Risk Evaluation & Mitigation Strategies Share, Learn and Develop Patient-Centered Practices in Risk Mitigation to Ensure Compliance, Increase Patient Safety and Improve Patient Outcomes 9 th January 26-27, 2017 Hilton Crystal City at Reagan National Airport | Arlington, VA REMS EFFORT OUTPUT Patient Outcomes Risk Mitigation Education Patient Safety Patient Outcomes Risk Mitigation Education Patient Safety Compliance Compliance Technology Standardization Shared Decision-Making Assessment Integration Technology Standardization Shared Decision-Making Assessment Integration SUMMIT 24+ Featured Stakeholders, Including: PHARMA PATIENT ADVOCATES HEALTHCARE DELIVERY SYSTEM REGULATORY EXPERTS ACADEMIANS Gary Appio JAZZ PHARMACEUTICALS Penney Cowan AMERICAN CHRONIC PAIN ASSOCIATION Kim McCleary FASTERCURES Adam Bursua UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM Molly Billstein Leber YALE-NEW HAVEN HOSPITAL Adam Kroetsch FOOD AND DRUG ADMINISTRATION Elaine H. Morrato COLORADO SCHOOL OF PUBLIC HEALTH Michael Wolf NORTHWESTERN UNIVERSITY Thomas Felix AMGEN Peter McCroskery BIOGEN Paul Sheehan CELGENE Kevin Holman ACTELION Top Reasons to Attend • Determine solutions to integrate REMS with healthcare systems and pharmacies • Plan for modifications resulting from REMS, RMP and PDUFA 6 developments • Incorporate an app/technological tool as a medium to promote patient health literacy • Evaluate patient safety/outcomes to determine and modify REMS accordingly • Facilitate shared treatment decision-making between patients and providers Chairperson Emily Freeman ELI LILLY SPONSORS
Transcript
Risk Evaluation & Mitigation Strategies
Risk Evaluation & Mitigation Strategies
Risk Evaluation & Mitigation Strategies
Share, Learn and Develop Patient-Centered Practices in Risk Mitigation to Ensure Compliance, Increase Patient Safety and Improve Patient Outcomes
Share, Learn and Develop Patient-Centered Best Practices in Risk Mitigation to Ensure Compliance, Increase Patient Safety and Improve Patient Outcomes
9th
9th
9th
January 26-27, 2017Hilton Crystal City at Reagan National Airport | Arlington, VA
January 26-27, 2017Hilton Crystal City at Reagan National Airport | Arlington, VA
To register, call 866-207-6528 or visit http://exlevents.com/REMSTo register, call 866-207-6528 or visit http://exlevents.com/REMS
SUMMIT
SUMMIT
SUMMIT
SPONSORS
Dear Colleague,
The evolution of REMS engendered numerous innovations, adaptations and best practices suited to address the needs of stakeholders. The 9th REMS Summit will bring together the REMS professional community to propagate the core principles of risk management and to help ensure success. This conference aims to disseminate practices, tools and methods that advance the development of REMS.
We are proud to showcase the industry’s gold standard practices related to integration, shared decision-making, technological tools and evaluation methods. This event provides an environment in which REMS leaders can discuss lessons learned; gain the skills needed to innovate at work; and navigate the production and execution of REMS programs that effectively minimize risk, ensure fidelity to REMS and improve patient outcomes.
In addition to sharing best practices, our skilled faculty members will also explore the burden that REMS programs place on healthcare providers, pharmacists and patients. Stakeholders will expose how REMS can impede care and spotlight model REMS programs worth replicating. As a result, attendees will be able to not only “lesson” the burden of REMS, they will also learn to augment REMS programs to support stakeholders at the point of care.
This summit will provide the latest regulatory REMS and RMP updates related to standardization, integration and Structured Product Labeling. Additionally, attendees willbenefit from an overview of the history of REMS and projections on what is in store for its future and how the Prescription Drug User Fee Act (PDUFA) 6 will impact their work.
I look forward to seeing you in January in Arlington.
Sincerely,
BrianBrian L. AndersonConference Production Director
VENUEHilton Crystal City at Reagan National Airport
2399 Jefferson Davis HwyArlington, VA 22202
Enjoy your stay at this conveniently located hotel in Crystal City, Virginia, only 10 minutes from downtown Washington, DC and adjacent to Ronald Reagan Washington National Airport (DCA). With complimentary shuttle bus service to the Crystal City Metro station and close proximity to shops and restaurants, this hotel is perfectly situated for your next visit to Arlington, VA.
If you require overnight accommodations, please contact the hotel to book your room. ExL has reserved a block of rooms at a group rate for conference participants. To make reservations, guests can call 1-800-695-7551 and request the group rate for ExL’s January Meetings. The group rate is available until January 5. Please book your room early, as rooms available at this rate are limited.
ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at [email protected]. ExL Events has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL Events’ reserved guest room block using the details provided.
WHO SHOULD ATTEND?This conference is designed for representatives from biotech and pharmaceutical companies with responsibilities in the following areas:
• Risk Safety and REMS Service Providers• Data Management Service Providers• Consultancies• Dashboard and Metrics Service
Providers• Law Firms• Healthcare Information Marketing and
Technology Providers
Sponsorship and Exhibit OpportunitiesDo you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL will work closely with you to customize a package that suits all of your needs.
