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Transcript of 6th Clinical Data Disclosure Summit, March 2011, Philadelphia
To Register Call 866-207-6528 or visit us at www.exlpharma.com
PROUDLY PRESENTS
6th Clinical Data Disclosure Summit
March 1-2, 2011Crowne Plaza Philadelphia Downtown · Philadelphia, PA
ImplementIng and maIntaInIng ComplIant trIal regIstrIes and results databases for drugs, bIologICs & medICal devICes
FEATURED SESSIONS:
Determining the Latest EudraCT and European Registry DevelopmentsDetlef Niese, Head Global Development External Affairs, NOVARTIS
Developing Flexible Global Disclosure PoliciesSusan Kobza, Senior Manager, Clinical Trials Registry, ASTELLASRosemary Wagner, Global Operations Lead, Clinical RegistryJOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT
What is the Impact of Sponsor and Affiliate Relationships when Posting Initiatives Are Not Fully in Sync?Kristi Whiteside, Clinical Trial Disclosure, CELGENERobin Smith, Director Clinical Trial Registries, ALLERGAN
Sounding the Alarm: Making Senior Management Understand the Risks of Data Discrepency and the Impact on Financial and Public StakeholdersThomas Wicks, Product Manager, PharmaCM, INTRASPHERE TECHNOLOGIES Assessing the Unique Challenges Consumer ProductsJoyce Hauze, MBA, CCRA, Senior Specialist, Clinical Research Operations, JOHNSON & JOHNSON CONSUMER PRODUCTS
Evaluating Key Developments in International Transparency Requirements and RegistriesJohn C. McKenney, President, SEC ASSOCIATES
Defining the Impact of Transparency on the Generics IndustryHoward Rutman, Vice President, Medical Director, TARO PHARMACEUTICALS
Achieving Cross-Regional Registry CongruencyChristopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, VIRTIFY
Implementing a Successful Results Posting ProcessJacqueline Sayers, Quality Projects Manager, ROCHE PRODUCTS
Streamlinining the Results Tabulation Process to Align Reporting Data Beyond the Project LevelTania Walton, Principal Programmer, CIS Programming, ASTRAZENECA
FACUlTy INClUDES:AllerganAstellasAstrazenecaCelgeneJohnson & JohnsonNovartisRoche ProductsTaro Pharmaceuticals
SPONSORS AND ExhIbITORS:
FEATURED WORkShOP:Leveraging Processes and Systems that Streamline Trial and Results Transparency Initiatives
RegisteR by JANUARy 14Th foR Reduced PRicing
Dear Colleague,
How can your organization support data disclosure compliance statements when posting requirements and processes form a highly non-congruent posting environment? What steps can be taken to form a consistent global approach to data disclosure, while keeping internal and external stakeholders in sync to the information in the public domain?
Pharmaceutical, biologic and device companies are continually challenged in keeping up with the nuances of trial registration and results posting require-ments. Consumer Product groups and the generics industry are both caught in ever-changing policy decisions on if and how they are compliant to the changes FDAAA has made.
Now in it’s 6th year, ExL Pharma’s 6th Clinical Data Disclosure conference works to unravel the complexities of posting trial and results information - keeping com-pliant with the myriad of regulatory requirements while keeping your organiza-tion’s communication strategies in sync. Join leading experts and influencers as we take a hard look at the implications and present real strategies for complying with transparency issues today.
We look forward to seeing you in Philadelphia.
Sincerely,
Terry di Paolo Kristen hunterConference Producer Team Leader, Production
Venue Information
Who Should Attend?
Professionals from Pharmaceutical, Biotechnology and Medical Device companies with responsibilities in the following areas:
• Clinical Trial Registration
• Trial Results Disclosure
• Quality Assurance/Regulatory Affairs
• Clinical Development/Compliance
• Medical Affairs/Communications
• Consumer Products
This event is also of interest to:
• Technology solutions for clinical data management
• Consultants in Regulatory and Compliance
• CROs with Registry Posting Services
• Medical Translation Services
• Market Intelligence Services
RooM RESERvATIoNSIf you require overnight accommodations, please contact the Crowne Plaza Philadelphia Downtown at 215-561-7500 to book your room. ExL has reserved a block of rooms at a dis-counted rate for conference participants. Please mention ExL Pharma and the conference name to take advantage of the discount. You must book your room by Monday, February 7, 2011 to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate are limited.
