risk Management Product Lead, Process Analyst, Worldwide Safety and Regulatory, PFIZER 5:00PM – Conference Concludes ----------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.comhttp://www.SFBayEventsList.com----------------------------------------------------------------- SHU170601CEV SON1710712UPD MYL170814OTH MAR170926UPT CHA171121UPT MAR20171124REV

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