To learn more about these opportunities, contact Alex Siegel at 917-242-3893 or [email protected].
To register, call 866-207-6528 or visit http://exlevents.com/REMSTo register, call 866-207-6528 or visit http://exlevents.com/REMS
SUMMIT
SUMMIT
SUMMIT
SPONSORS
Dear Colleague,
The evolution of REMS engendered numerous innovations, adaptations and best practices suited to address the needs of stakeholders. The 9th REMS Summit will bring together the REMS professional community to propagate the core principles of risk management and to help ensure success. This conference aims to disseminate practices, tools and methods that advance the development of REMS.
We are proud to showcase the industry’s gold standard practices related to integration, shared decision-making, technological tools and evaluation methods. This event provides an environment in which REMS leaders can discuss lessons learned; gain the skills needed to innovate at work; and navigate the production and execution of REMS programs that effectively minimize risk, ensure fidelity to REMS and improve patient outcomes.
In addition to sharing best practices, our skilled faculty members will also explore the burden that REMS programs place on healthcare providers, pharmacists and patients. Stakeholders will expose how REMS can impede care and spotlight model REMS programs worth replicating. As a result, attendees will be able to not only “lesson” the burden of REMS, they will also learn to augment REMS programs to support stakeholders at the point of care.
This summit will provide the latest regulatory REMS and RMP updates related to standardization, integration and Structured Product Labeling. Additionally, attendees will benefit from an overview of the history of REMS and projections on what is in store for its future and how the Prescription Drug User Fee Act (PDUFA) 6 will impact their work.
I look forward to seeing you in January in Arlington.
Sincerely,
BrianBrian L. AndersonConference Production Director
VENUEHilton Crystal City at Reagan National Airport
2399 Jefferson Davis HwyArlington, VA 22202
Enjoy your stay at this conveniently located hotel in Crystal City, Virginia, only 10 minutes from downtown Washington, DC and adjacent to Ronald Reagan Washington National Airport (DCA). With complimentary shuttle bus service to the Crystal City Metro station and close proximity to shops and restaurants, this hotel is perfectly situated for your next visit to Arlington, VA.
If you require overnight accommodations, please contact the hotel to book your room. ExL has reserved a block of rooms at a group rate for conference participants. To make reservations, guests can call 1-800-695-7551 and request the group rate for ExL’s January Meetings. The group rate is available until January 5. Please book your room early, as rooms available at this rate are limited.
ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us. ExL Events has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL Events’ reserved guest room block using the details provided.
WHO SHOULD ATTEND?This conference is designed for representatives from biotech and pharmaceutical companies with responsibilities in the following areas:
• Risk Safety and REMS Service Providers• Data Management Service Providers• Consultancies• Dashboard and Metrics Service
Providers• Law Firms• Healthcare Information Marketing and
Technology Providers
Sponsorship and Exhibit OpportunitiesDo you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL will work closely with you to customize a package that suits all of your needs.
TERMS AND CONDITIONS: By registering for an ExL Events (“ExL”) event, you agree to the following set of terms and conditions listed below:REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.PAYMENT: Make checks payable to ExL Events and write C853 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to
another ExL event valid for 12 months from the voucher issue date.• Less than four weeks: A voucher to another ExL event valid for 12 months from
the voucher issue date.• Five days or less: A voucher (minus a $395 processing and documentation fee) to
another ExL event valid for 12 months from the voucher issue date.To receive a refund or voucher, please email [email protected] or fax your request to 888-221-6750. CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.
ExL Events does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event.SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants.ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.
To register, call 866-207-6528 or visit http://exlevents.com/REMSTo register, call 866-207-6528 or visit http://exlevents.com/REMS
Thursday, January 26, 2017 | Day One Friday, January 27, 2017 | Day Two Registration Information
8:00 Registration and Continental Breakfast
8:30 Chairperson’s Opening Remarks
8:45 REMS Carousel Discussion Exercise This conversational forum is ideal for sharing and exploring best practices. Each group is assigned a different topic and writes down their collective practices. After 20 minutes they begin a rotation in which they spend 10 minutes reading the recorded practices of the other groups, then add their own. The end product of this activity is a comprehensive digest of participants’ best practices in relation to the following themes: • Communications• Integration• Evaluation/Assessment• Technology/eHealth• Management
9:45 Evaluating REMS Programs for Efficacy and Value• Recognize the role of internal constituencies through the
executive level• Explore best practices in evaluating REMS effectiveness and
analyze the benefits of different assessment methods• Delineate process and compliance metrics• Determine obstacles related to patients’ health literacy, literacy
and demographics to ensure authentic assessments• Develop methods to track progress toward risk minimization
and reduced burdenAnnette Stemhagen, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UNITED BIOSOURCE CORPORATION
10:30 Networking Break
10:45 Apply Shared Treatment Decision-Making Methodologies to REMS to Improve Patient Outcomes • Identify the advantages of benefit-risk counseling• Clarify patient preference and values to determine treatment• Incorporate principles of health outcomes in shared treatment
decisions• Measure the impact of shared decision-making on patient
engagement and outcomes• Highlight strategies for REMS to effect shared decision-makingEmily Freeman, Patient Focused Outcomes Scientist, ELI LILLY
11:30 Panel: Explore the Implications of the FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary• Explore the impact of the FDA’s draft guidance• Inspect the guidance for areas of conflict and ambiguity• Discuss how the guidance impacts sponsors’ submission