For reservations please call 215-561-7500Discounts enD on MonDay, February 7, 2011
crowne plaza philaDelphia Downtown
1800 Market streetphiladelphia, pa 19103 215-561-7500www.cpphiladelphia.com
To Register Call 866-207-6528 or visit us at www.exlpharma.com
PRE-CONFERENCE WORkShOP · Tuesday, March 1, 2011
MAIN CONFERENCE · DAY ONE · Tuesday, March 1, 201112:00 Main Conference Registration Begins1:00 Chair’s Welcome and opening Remarks
1:15 NIh RUlEMAkINgCurrent Advancements in NIh Rulemaking and Its Impact on the Expansion of ClinicalTrials.gov• Providing results for unapproved products from last patient last visitin Phase II trials• Evaluate the challenges in providing non-technical summaries on trial results• Addressing the impact of providing a copy of full protocol in results disclosure• Should the industry report results on discontinued products?
Scott Cunningham, Partner, CovINGToN & BURLING LLP
1:45 EU REgUlATORyDetermining the Latest EudraCT and European Registry Developments – Implementing Processes to Ensure Compliance• Evaluating the effect EudraCT v8 and pending v9 in ensuring compliance • Assessing how local amendments form unique challenges in the ability to post consistent and uniform information• Taking a closer look at Pediatric trials, PIPs and disclosure for studies run inside and out of the European Union
Detlef Niese, head Global Development External AffairsNovARTIS
2:45 Networking and Refreshment Break
3:15 SENIOR MANAgEMENTSounding the Alarm: Making Senior Management Understand the Risks of Data Discrepency and the Impact on Financial and Public Stakeholders• Understanding what information senior management needs to be presented with to better understand the risks of data discrepancy inherent in posting trial and result information• Evaluating the ramifications of noncompliance of Form 3674s when published articles and registry posting information is seeming inconsistent• Communicating specific gaps in disclosure protocols that require management attention and direction and providing an course of action
Thomas Wicks, Product Manager, PharmaCMINTRASPhERE TEChNoLoGIES
4:00 PANEl DISCUSSION: SPONSORS AND CROSWhat is the Impact of Sponsor and Affiliate Relationships when Posting Initiatives Are Not Fully in Sync?• Clarifying the liability present when CROs and affiliates are not fully in sync with existing and emerging SOPs • Examining strategies for disseminating posting strategies and requirements when dealing with multi-national clinical trials• Ensuring that external partner contracts are clear in determining responsibilities in posting, notifying and maintaining of information
Moderator:Kristi Whiteside, Clinical Trial Disclosure, CELGENEPanelists:Robin Smith, Director Clinical Trial Registries, ALLERGAN
Additional panelist to be announced
4:45 glObAl REgISTRIESEvaluating Key Developments in International Transparency Requirements and RegistriesKeeping up with the rapid pace of change is a significant challenge for sponsors and investigators who need to know about newly emerging disclosure requirements in order to remain compliant. This session will help by providing critical information, such as:• Which countries/regions are most active recently in pushing new requirements• Which registries have been recently launched or are expected soon• Which countries/registries have lost momentum
John C. McKenney, PresidentSEC ASSoCIATES
5:30 Close of Day One
Leveraging Processes and Systems that Streamline Trial and Results Transparency Initiatives
• Establishingandre-evaluatingSOPstobetteradjusttothegrowingcomplexityofdisclosurerequirements» Identifying internal and external stakeholders and determining their responsibilities to the gathering, posting and timing of transparency initiatives
• Determiningthetriggersthatinitiatedisclosureactions» What communications strategy is in place to update trial and site start and status data?» How can we align affiliates, CROs and external partners appropriately?
