•Get an updateontheFDA’sreportregardingevaluationandstandardization

•AddresschallengesandbenefitsinasinglesharedREMSandREMSthatincludeCME

•Analyzemethodstoassesstheeffectivenessofriskmitigationtools•EvaluatedifferencesandsimilaritiesofRMPvs.REMS•LearnaboutinnovativetoolsandstrategiesineHealthtoimproveREMSeffectiveness

•Discussmeaningfulmetricstomeasuretheburden•Understand whatwecanlearnfromotherindustriesregardingriskminimization

•BalanceREMSruleswithCMERules•Hearhowpharmacyorganizationsandhospitalsaremanagingtherisk

•Participate inroundtablestodiscussyourREMSchallengeswithpeers

Hot Topics Include: Pre-Conference Workshop:Best Practices for Regulatory Negotiation and Internal and External AuditsAnthony Faragasso, Independent ConsultantAndrea Stark, Manager QA, GlaxoSmithKline

Enhance your skill set by registering for an All-Access Pass

6th RISK EVALUATION AND MITIGATION STRATEGIES SUMMIT

HishamAbu-Nabaa,Director of Healthcare Systems Engineering Program,LEHIGH UNIVERSITY

MollyBillsteinLeberPharmD,BCPS,Clinical Pharmacy Coordinator,YALE-NEW HAVEN HOSPITAL, INC.

MadalinaChirieac,Medical Director, Safety and Benefit-Risk Management,BIOGEN IDEC

PaulCoplan,Executive Director, Risk Management and Epidemiology,PURDUE PHARMA

MilbhorD’Silva,VP Product Safety and Pharmacovigilance,ASTELLAS

BrianMalkin,Partner,FROMMER LAWRENCE & HAUG LLP

YolaMoridePhD,FISPE,Professor,UNIVERSITÉ DE MONTRÉAL

RachelSobel,Senior Director, Epidemiology,PFIZER

KatieStabi,Drug Information Pharmacist (REMS),CLEVELAND CLINIC

StephenSun,MD,MP,Chief Medical Officer,PARAGONRX

DarrenTucker,Partner,BINGHAM MCCUTCHEN LLP,Former advisor to FTC Commissioners J. Thomas Rosch and Joshua D. Wright

MostafaWali,Senior Director, Risk Management Center of Excellence,SANOFI

MichaelWolf,Professor of Medicine and Learning Sciences, Associate Division Chief,NORTHWESTERN UNIVERSITY, FEINBERG SCHOOL OF MEDICINE

Best Practices for Working Successfully with all Key Stakeholders to Assess Effectiveness and Modify REMS to Reduce the Burden

Join Our Leading Industry Experts:

To Register Call 866–207–6528 or visit www.exlpharma.com/REMS

JANUARY 28–29, 2014 · WESTIN ALEXANDRIA · ALEXANDRIA, VA

Key Areas to be Addressed:STANDARDIZATIONLindsey R. KelleyAssistant Director of Pharmacy, Ambulatory Care ServicesUniversity of Michigan

BURDENGary Appio, PharmD, MBA,Head, US Safety Risk Management,Novartis

EVALUATIONEmily FreemanDirector, Epidemiology, Health Behavior & Program EvaluationPfizer

MODIFICATIONMichael CheungProject Manager in Medical Affairs/Risk ManagementVivus

“This was an excellent meeting bridging academia, industry and government for seeking practical and effective solutions for improving timely risk communication.”

— Michael Wolf, Professor of Medicine and Learning Sciences, Associate Division Chief,

Northwestern University, Feinberg School of Medicine

“

Event Sponsor:

Dear Colleague,WhilesignificantadvanceshavebeenmadeindevelopingandimplementingappropriateREMSelementsforspecificdrugproducts,muchworkneedstobedoneinfurtheringthestateofscienceintwoareas:

1. Designing REMS programs on the basis of objective data-led design decisions

2. Evaluating REMS programs in today’s emerging US Healthcare setting

TherecentHHSOIGEvaluationReport,coupledwiththeOIGSemi-annualReporttoCongress(March2013),anchoredtheopportunityforopendiscussion,debate,andinnovativeideasinthisspecializedfield.Together,thesereportsindicatethatFDAlackscomprehensivedatatodeterminewhetherREMSimprovedrugsafety.Consequently,thisprovidesthebasisforfocusedworkinrefiningandenhancingthedesignofREMSprograms,theadequacyandvalidityofconventionalRMtools,themethodologyinselectingfit-for-purposeREMSevaluationcriteriaapri-ori,andtherigorandrobustnessofREMSProgramEvaluation.Asaresultofrecentdevelopments,wearefacedwithanopportunityandachoicetoeither:more pro-actively engage and partner with FDA in designing and evaluating such programs, or accept the status quo.