strategies• Develop a process for determining the likelihood of a REMSPanelistsDebbie Gash, Director, GPS Benefit Risk Management, ELI LILLYKevin Holman, Senior Director of Drug Regulatory Affairs and REMS Project Leader, ACTELION
12:15 Luncheon
1:15 Create and Submit REMS Documents in a Structured Product Labeling Format• Hear updates and next steps for the FDA’s priority project to use
the Structured Product Labeling (SPL) format to capture REMS• Understand how REMS SPL is structured• Learn the key points of the FDA’s implementation guide• Outline pain points and lessons learned from the REMS SPL pilot• Anticipate the implications of SPL on standardizing and
integrating REMS into the healthcare systemAdam Kroetsch, Operations Research Analyst, FOOD AND DRUG ADMINISTRATION
8:00 Continental Breakfast
8:45 Chairperson’s Recap of Day One
9:00 Support Patients and HCPs with EMC2: A Revolutionary Point of Care Automated Technology• Explore the systemic capabilities of EMC2 (Electronic Health
Record Enabled Medical Complete Communication Strategy) to fit into the prescribers’ workflow
• Support prescribers in counseling patients with medication guides, scripts and simplified information
• Augment patient safety communications with timely, automated prompts and alerts regarding patient understanding, adherence and appropriate medication use
• Analyze the results and lessons learned from the pilot trial for EMC2
• Discuss future steps for implementation and practical issues to consider for a broader EMC2 rollout
Michael Wolf, Professor, Medicine and Learning Sciences Associate Division Chief – Research Division of General Internal Medicine, Feinberg School of Medicine, NORTHWESTERN UNIVERSITYKenneth Hornbuckle, Research Fellow, Global Patient Safety, ELI LILLY
9:45 Alleviate the Burden on Healthcare While Maintaining Due Diligence to Risk Minimization• Summarize the progress of the FDA’s REMS Integration Initiative• Rank factors critical to REMS integration into healthcare
systems• Identify methods to reduce data duplication and discrepancies• Consider the range of healthcare system contexts affected by
REMS• Refine REMS programs using training and certification methods
to alleviate the burden without compromising safetyMolly Billstein Leber, Manager, Medication Policy and Formulary Management, YALE-NEW HAVEN HOSPITAL
10:30 Networking Break
10:45 Panel: Explore Ways to Reduce the Burden of REMS Through Testimonials of a Cross-Section of One Healthcare System• Hear case examples of the burden of REMS from
representatives with disparate roles within one particular healthcare system
• Get tips to hone REMS programs to be more stakeholder-centered
• Integrate into healthcare systems and streamline REMS programs to support patient care
• Discuss REMS programs and components that work and should be replicated
• Explore the role and the potential of allied healthcare professionals
ModeratorThomas Felix, Medical Director, R&D Policy Director, Global Regulatory Affairs and Safety, AMGENPanelistsAdam Bursua, Medication Safety and Quality Coordinator, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCESSYSTEMChris Feld, Registered Nurse, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEMRebekah Hanson, Clinical Pharmacist and Assistant Professor of Pharmacy, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEMScott Wirth, Clinical Pharmacist in Oncology and Clinical Assistant Professor, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM
2:00 Achieve Continuous Improvement of Pharmaceutical Risk Management Through Applied REMS Assessment• Review eight years of REMS assessment data and key
takeaways for benchmarking REMS• Survey collective progress toward using lessons learned to
improve communications• Identify impediments to translating lessons learned into
improved communications and better practices• Examine the role of pharma to mitigate risk beyond the minimal
expectation of REMS compliance• Brainstorm the changes needed for pharma to approach risk
mitigation differentlyLarry Risen, President and CEO, BIOTRAK
2:45 Produce Patient-Centered REMS by Learning from Progress in Patient-Focused Drug Development Initiatives• Discover how evolving patient roles and expectations influence
drug development and regulatory decision-making• Discuss sources and applications of patient input throughout a
drug’s life cycle• Understand how approaches to patient-centered benefit-
risk assessment can inform REMS, surveillance and otherpostmarket processes and practices
• Recognize the contributions of culture and methodology toachieving the promise of patient centricity
Kim McCleary, Managing Director, FASTERCURES
3:30 Networking Break
4:00 Amplify Your Communications with a Supplementary Mobile Phone App• Learn how the American Chronic Pain Association (ACPA) raises
awareness of issues and facilitates education for individualswith chronic pain
• Outline how ACPA’s app communicates essential informationabout all the factors that contribute to one’s level of pain andmedication use in the simplest form possible
• Consider the advantages of an app as an auxiliary medium forconducting surveys
• Walk through the implementation of best practices to drive andmaintain patient behaviors to gain knowledge
Penney Cowan, Founder and President, AMERICAN CHRONIC PAIN ASSOCIATION
4:45 REMS Programs’ Engagement with Technology and Health IT: Past and Present• Examine the evolution of the communication and interaction
methods between REMS administrators and REMS stakeholderssince the Food and Drug Administration Amendments Act
• Evaluate how the existing technological landscape supportsREMS programs
• Discuss current industry initiatives that will influence futureREMS communication and interaction expectations
• Collaborate with key stakeholders to target and improve futureREMS programs’ communication methods
May Chan-Liston, Director, REMS Strategy, CELGENE Paul Sheehan, Senior Director, Risk Management Operations, CELGENE
5:30 Pfizer Case Study: Harmonizing a REMS and an RMP• Receive an overview of the history, status and reach of the
EMA’s Risk Management Plan (RMP)• Compare and contrast legislation, regulatory guidelines and
practical challenges in the US and Europe• Describe lessons learned from risk minimization programs and
evaluations in the US and EU using a Pfizer case study• Summarize the recent EMA workshop on current thinking about
measuring the impact of risk minimization programs and otherpharmacovigilance activities