• Examiningthedifferncesintrialpostingandresultsposting• Formingprocessesthatbestutilizereuseofinformationalcomponents• OrganizingRFPmeetingsandsourcingstakeholderinputtoensurefullunderstandingofprocessrequirementsRobin Smith, Director Clinical Trial Registries, ALLERGANAdditional Workshop Leader to be announced
8:00 Workshop Registration and Breakfast 9:00 Workshop Begin10:30 Networking Break12:00 Luncheon for Workshop Attendees
MAIN CONFERENCE · DAY TWO · Wednesday, March 2, 2011
8:00 Continental Breakfast9:00 Chairperson opening Remarks and Roundtable Recaps
9:05 RESUlTS DISClOSUREProactive Strategies in Implementing a Successful Results Posting Process that Can Anticipate Future Regulatory and Functional Challenges• Aligning stakeholders and incorporating them into a robust results posting process• Identifyingtheimpactonthewiderorganizationandimplementinganeffective communications strategy• Anticipating future regulatory changes and the impact that may have on your process
Jacqueline Sayers, Quality Projects ManagerRoChE PRoDUCTS
9:50 RESUlTS TAbUlATIONStreamlinining the Results Tabulation Process to Align Reporting Data Beyond the Project Level• Formingsystemsthatincorporatetheintracitiesinproject-specificstudydata• EvaluatingthetabulationprocessutilizingSASmacros• Overcoming non-specific study level information, such as reasons for discontinuation and free text study data• Developingoversightprotocolsthatareaccurateandconsistentacrossprojectswithinthesame therapeutic areas
Tania Walton, Principal Programmer, CIS Programming, ASTRAZENECA
10:30 Networking and Refreshment Break
11:00 REgISTRy CONgRUENCyAchieving Cross-Regional Registry Congruency in Trial and Results Posted Data• Challenges in achieving cross-registry congruency• Systematic approaches to auditing posting data across registries• Synchronizingregistrydataandovercomingchallengesofregistrynuancesandlanguagebarriers• Examining and evaluating systems that manage trial registration for multiple registries
Christopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, vIRTIFy
11:45 gENERICS INDUSTRyDefining the Impact of Transparency on the Generics Industry and The Unique Challenges to Implementing Trial and Result Policies • Defining the types of trials within the generics community that lead to a trigger of disclosure requirements• Examining the impact of trial result posting in the highly competitive generics industry
» Does posting undermine competitive advantages?• Determining best practices in posting data within the generics industry
howard Rutman, vice President, Medical DirectorTARo PhARMACEUTICALS
12:30 Luncheon for Conference Participants
1:30 glObAl bEST PRACTICESDeveloping Flexible Global Disclosure Policies that Form Consistent Approaches to handling Changing Regulatory Requirements • Forming global policies that combine regulatory, stakeholder and internal policy of disclosure• Developing global policies that mitigate local, regional and country-specific regulatory changes• Structuring dynamic communications and clear decision paths to ensure specific issues (regitry rejections,clarifications)arehandledefficiently
ASTELLAS CASE STUDY
Susan Kobza, Senior Manager, Clinical Trials RegistryASTELLASJOHNSON & JOHNSON CASE STUDY
Rosemary Wagner, Global operations Lead, Clinical RegistryJohNSoN & JohNSoN PhARMACEUTICAL RESEARCh & DEvELoPMENT
3:15 J&J CASE STUDy CONSUMER PRODUCTSAssessing the Unique Challenges Consumer Products Face in Determining Eligibility, Aligning Stakeholder’s and Posting Trial and Result Information • Evaluating the scope of consumer products and their potential classifications into drug or device categories• What IS an applicible clinical trial?
» Under which regulation is the trial being conducted? * Under21CFR§812,312,314?Under402(j)ofthePHSAct?Undera510(k)?* IsitGenerallyRecognizedasSafeandEffective(GRASE)underaMonograph(21CFR§330‐358)
» Thecomplexitiesforbioequivalencetrials(21CFR§320) » What is meant by “with health outcomes”
• AdaptingSOPstoobjectivelyassessaconsumerproductsrequirementtotransparencyand forming appropriate timing strategies that meet all regulatory and stakeholder requirements• Examining the unique challenges in posting consumer product trial information in an Rx environment
Joyce hauze, MBA, CCRASenior Specialist, Clinical Research operations Contracted withJohNSoN & JohNSoN CoNSUMER AND PERSoNAL PRoDUCTS
4:00 PANEl: COMPETITIVE INTEllIgENCEAssessing how Trial Information Impacts Competitive Intelligence Initiatives and Stakeholder Relations• Implications of results disclosure on pipeline development and wider corporate analysis• Assessing how data, especially results data, can and will be used by other interested parties
» Financial analysts looking to leverage stock spreads » Competitive groups looking to gather information on unapproved products
• Evaluating how secondary market services are leveraging posted information through data mining of ClinicalTrials.gov and reselling to competitors• Defining predictive analytics and its potential on pipeline development
Moderator :
Robert Paarlberg, Principal, PAARLBERG & ASSoCIATESPanelists:
Jacqueline Sayers, Quality Projects Manager, RoChE PRoDUCTShoward Rutman, vice President, Medical Director, TARo PhARMACEUTICALS
4:45 Closing Remarks
Media Partners
Sponsorship and Exhibiting Opportunitiesdo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. exl Pharma will work closely with you to customize a package that will suit all of your needs. to learn more about these opportunities, please contact:
Steve DeckerBusiness Development Manager(212) 400-6234, [email protected]
Registration Fees for Attending Exl Pharma’s 6th Clinical Data Disclosure Summit:
early birD pricinGregister by friday, January 14, 2011 to take advantage of early-bird pricing:Conference + Workshop $1995Conference only $1695
stanDarD pricinGregister after friday, January 14, 2011: Conference + Workshop $2195Conference only $1895
onsite pricinGConference + Workshop $2295Conference only $1995
Group Discount proGraM: discounts cannot be combined; early Bird rates do not apply
Save 25% per person when Registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). this is a savings of 25% per person.