Atthe6th Risk Evaluation and Mitigation Strategies Summitthemostexpe-riencedprofessionalsfromacrosssectionofsmalltolargecompanies,pharmacyorganizations,hospitals,academiaandgovernmentagenciessharetheirperspec-tives,experiences,andleveragethediscussionsfromtheFDApublicmeetinginJuly2013.The conference provides a platform to take a proactive approach and discuss:

•Recentdevelopmentsandinitiatives•Possibleframeworksforstandardization• Toolsforevaluation•Bestpracticesformodification•Methodstomeasuretheburden• LessonslearnedfromvariousREMSprograms• InnovativeapproachestoimproveREMSeffectiveness•Whatcanbelearnedfromotherindustries• ChallengesworkinginsinglesharedREMS

Thissummitpresentsawell-roundedperspectiveontheOIG’sfindings,globaldevelopmentsandtheimpactontheindustry.Ininteractiveworkshops,paneldiscussions,casestudiesandpresentations,ourexpertspeakerfacultyaddressesmajorissuesandprovidesmethodstoworkmoreeffectivelywithallkeystake-holders.NomatterifREMSveteranorabsolutenewbie,thisconferenceoffersvaluableinsightsonrecentdevelopments,pairedwiththeopportunitytonet-workandsharewithpeerswhathasworkedandwhathasnot.

WelookforwardtoseeingyouinJanuaryatthe6th Risk Evaluation and Mitigation Strategies Summit!

Kai HahnSenior Conference DirectorExL Pharma

Milbhor D'SilvaChairman/VP Product Safety & PharmacovigilanceAstellas

This boot camp is designed for VP’s, Department Heads, Directors and Managers of Medical Device, Pharma and Biotech companies whose responsibilities include:

Who Should Attend

•REMS•RiskManagement•Pharmacovigilance/Surveillance

•Epidemiology/Pharmacoepidemiology

•Pharmacoeconomics•QualityAssurance•Drug/ProductSafety•ClinicalRiskManagement•LifecycleManagement

•RegulatoryAffairs•ClinicalAffairs•ClinicalDataManagement•ClinicalOperations•ClinicalRiskManagementCompliance

•MedicalWriters/Communications

•Marketing•Branding

This conference is also of interest to:•REMS/DrugSafetyServiceProviders

•ContractResearchOrganizations

•DataManagementServices•TechnologyVendors•PharmaceuticalConsultants•DrugSafety&RiskManagementServices

•HealthCareRegulatorsandPolicyMakers

•HealthServicesResearchandAcademics

•LifecycleManagementServices

•SpeakerBureaus

Sponsorship & Exhibiting OpportunitiesDoyouwanttospreadthewordaboutyourorganization’ssolutionsandservicestopotentialclientswhowillbeattendingthisevent?

Takeadvantageoftheopportunitytoexhibit,underwriteaneducationalsession,hostanetworkingevent,ordistributepromotionalitemstoattendees.ExLPharmawillworkcloselywithyoutocustomizeapackagethatwillsuitallofyourneeds.

To learn more about these opportunities, please contact:JeffreyFriedman,Business Development Manager(917)258–5140 · jfriedman@exlpharma.com

VenueThe Westin Alexandria400 Courthouse Square · Alexandria, VA 22314Direct Line: 703–253–8600Reservations: 1–866–837–4210

Ifyourequireovernightaccommodations,pleasecontactTheWestinAlexandriaat1–866–837–4210tobookyourroom.ExLPharmahasreservedablockofroomsatadiscountedrateforconferenceparticipants.PleasementionExL’s January Meetingstotakeadvantageofthediscount.YoumustbookyourroombyJanuary 6, 2014tobeeligibleforthedis-countedrate.Pleasebookyourroomearly,astheroomsavailableatthisratearelimited.