11:45 Case Study: Examine a Firsthand Account of a Worst Case Scenario• Execute contingency planning inclusive of a wide range of
precedented and unprecedented scenarios• Activate multiple departments early by conveying the cost of not
being prepared• Minimize delays by prioritizing your action plan based on its
complexity and the time necessary to execute• Anticipate internal and external stakeholder reactions in order to
facilitate alignment and authentic collaborationPeter McCroskery, Senior Medical Director, Safety and Benefit Risk, BIOGEN
12:30 Luncheon
1:30 Apply Implementation Science to Design Coherent and Efficient REMS Programs • Avoid pitfalls in designing, implementing and evaluating REMS • Apply key best practices from the field of implementation
science • Uncover the benefits of applying principles of implementation
science through real-world examplesElaine H. Morrato, Associate Dean for Public Health Practice,COLORADO SCHOOL OF PUBLIC HEALTH
2:15 Case Study: Use Data and Benefit-Risk Profiles from Product Development to Inform REMS• Determine the key measurements during clinical studies that
apply to REMS• Translate information from clinical studies to support benefitrisk
counseling and to promote shared treatment decisionmaking• Learn the different structured methods in use to assess benefits
and risksGary Appio, Executive Director Benefit Risk Management Pharmacovigilance, Quality and Safety, JAZZPHARMACEUTICALS
Questions? Comments?Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Conference Production Director Brian Anderson at [email protected].
MEDIA PARTNERS
GROUP DISCOUNT PROGRAMS*Offers may not be combined. Early Bird rates do not apply. To find out more onhow you can take advantage of these group discounts, please call 212-400-6240.*
SAVE 25% For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). This is a savings of 25% per person.
SAVE 15% Can only send three? You can still save 15% off of every registration.
SAVE 25%
SAVE 15%
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"Very engaging speakers with the depth and breadth of knowledge and experience required to comment well on the FDA's standardization report." —US Regulatory Lead, AMGEN
"Excellent, very thought-provoking, eye-opening and informative." —Senior Medical Director, BIOGEN
"This was an excellent meeting bridging academia, industry and government for seeking practical and effective solutions for improving timely risk communication." —Professor, Medicine and Learning Sciences, Associate Division Chief, Feinberg School of Medicine, NORTHWESTERN UNIVERSITY
"Being new to REMS, this conference provided tremendous knowledge and networking opportunities." —Client Services Manager, UCB
TERMS AND CONDITIONS: By registering for an ExL Events (“ExL”) event, you agree to the following set of terms and conditions listed below:REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.PAYMENT: Make checks payable to ExL Events and write C853 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to
another ExL event valid for 12 months from the voucher issue date.• Less than four weeks: A voucher to another ExL event valid for 12 months from
the voucher issue date.• Five days or less: A voucher (minus a $395 processing and documentation fee) to
another ExL event valid for 12 months from the voucher issue date.To receive a refund or voucher, please email [email protected] or fax your request to 888-221-6750. CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.
ExL Events does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event.SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants.ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.
To register, call 866-207-6528 or visit http://exlevents.com/REMSTo register, call 866-207-6528 or visit http://exlevents.com/REMS
Thursday, January 26, 2017 | Day One Friday, January 27, 2017 | Day Two Registration Information
8:00 Registration and Continental Breakfast
8:30 Chairperson’s Opening Remarks
8:45 REMS Carousel Discussion Exercise This conversational forum is ideal for sharing and exploring best practices. Each group is assigned a different topic and writes down their collective practices. After 20 minutes they begin a rotation in which they spend 10 minutes reading the recorded practices of the other groups, then add their own. The end product of this activity is a comprehensive digest of participants’ best practices in relation to the following themes: • Communications • Integration • Evaluation/Assessment • Technology/eHealth • Management
9:45 Evaluating REMS Programs for Efficacy and Value• Recognize the role of internal constituencies through the
executive level• Explore best practices in evaluating REMS effectiveness and
analyze the benefits of different assessment methods• Delineate process and compliance metrics • Determine obstacles related to patients’ health literacy, literacy
and demographics to ensure authentic assessments• Develop methods to track progress toward risk minimization
and reduced burden Annette Stemhagen, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UNITED BIOSOURCE CORPORATION
10:30 Networking Break
10:45 Apply Shared Treatment Decision-Making Methodologies to REMS to Improve Patient Outcomes • Identify the advantages of benefit-risk counseling • Clarify patient preference and values to determine treatment • Incorporate principles of health outcomes in shared treatment
decisions • Measure the impact of shared decision-making on patient
engagement and outcomes • Highlight strategies for REMS to effect shared decision-makingEmily Freeman, Patient Focused Outcomes Scientist, ELI LILLY
11:30 Panel: Explore the Implications of the FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary• Explore the impact of the FDA’s draft guidance• Inspect the guidance for areas of conflict and ambiguity• Discuss how the guidance impacts sponsors’ submission
strategies• Develop a process for determining the likelihood of a REMSPanelistsDebbie Gash, Director, GPS Benefit Risk Management, ELI LILLYKevin Holman, Senior Director of Drug Regulatory Affairs and REMS Project Leader, ACTELION
12:15 Luncheon
1:15 Create and Submit REMS Documents in a Structured Product Labeling Format• Hear updates and next steps for the FDA’s priority project to use
the Structured Product Labeling (SPL) format to capture REMS• Understand how REMS SPL is structured• Learn the key points of the FDA’s implementation guide• Outline pain points and lessons learned from the REMS SPL pilot• Anticipate the implications of SPL on standardizing and
integrating REMS into the healthcare systemAdam Kroetsch, Operations Research Analyst, FOOD AND DRUG ADMINISTRATION