Save 15% per person when Registering Three Can only send three? You can still save 15% off of every registration. to find out more on how you can take advantage of these group discounts, please call 866-207-6528.
MakecheckspayabletoExLEvents, Inc.andwritecodeP1610onyourcheck.YoumayalsouseVisa,MasterCard,DiscoverorAmerican Express. Payments must be received in full prior to the commencement of the conference.Cancellations: If 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: Afullrefund(minusa$95processingfee),oravouchertoanotherExLeventvalidfortwoyearsfromthevoucher issue date.Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date.Toreceivearefundorvoucher,pleasefaxyourrequestto888-221-6750.Please Note: Conference registrations may be transferred to other colleagues in the event you are unable to attend. There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of any ExL conference.
Please notify ExL Pharma, [email protected], prior to the event with the name and contact information of the replacement attendee.PleaseNote:Speakersandagendaaresubjecttochangewithoutnotice.Intheeventofaspeakercancellation,everyefforttofindasuitablereplacementwill be made.
*The opinions of this faculty do not necessarily reflect those of the companies they represent nor ExL Events, Inc.*
Five Ways to Registerfax: 888-221-6750
mail: exl events, Inc.
555 8th ave, ste 310
new York, nY 10018
phone: 866-207-6528
online: www.exlpharma.com
email: [email protected]
To Register C
all 86
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PROUDLY PRESENTS
6th C
linical Data
Disclosure Sum
mit
March 1
-2, 2
011C
rowne Plaza Philadelphia D
owntow
nPhiladelphia, PA
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entIn
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nd
ma
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om
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t trIa
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r d
rug
s, bIo
log
ICs &
med
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l devIC
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FEA
TU
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D S
ESS
ION
S:
Determ
ining the Latest EudraCT and European R
egistry Developm
entsD
etlef Niese, H
ead Global D
evelopment External A
ffairs, NO
VARTIS
Developing Flexible G
lobal Disclosure Policies
Susan Kobza, Senior M
anager, Clinical Trials Registry, ASTELLA
SR
osemary W
agner, Global O
perations Lead, Clinical RegistryJO
HN
SON
& JO
HN
SON
PHA
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AC
EUTICA
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& D
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pact of Sponsor and Affi
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when Posting Initiatives A
re Not Fully in Sync?
Kristi W
hiteside, Clinical Trial Disclosure, C
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obin Smith, D
irector Clinical Trial Registries, ALLERG
AN
Sounding the Alarm
: Making Senior M
anagement U
nderstand the Risks
of Data D
iscrepency and the Impact on Financial and Public Stakeholders
Thomas W
icks, Product Manager, Pharm
aCM
, INTR
ASPH
ERE TEC
HN
OLO
GIES
Assessing the U
nique Challenges C
onsumer Products
Joyce Hauze, M
BA, CC
RA
, Senior Specialist, Clinical Research Operations,
JOH
NSO
N &
JOH
NSO
N CO
NSU
MER PRO
DU
CTS
Evaluating Key D
evelopments in International Transparency
Requirem
ents and Registries
John C. M
cKenney, President, SEC A
SSOC
IATES
Defining the Im
pact of Transparency on the Generics Industry
How
ard Rutm
an, Vice President, M
edical Director, TA
RO PH
AR
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CEU
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Achieving C
ross-Regional R
egistry Congruency
Christopher Dedels, G
lobal Product Manager – Clinical Trial D
isclosure Solutions, VIRTIFY
Implem
enting a Successful Results Posting Process
Jacqueline Sayers, Quality Projects M
anager, ROC
HE PRO
DU
CTS
Streamlinining the R
esults Tabulation Process to Align
Reporting D
ata Beyond the Project Level
Tania Walton, Principal Program
mer, C
IS Programm
ing, ASTR
AZEN
ECA
FAC
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y
INC
lUD
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Allergan
Astellas
Astrazeneca
Celgene
Johnson & Johnson
Novartis
Roche ProductsTaro Pharm
aceuticals
SP
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FEA
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Reg
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NU
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14Th fo
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