ExL Events, Inc. is not affiliated with any third-party booking agencies, housing bureaus or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrange-ments, please disregard these solicitations and kindly e-mail us at info@exlevents.com

For More Information Call 866–207–6528 · www.exlpharma.com/REMS

Day One · Tuesday · January 28, 2014 · Pre-Conference Workshop

12:30 Registration

1:00 Welcome and Opening Remarks by ChairpersonMilbhor D'Silva,VP Product Safety and Pharmacovigilance,ASTELLAS

1:15 Understand the FDA Report and the Impact on the Industry

•OutliningoftheFDA’sfindingssincethepublicmeetinginJuly2013•Exploretheimplicationsandimpactontheindustry•Outlookondevelopmentsin2014•Assesschangestotheexistingregulations•UnderstandthereallifecycleofaREMSandthedifferentdecisionpointsformodification

•Trendsintheconversationofthedifferentregulatorybodies

Brian Malkin,Partner,FROMMER LAWRENCE & HAUG LLPYola Moride PhD FISP,Professor,UNIVERSITÉ DE MONTRÉAL

2:00 PANEL DISCUSSION · Leverage the Possibilities of Standardization

•Understandthedifferentaspectsofstandardization:Minimizingvariance,improvingqualityandstandardizedapproachesandtools

• Identifywhichaspectscanbestandardized•Discussideasforaframeworksuchastheimplementationoftiers•Developacommonlanguagefortoolsandeffectivenessevaluation(Pregnancyrulesenrollment,certification)

•Developingastandardrepository,whereallREMSprogramslisttheirsub-missiondocuments,asatypeofclearinghouse

Molly Billstein Leber PharmD, BCPS,Clinical Pharmacy Coordinator,YALE-NEW HAVEN HOSPITAL INC.Lindsey R. Kelley,Assistant Director of Pharmacy, Ambulatory Care Services,UNIVERSITY OF MICHIGAN HEALTH SYSTEMMostafa Wali,Senior Director, Risk Management Center of Excellence,SANOFI

2:45 Making Sense of Risk Minimization Evaluation in the US and EU: Pfizer’s Experience with REMS and RMMs

•ComparetheUSFDAandEMAperspectivesonriskminimizationevaluation

•Describingalargepharmaceuticalcompany’sexperience•Outliningchallengesindesigning,executing,andinterpretingtheresultsofREMSandRMMEvaluationprograms

Rachel Sobel,Senior Director, Epidemiology,PFIZER

3:30 Afternoon Networking and Refreshment Break

4:00 Outlining Risk Evaluation and Mitigation Strategies in a Health System

•DescribeinpatientandoutpatientchallengesofREMS•GiveexamplesofhowahealthsystemmanagesREMSrequirements•ProvidepossiblesolutionstohelphealthsystemsmanageREMSrequirements

Katie Stabi,Drug Information Pharmacist (REMS),CLEVELAND CLINIC

4:45 PANEL DISCUSSION · Address the Elephant in the Room: Developing Meaningful Metrics to Measure the Burden

• Identifywhattomeasureandhowtomeasuredirectlyandindirectly

•Assessingburdeninrelationtoeffectiveness•Definingaburdenindifferentorganizations•HowtosetthresholdsinaccordancewiththeFDA•Understandtheresponsibilitiesofallstakeholders•Leverageshareddecisionmaking

Katie Stabi,Drug Information Pharmacist (REMS),CLEVELAND CLINICGary Appio, PharmD, MBA,Head, US Safety Risk Management,NOVARTISMichael Cheung,Project Manager in Medical Affairs/Risk Management,VIVUS

5:30 End of Day One

Day One · Tuesday · January 28, 2014 · Main Conference

8:00 Registration Opens & Continental Breakfast for Workshop Participants

9:00 Pre-Conference Workshop Begins

12:00 Lunch for Workshop Participants

*There will be a 30 minute networking break during this workshop

Best Practices for Regulatory Negotiation and Internal and External Audits

• FDAAdvisoryCommitteemeetingpreparation• Understandthefactorsthatmighttriggeranaudit• Outliningnecessarystepstoprepareforanaudit• Thedo’sanddon’tswhengoingthroughanaudit• Lessonslearnedfromrecentaudits

Anthony Faragasso,Independent ConsultantAndrea Stark,Manager QA,GLAXOSMITHKLINE

For More Information Call 866–207–6528 · www.exlpharma.com/REMS

8:00 Continental Breakfast

8:45 Chairperson's Recap of Day OneMilbhor D'Silva,VP Product Safety and Pharmacovigilance,ASTELLAS

9:00 Antitrust Issues Raised by REMS Programs

•TheelementsofREMSprogramsraisingantitrustconcerns•TheFTCandFDA’spositionsonallegedREMSabuses•Thedutyofbrandedpharmaceuticalcompaniestoassistgeneric