8:00 Continental Breakfast
8:45 Chairperson’s Recap of Day One
9:00 Support Patients and HCPs with EMC2: A Revolutionary Point of Care Automated Technology• Explore the systemic capabilities of EMC2 (Electronic Health
Record Enabled Medical Complete Communication Strategy) tofit into the prescribers’ workflow
• Support prescribers in counseling patients with medicationguides, scripts and simplified information
• Augment patient communications with timely, automated prompts and alerts regarding patient understanding, adherence and appropriate medication use
• Analyze the results and lessons learned from the pilot trialfor EMC2
• Discuss future steps for implementation and practical issues toconsider for a broader EMC2 rollout
Michael Wolf, Professor, Medicine and Learning Sciences Associate Division Chief – Research Division of General Internal Medicine, Feinberg School of Medicine, NORTHWESTERN UNIVERSITYKenneth Hornbuckle, Research Fellow, Global Patient Safety, ELI LILLY
9:45 Alleviate the Burden on Healthcare While Maintaining Due Diligence to Risk Minimization• Summarize the progress of the FDA’s REMS Integration Initiative• Rank factors critical to REMS integration into healthcare
systems• Identify methods to reduce data duplication and discrepancies• Consider the range of healthcare system contexts affected by
REMS• Refine REMS programs using training and certification methods
to alleviate the burden without compromising safetyMolly Billstein Leber, Manager, Medication Policy and Formulary Management, YALE-NEW HAVEN HOSPITAL
10:30 Networking Break
10:45 Panel: Explore Ways to Reduce the Burden of REMS Through Testimonials of a Cross-Section of One Healthcare System• Hear case examples of the burden of REMS from
representatives with disparate roles within one particularhealthcare system
• Get tips to hone REMS programs to be more stakeholder-centered
• Integrate into healthcare systems and streamline REMSprograms to support patient care
• Discuss REMS programs and components that work and shouldbe replicated
• Explore the role and the potential of allied healthcareprofessionals
ModeratorThomas Felix, Medical Director, R&D Policy Director, Global Regulatory Affairs and Safety, AMGENPanelistsAdam Bursua, Medication Safety and Quality Coordinator, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEMChris Feld, Registered Nurse, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM Rebekah Hanson, Clinical Pharmacist and Assistant Professor of Pharmacy, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEMScott Wirth, Clinical Pharmacist in Oncology and Clinical Assistant Professor, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM
2:00 Achieve Continuous Improvement of Pharmaceutical Risk Management Through Applied REMS Assessment• Review eight years of REMS assessment data and key
takeaways for benchmarking REMS • Survey collective progress toward using lessons learned to
improve communications• Identify impediments to translating lessons learned into
improved communications and better practices• Examine the role of pharma to mitigate risk beyond the minimal
expectation of REMS compliance• Brainstorm the changes needed for pharma to approach risk
mitigation differentlyLarry Risen, President and CEO, BIOTRAK
2:45 Produce Patient-Centered REMS by Learning from Progress in Patient-Focused Drug Development Initiatives• Discover how evolving patient roles and expectations influence
drug development and regulatory decision-making• Discuss sources and applications of patient input throughout a
drug’s life cycle• Understand how approaches to patient-centered benefit-
risk assessment can inform REMS, surveillance and other postmarket processes and practices
• Recognize the contributions of culture and methodology to achieving the promise of patient centricity
Kim McCleary, Managing Director, FASTERCURES
3:30 Networking Break
4:00 Amplify Your Communications with a Supplementary Mobile Phone App• Learn how the American Chronic Pain Association (ACPA) raises
awareness of issues and facilitates education for individuals with chronic pain
• Outline how ACPA’s app communicates essential information about all the factors that contribute to one’s level of pain and medication use in the simplest form possible
• Consider the advantages of an app as an auxiliary medium for conducting surveys
• Walk through the implementation of best practices to drive and maintain patient behaviors to gain knowledge
Penney Cowan, Founder and President, AMERICAN CHRONIC PAIN ASSOCIATION
4:45 REMS Programs’ Engagement with Technology and Health IT: Past and Present• Examine the evolution of the communication and interaction
methods between REMS administrators and REMS stakeholders since the Food and Drug Administration Amendments Act
• Evaluate how the existing technological landscape supports REMS programs
• Discuss current industry initiatives that will influence future REMS communication and interaction expectations
• Collaborate with key stakeholders to target and improve future REMS programs’ communication methods
11:45 Case Study: Examine a Firsthand Account of a Worst Case Scenario• Execute contingency planning inclusive of a wide range of
precedented and unprecedented scenarios• Activate multiple departments early by conveying the cost of not
being prepared• Minimize delays by prioritizing your action plan based on its
complexity and the time necessary to execute• Anticipate internal and external stakeholder reactions in order to
facilitate alignment and authentic collaborationPeter McCroskery, Senior Medical Director, Safety and Benefit Risk, BIOGEN
12:30 Luncheon
1:30 Apply Implementation Science to Design Coherent and Efficient REMS Programs • Avoid pitfalls in designing, implementing and evaluating REMS• Apply key best practices from the field of implementation
science• Uncover the benefits of applying principles of implementation
science through real-world examplesElaine H. Morrato, Associate Dean for Public Health Practice, COLORADO SCHOOL OF PUBLIC HEALTH
2:15 Case Study: Use Data and Benefit-Risk Profiles from Product Development to Inform REMS• Determine the key measurements during clinical studies that
apply to REMS• Translate information from clinical studies to support benefitrisk
counseling and to promote shared treatment decisionmaking• Learn the different structured methods in use to assess benefits
and risksGary Appio, Executive Director Benefit Risk Management Pharmacovigilance, Quality and Safety, JAZZ PHARMACEUTICALS
Questions? Comments?Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Conference Production Director Brian Anderson at [email protected].
MEDIA PARTNERS
GROUP DISCOUNT PROGRAMS*Offers may not be combined. Early Bird rates do not apply. To find out more onhow you can take advantage of these group discounts, please call 212-400-6240.*
SAVE 25% For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). This is a savings of 25% per person.
SAVE 15% Can only send three? You can still save 15% off of every registration.
SAVE 25%
SAVE 15%
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"Very engaging speakers with the depth and breadth of knowledge and experience required to comment well on the FDA's standardization report." —US Regulatory Lead, AMGEN
"Excellent, very thought-provoking, eye-opening and informative." —Senior Medical Director, BIOGEN
"This was an excellent meeting bridging academia, industry and government for seeking practical and effective solutions for improving timely risk communication." —Professor, Medicine and Learning Sciences, Associate Division Chief, Feinberg School of Medicine, NORTHWESTERN UNIVERSITY
"Being new to REMS, this conference provided tremendous knowledge and networking opportunities." —Client Services Manager, UCB
TERMS AND CONDITIONS: By registering for an ExL Events (“ExL”) event, you agree to the following set of terms and conditions listed below:REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.PAYMENT: Make checks payable to ExL Events and write C853 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**CANCELLATION AND REFUND POLICY: If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to
another ExL event valid for 12 months from the voucher issue date.• Less than four weeks: A voucher to another ExL event valid for 12 months from
the voucher issue date.• Five days or less: A voucher (minus a $395 processing and documentation fee) to
another ExL event valid for 12 months from the voucher issue date.
CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouchers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.
ExL Events does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event.SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants.ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.
To register, call 866-207-6528 or visit http://exlevents.com/REMSTo register, call 866-207-6528 or visit http://exlevents.com/REMS
Thursday, January 26, 2017 | Day One Friday, January 27, 2017 | Day Two
8:00 Registration and Continental Breakfast
8:30 Chairperson’s Opening Remarks
8:45 REMS Carousel Discussion Exercise This conversational forum is ideal for sharing and exploring best practices. Each group is assigned a different topic and writes down their collective practices. After 20 minutes they begin a rotation in which they spend 10 minutes reading the recorded practices of the other groups, then add their own. The end product of this activity is a comprehensive digest of participants’ best practices in relation to the following themes: • Communications • Integration • Evaluation/Assessment • Technology/eHealth • Management
9:45 Evaluating REMS Programs for Efficacy and Value• Recognize the role of internal constituencies through the
executive level• Explore best practices in evaluating REMS effectiveness and
analyze the benefits of different assessment methods• Delineate process and compliance metrics • Determine obstacles related to patients’ health literacy, literacy
and demographics to ensure authentic assessments• Develop methods to track progress toward risk minimization
and reduced burden Annette Stemhagen, Senior Vice President, Safety, Epidemiology, Registries and Risk Management, UNITED BIOSOURCE CORPORATION
10:30 Networking Break
10:45 Apply Shared Treatment Decision-Making Methodologies to REMS to Improve Patient Outcomes • Identify the advantages of benefit-risk counseling • Clarify patient preference and values to determine treatment • Incorporate principles of health outcomes in shared treatment
decisions • Measure the impact of shared decision-making on patient
engagement and outcomes • Highlight strategies for REMS to effect shared decision-makingEmily Freeman, Patient Focused Outcomes Scientist, ELI LILLY
11:30 Panel: Explore the Implications of the FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary• Explore the impact of the FDA’s draft guidance• Inspect the guidance for areas of conflict and ambiguity• Discuss how the guidance impacts sponsors’ submission
strategies• Develop a process for determining the likelihood of a REMSPanelistsDebbie Gash, Director, GPS Benefit Risk Management, ELI LILLYKevin Holman, Senior Director of Drug Regulatory Affairs and REMS Project Leader, ACTELION
12:15 Luncheon
1:15 Create and Submit REMS Documents in a Structured Product Labeling Format• Hear updates and next steps for the FDA’s priority project to use
the Structured Product Labeling (SPL) format to capture REMS• Understand how REMS SPL is structured• Learn the key points of the FDA’s implementation guide• Outline pain points and lessons learned from the REMS SPL pilot• Anticipate the implications of SPL on standardizing and
integrating REMS into the healthcare systemAdam Kroetsch, Operations Research Analyst, FOOD AND DRUG ADMINISTRATION
8:00 Continental Breakfast
8:45 Chairperson’s Recap of Day One
9:00 Support Patients and HCPs with EMC2: A Revolutionary Point of Care Automated Technology• Explore the systemic capabilities of EMC2 (Electronic Health
Record Enabled Medical Complete Communication Strategy) to fit into the prescribers’ workflow
• Support prescribers in counseling patients with medication guides, scripts and simplified information
• Augment patient safety communications with timely, automated prompts and alerts regarding patient understanding, adherence and appropriate medication use
• Analyze the results and lessons learned from the pilot trial for EMC2
• Discuss future steps for implementation and practical issues to consider for a broader EMC2 rollout
Michael Wolf, Professor, Medicine and Learning Sciences Associate Division Chief – Research Division of General Internal Medicine, Feinberg School of Medicine, NORTHWESTERN UNIVERSITYKenneth Hornbuckle, Research Fellow, Global Patient Safety, ELI LILLY
9:45 Alleviate the Burden on Healthcare While Maintaining Due Diligence to Risk Minimization• Summarize the progress of the FDA’s REMS Integration Initiative• Rank factors critical to REMS integration into healthcare
systems• Identify methods to reduce data duplication and discrepancies• Consider the range of healthcare system contexts affected by
REMS• Refine REMS programs using training and certification methods
to alleviate the burden without compromising safetyMolly Billstein Leber, Manager, Medication Policy and Formulary Management, YALE-NEW HAVEN HOSPITAL
10:30 Networking Break
10:45 Panel: Explore Ways to Reduce the Burden of REMS Through Testimonials of a Cross-Section of One Healthcare System• Hear case examples of the burden of REMS from
representatives with disparate roles within one particular healthcare system
• Get tips to hone REMS programs to be more stakeholder-centered
• Integrate into healthcare systems and streamline REMS programs to support patient care
• Discuss REMS programs and components that work and should be replicated
• Explore the role and the potential of allied healthcare professionals
ModeratorThomas Felix, Medical Director, R&D Policy Director, Global Regulatory Affairs and Safety, AMGENPanelistsAdam Bursua, Medication Safety and Quality Coordinator, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCESSYSTEMChris Feld, Registered Nurse, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEMRebekah Hanson, Clinical Pharmacist and Assistant Professor of Pharmacy, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEMScott Wirth, Clinical Pharmacist in Oncology and Clinical Assistant Professor, UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM
2:00 Achieve Continuous Improvement of Pharmaceutical Risk Management Through Applied REMS Assessment• Review eight years of REMS assessment data and key
takeaways for benchmarking REMS • Survey collective progress toward using lessons learned to
improve communications• Identify impediments to translating lessons learned into
improved communications and better practices• Examine the role of pharma to mitigate risk beyond the minimal
expectation of REMS compliance• Brainstorm the changes needed for pharma to approach risk
mitigation differentlyLarry Risen, President and CEO, BIOTRAK
2:45 Produce Patient-Centered REMS by Learning from Progress in Patient-Focused Drug Development Initiatives• Discover how evolving patient roles and expectations influence
drug development and regulatory decision-making• Discuss sources and applications of patient input throughout a
drug’s life cycle• Understand how approaches to patient-centered benefit-
risk assessment can inform REMS, surveillance and other postmarket processes and practices
• Recognize the contributions of culture and methodology to achieving the promise of patient centricity
Kim McCleary, Managing Director, FASTERCURES
3:30 Networking Break
4:00 Amplify Your Communications with a Supplementary Mobile Phone App• Learn how the American Chronic Pain Association (ACPA) raises
awareness of issues and facilitates education for individuals with chronic pain
• Outline how ACPA’s app communicates essential information about all the factors that contribute to one’s level of pain and medication use in the simplest form possible
• Consider the advantages of an app as an auxiliary medium for conducting surveys
• Walk through the implementation of best practices to drive and maintain patient behaviors to gain knowledge
Penney Cowan, Founder and President, AMERICAN CHRONIC PAIN ASSOCIATION
4:45 REMS Programs’ Engagement with Technology and Health IT: Past and Present• Examine the evolution of the communication and interaction
methods between REMS administrators and REMS stakeholders since the Food and Drug Administration Amendments Act
• Evaluate how the existing technological landscape supports REMS programs
• Discuss current industry initiatives that will influence future REMS communication and interaction expectations
• Collaborate with key stakeholders to target and improve future REMS programs’ communication methods
11:45 Case Study: Examine a Firsthand Account of a Worst Case Scenario• Execute contingency planning inclusive of a wide range of
precedented and unprecedented scenarios• Activate multiple departments early by conveying the cost of not
being prepared• Minimize delays by prioritizing your action plan based on its
complexity and the time necessary to execute• Anticipate internal and external stakeholder reactions in order to
facilitate alignment and authentic collaborationPeter McCroskery, Senior Medical Director, Safety and Benefit Risk, BIOGEN
12:30 Luncheon
1:30 Apply Implementation Science to Design Coherent and Efficient REMS Programs • Avoid pitfalls in designing, implementing and evaluating REMS • Apply key best practices from the field of implementation
science • Uncover the benefits of applying principles of implementation
science through real-world examplesElaine H. Morrato, Associate Dean for Public Health Practice,COLORADO SCHOOL OF PUBLIC HEALTH
2:15 Case Study: Use Data and Benefit-Risk Profiles from Product Development to Inform REMS• Determine the key measurements during clinical studies that
apply to REMS• Translate information from clinical studies to support benefitrisk
counseling and to promote shared treatment decisionmaking• Learn the different structured methods in use to assess benefits
and risksGary Appio, Executive Director Benefit Risk Management Pharmacovigilance, Quality and Safety, JAZZPHARMACEUTICALS
3:00 Chairperson’s Closing Remarks
3:15 Conclusion of Conference
REGISTRATION FEESPricing information for the 9th REMS SummitEARLY BIRD PRICING — Register by December 16, 2016
Questions? Comments?Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email
MEIA PARTNERS
GROUP DISCOUNT PROGRAMS*Offers may not be combined. Early Bird rates do not apply. To find out more on how you can take advantage of these group discounts, please call 212-400-6240.*
SAVE 25% For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). This is a savings of 25% per person.