Darren S. Tucker,Partner,BINGHAM MCCUTCHEN LLPFormer advisor to FTC Commissioners J. Thomas Rosch and Joshua D. Wright

9:30 Address Challenges and Opportunities in a Single Shared REMS and REMS that Involve CME

•Reviewapproachesforcollaborativeparticipationagreements•BalanceCMERuleswithREMSrules•DevelopevaluationmetricsforsharedREMSandREMSinvolvingCME

Paul Coplan,Executive Director, Risk Management and Epidemiology,PURDUE PHARMA

10:15 The Evolution of Risk Management Implementation: Science, Systems, and Simplicity

•Assessingscience-basedmethodsforthedesignandevaluationofriskminimizations,includingFMEA(FailureModeandEffectsAnalysis),long-termoutcomemeasurementsandmodeling

•Incorporatingsystemsthinkinginriskmanagementbyincludingpublicstakeholderinput,discovery-todisposalresponsibility,andcorporateswimlaneplanning

•Analyzingthenextphaseofriskmanagementandtheartof“simplisticdesignandimplementation”forbetterpublichealth

•Highlightingobservationsfromotherindustriesanditspotentialapplica-tionstothepharmaceuticalindustry

Stephen Sun, MD, MPH,Chief Medical Officer,PARAGON RX

10:45 Morning Networking and Refreshment Break

11:15 PANEL DISCUSSION · Methods to Assess the Effectiveness of Risk Mitigation Tools

•Dealingwithalackofguidance•Identifyandevaluatetherisksinvolved•Howtoidentifywhichtoolstouse•Targettoolstowardthemostsevererisks•Trackidentifiedrisks

Milbhor D’Silva,VP Product Safety and Pharmacovigilance,ASTELLASYola Moride PhD FISP,Professor,UNIVERSITÉ DE MONTRÉAL

12:00 The Out of Industry Perspective: What Can Be Learned from other Industries with Regards to Risk Evaluation and Minimization

•ExplorehowsuccessfulriskmanagementprinciplesinotherindustriescanbeappliedtotheLifeScienceindustry

•Outliningthebenefitsofchecklistsandhazardanalysiscriticalcontrolpoints

•Reinforcingtherolesofstakeholders•Definingindustry-wideprinciples

Hisham Abu-Nabaa,Director of Healthcare Systems Engineering Program,LEHIGH UNIVERSITY

12:45 Networking Luncheon

1:45 Lessons learned from Biogen Idec Tysabri REMS Stakeholders Project

The project was designed to collect TOUCH stakeholder data to aid in future modification/improvement of TOUCH and REMS Research objectives focused on:•GainingbetterunderstandingofthelevelofburdenassociatedwithREMS

•AssessingeffectivenessoftoolsandvariouselementsofREMSprograms•AssessingeffectivenessofcommunicationaspectsofREMSprograms•Biogen’srecommendationsforREMSmodificationstriggeredbythere-sultsofthisproject

Madalina Chirieac,Medical Director, Safety and Benefit-Risk Management,BIOGEN IDEC

2:30 PANEL DISCUSSION · Discussing Methods to Evaluate if the REMS is Achieving its Goals

• InnovativestrategiestoevaluateaREMSprogram•Understandtheevidence•Identifywhathasworkedandwhatdidn’t

Lindsey R. Kelley,Assistant Director of Pharmacy, Ambulatory Care Services,UNIVERSITY OF MICHIGAN HEALTH SYSTEMEmily Freeman,Director Epidemiology, Health Behavior & Program Evaluation,PFIZERPaul Coplan,Executive Director, Risk Management and Epidemiology,PURDUE PHARMA

3:15 Afternoon Networking and Refreshment Break

3:45 Highlighting Innovative Tools and Strategies in eHealth to Improve REMS Effectiveness

•EvaluatetheefficiencyofMedguides,CMI,DHCPlettersandemailsasprimeinformationsourceandeducationaltools

•LeveragegamificationandeLearningtoensurebetterresults•Theshifttowardsdigital:anoutlookwhatthefuturewillbring

Michael Wolf,Professor of Medicine and Learning Sciences, Associate Division Chief,NORTHWESTERN UNIVERSITY, FEINBERG SCHOOL OF MEDICINE

4:30 Modifying a REMS to Expand Patient Access: The Qsymia Case Study

•StrategiesusedtobuildtheREMSmodificationproposal•StrategiesusedtooptimizetheREMSmodificationproposalpresentationtoFDA

•MeetingsandnegotiationswithFDA•ImplementingtheapprovedREMSmodification

Michael Cheung,Project Manager in Medical Affairs/Risk Management,VIVUS

5:15 ROUNDTABLE DISCUSSION · Lessons Learned from Various REMS Programs

InthisinteractivesessionyouwillgetachancetodiscussyourREMSpro-gramwithpeersandexchangeviews,findoutwhatworkedandwhatdidn’tworkforothersandlearnhowtheyhavetackledvariouschallenges.