SAVE 15% Can only send three? You can still save 15% off of every registration.
SAVE 25%
SAVE 15%
PAN
EL
PAN
EL
CASE
STU
DY
CASE
STU
DY
CASE
STU
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36OPMTHE FULL SPECTRUM OF PRODUCT MANAGEMENT
36O
"Very engaging speakers with the depth and breadth of knowledge and experience required to comment well on the FDA's standardization report." —US Regulatory Lead, AMGEN
"Excellent, very thought-provoking, eye-opening and informative." —Senior Medical Director, BIOGEN
"This was an excellent meeting bridging academia, industry and government for seeking practical and effective solutions for improving timely risk communication." —Professor, Medicine and Learning Sciences, Associate Division Chief, Feinberg School of Medicine, NORTHWESTERN UNIVERSITY
"Being new to REMS, this conference provided tremendous knowledge and networking opportunities." —Client Services Manager, UCB
To register, call 866-207-6528 or visit http://exlevents.com/REMSTo register, call 866-207-6528 or visit http://exlevents.com/REMS
SUMMIT
SUMMIT
SUMMIT
SPONSORS
Dear Colleague,
The evolution of REMS engendered numerous innovations, adaptations and best practices suited to address the needs of stakeholders. The 9th REMS Summit will bring together the REMS professional community to propagate the core principles of risk management and to help ensure success. This conference aims to disseminate practices, tools and methods that advance the development of REMS.
We are proud to showcase the industry’s gold standard practices related to integration, shared decision-making, technological tools and evaluation methods. This event provides an environment in which REMS leaders can discuss lessons learned; gain the skills needed to innovate at work; and navigate the production and execution of REMS programs that effectively minimize risk, ensure fidelity to REMS and improve patient outcomes.
In addition to sharing best practices, our skilled faculty members will also explore the burden that REMS programs place on healthcare providers, pharmacists and patients. Stakeholders will expose how REMS can impede care and spotlight model REMS programs worth replicating. As a result, attendees will be able to not only “lesson” the burden of REMS, they will also learn to augment REMS programs to support stakeholders at the point of care.
This summit will provide the latest regulatory REMS and RMP updates related to standardization, integration and Structured Product Labeling. Additionally, attendees willbenefit from an overview of the history of REMS and projections on what is in store for its future and how the Prescription Drug User Fee Act (PDUFA) 6 will impact their work.
I look forward to seeing you in January in Arlington.
Sincerely,
BrianBrian L. AndersonConference Production Director
VENUEHilton Crystal City at Reagan National Airport
2399 Jefferson Davis HwyArlington, VA 22202
Enjoy your stay at this conveniently located hotel in Crystal City, Virginia, only 10 minutes from downtown Washington, DC and adjacent to Ronald Reagan Washington National Airport (DCA). With complimentary shuttle bus service to the Crystal City Metro station and close proximity to shops and restaurants, this hotel is perfectly situated for your next visit to Arlington, VA.
If you require overnight accommodations, please contact the hotel to book your room. ExL has reserved a block of rooms at a group rate for conference participants. To make reservations, guests can call 1-800-695-7551 and request the group rate for ExL’s January Meetings. The group rate is available until January 5. Please book your room early, as rooms available at this rate are limited.
ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at [email protected]. ExL Events has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL Events’ reserved guest room block using the details provided.
WHO SHOULD ATTEND?This conference is designed for representatives from biotech and pharmaceutical companies with responsibilities in the following areas:
• Risk Safety and REMS Service Providers• Data Management Service Providers• Consultancies• Dashboard and Metrics Service
Providers• Law Firms• Healthcare Information Marketing and
Technology Providers
Sponsorship and Exhibit OpportunitiesDo you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL will work closely with you to customize a package that suits all of your needs.
To learn more about these opportunities, contact Alex Siegel at 917-242-3893 or [email protected].