Pleasecomepreparedwithonechallengeyou’dliketodiscuss.

5:45 End of Summit and Closing Remarks

Day Two · Wednesday · January 29, 2014 · Main Conference

5 WAYS TO REGISTER

Group Discount ProgramsOffers cannot be combined, early bird rates do not apply. To find out more on how you can take advantage of these group discounts, call 866–207–6528.

Save 25% Per Person When Registering Four Foreverythreesimultaneousregistrationsfromyourcompany,youwillreceiveafourthcomplimentaryregistrationtotheprogram(must register four at one time).

Save 15% Per Person When Registering Three Canonlysendthree?Youcanstillsave15%offofeachregistration.

PAYMENTMake checks payable to ExL Events, Inc. and write code C453 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.

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CANCELLATION POLICYIf you need to cancel your registration for an upcoming ExL conference, please note the following policies 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 18 months from the voucher issue date.Four weeks or less: A voucher to another ExL event valid for 18 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less.

To receive a refund or voucher, please fax your request to 888–221–6750 or call 212–400–6240.

ExL Pharma reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other costs incurred by registrants. ExL Pharma’s liability is limited to the conference reg-istration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers‚ or venue.

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Registration Fee: The fee includes the conference‚ all program materials‚ and designated continental break-fasts‚ lunches and refreshments.

The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.

The content in ExL slide presentations, including news, data, advertisements and other information, is pro-vided by ExL Events, Inc.’s (“ExL’s”) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposes of copywriting, nor 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, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY THE 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 Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

MEDIA PARTNERS

Registration Information

ExLEvents,Inc.4948thAve,FourthFloorNewYork,NY10001

www.exlpharma.com/REMS

registration@exlpharma.com

866–207–6528

888–221–6750

Registration FeesEarly Bird Pricing

Register by Friday, December 13, 2013Conference & Workshop: $2095Conference Only: $1795

Standard Pricing

Register after Friday, December 13, 2013Conference & Workshop: $2295Conference Only: $1995

Onsite Pricing

Conference & Workshop: $2395Conference Only: $2095

Includes Sales Taxes and Service Fees

“I enjoyed meeting with the other speakers and exchanging ideas regarding REMS and drug safety. Sitting in on the workshops and presentations gave me a wonderful overview of new regulations in the US and the EU. This meeting allowed me to upgrade my knowledge for world wide regs.”

— Anthony Faragasso, Independent Conusltant

“

Tri-located Event

Thiseventwillbetri-locatedwithExLPharma’s4th Annual Developing CAPAs in the GCP Environment and3rd Trial Master File Summit,increasingthenetworkingcapabilitiesandcreatingaterrificonsiteatmosphereforindustryrepresentatives.

Questions? Comments?

Doyouhaveanyquestions,commentsontheprogram,orspecifictopicsyouwouldlikeaddressed?Wouldyouliketogetinvolvedasaspeaker,moderator,ordiscussionleader?PleaseemailtheProgramDirector,KaiHahnatkhahn@exlpharma.com

Key Areas to be Addressed:STANDARDIZATIONLindsey R. KelleyAssistant Director of Pharmacy, Ambulatory Care ServicesUniversity of Michigan

BURDENGary Appio, PharmD, MBA,Head, US Safety Risk Management,Novartis

EVALUATIONEmily FreemanDirector, Epidemiology, Health Behavior & Program EvaluationPfizer

MODIFICATIONMichael CheungProject Manager in Medical Affairs/Risk ManagementVivus

ExLEvents,Inc.4948thAve,FourthFloorNewYork,NY10001

www.exlpharma.com/REMS

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866–207–6528

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6th RISK EVALUATION AND MITIGATION STRATEGIES SUMMIT

Best Practices for Working Successfully with all Key Stakeholders to Assess Effectiveness and Modify REMS to Reduce the Burden

JANUARY 28–29, 2014 · WESTIN ALEXANDRIA · ALEXANDRIA, VA

Event Sponsors: