6th Clinical Data Disclosure Summit, March 2011, Philadelphia

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Implementing and Maintaining Compliant Trial Registries and Results Databases for Drugs, Biologics & Medical Devices

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6th Clinical Data Disclosure Summit, March 2011, Philadelphia

  1. 1. RegisteR by JANUARy 14Th foR Reduced PRicing 6th Clinical DataPROUDLY PRESENTS Disclosure Summit ImplementIng and maIntaInIng ComplIant trIal regIstrIes and results databases for drugs, bIologICs & medICal devICes March 1-2, 2011 Crowne Plaza Philadelphia Downtown · Philadelphia, PAFEATURED SESSIONS: FEATUREDDetermining the Latest EudraCT and European Registry Developments WORkShOP:Detlef Niese, Head Global Development External Affairs, NOVARTIS Leveraging ProcessesDeveloping Flexible Global Disclosure Policies and Systems thatSusan Kobza, Senior Manager, Clinical Trials Registry, ASTELLASRosemary Wagner, Global Operations Lead, Clinical Registry Streamline Trial andJOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT Results Transparency InitiativesWhat is the Impact of Sponsor and Affiliate Relationships when PostingInitiatives Are Not Fully in Sync?Kristi Whiteside, Clinical Trial Disclosure, CELGENERobin Smith, Director Clinical Trial Registries, ALLERGAN FACUlTy INClUDES:Sounding the Alarm: Making Senior Management Understand theRisks of Data Discrepency and the Impact on Financial and Public AllerganStakeholders AstellasThomas Wicks, Product Manager, PharmaCM, INTRASPHERE TECHNOLOGIES AstrazenecaAssessing the Unique Challenges Consumer Products CelgeneJoyce Hauze, MBA, CCRA, Senior Specialist, Clinical Research Operations, Johnson & JohnsonJOHNSON & JOHNSON CONSUMER PRODUCTS NovartisEvaluating Key Developments in International Transparency Roche ProductsRequirements and Registries Taro PharmaceuticalsJohn C. McKenney, President, SEC ASSOCIATESDefining the Impact of Transparency on the Generics Industry SPONSORS AND ExhIbITORS:Howard Rutman, Vice President, Medical Director, TARO PHARMACEUTICALSAchieving Cross-Regional Registry CongruencyChristopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, VIRTIFYImplementing a Successful Results Posting ProcessJacqueline Sayers, Quality Projects Manager, ROCHE PRODUCTSStreamlinining the Results Tabulation Process to Align Reporting DataBeyond the Project LevelTania Walton, Principal Programmer, CIS Programming, ASTRAZENECA To Register Call 866-207-6528 or visit us at www.exlpharma.com
  2. 2. Dear Colleague, Who Should Attend?How can your organization support data disclosure compliance statements Professionals from Pharmaceutical,when posting requirements and processes form a highly non-congruent posting Biotechnology and Medical Deviceenvironment? What steps can be taken to form a consistent global approach to companies with responsibilities in thedata disclosure, while keeping internal and external stakeholders in sync to the following areas:information in the public domain? • Clinical Trial RegistrationPharmaceutical, biologic and device companies are continually challenged • Trial Results Disclosurein keeping up with the nuances of trial registration and results posting require-ments. Consumer Product groups and the generics industry are both caught in • Quality Assurance/Regulatory Affairsever-changing policy decisions on if and how they are compliant to the changes • Clinical Development/ComplianceFDAAA has made. • Medical Affairs/Communications • Consumer ProductsNow in it’s 6th year, ExL Pharma’s 6th Clinical Data Disclosure conference worksto unravel the complexities of posting trial and results information - keeping com- This event is also of interest to:pliant with the myriad of regulatory requirements while keeping your organiza-tion’s communication strategies in sync. Join leading experts and influencers aswe take a hard look at the implications and present real strategies for complying • Technology solutions for clinical datawith transparency issues today. management • Consultants in Regulatory andWe look forward to seeing you in Philadelphia. Compliance • CROs with Registry Posting ServicesSincerely, • Medical Translation Services • Market Intelligence ServicesTerry di Paolo Kristen hunterConference Producer Team Leader, ProductionVenue Information RooM RESERvATIoNS If 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 crowne plaza discount. You must book your room by Monday, February 7, philaDelphia Downtown 2011 to be eligible for the discounted rate. Please book your 1800 Market street room early, as the rooms available at this rate are limited. philadelphia, pa 19103 215-561-7500 For reservations please call 215-561-7500 www.cpphiladelphia.com Discounts enD on MonDay, February 7, 2011To Register Call 866-207-6528 or visit us at www.exlpharma.com
  3. 3. PRE-CONFERENCE WORkShOP · Tuesday, March 1, 2011 Leveraging Processes and Systems that Streamline Trial and Results Transparency Initiatives • Establishing and re-evaluating SOPs to better adjust to the growing complexity of disclosure requirements » Identifying internal and external stakeholders and determining their responsibilities to the gathering, posting and timing of transparency initiatives • Determining the triggers that initiate disclosure actions » 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? • Examining the differnces in trial posting and results posting • Forming processes that best utilize reuse of informational components • Organizing RFP meetings and sourcing stakeholder input to ensure full understanding of process requirements Robin Smith, Director Clinical Trial Registries, ALLERGAN Additional Workshop Leader to be announced 8:00 Workshop Registration and Breakfast 9:00 Workshop Begin 10:30 Networking Break 12:00 Luncheon for Workshop AttendeesMAIN CONFERENCE · DAY ONE · Tuesday, March 1, 201112:00 Main Conference Registration Begins 4:00 PANEl DISCUSSION: SPONSORS AND CROS1:00 Chair’s Welcome and opening Remarks What is the Impact of Sponsor and Affiliate Relationships when Posting Initiatives Are Not Fully in Sync?1:15 NIh RUlEMAkINg • Clarifying the liability present when CROs and affiliates are not fully in sync withCurrent Advancements in NIh Rulemaking and Its Impact existing and emerging SOPson the Expansion of ClinicalTrials.gov • Examining strategies for disseminating posting strategies and requirements when• Providing results for unapproved products from last patient last visitin Phase II trials dealing with multi-national clinical trials• Evaluate the challenges in providing non-technical summaries on trial results • Ensuring that external partner contracts are clear in determining responsibilities• Addressing the impact of providing a copy of full protocol in results disclosure in posting, notifying and maintaining of information• Should the industry report results on discontinued products? Moderator:Scott Cunningham, Partner, CovINGToN & BURLING LLP Kristi Whiteside, Clinical Trial Disclosure, CELGENE1:45 EU REgUlATORy Panelists: Robin Smith, Director Clinical Trial Registries, ALLERGANDetermining the Latest EudraCT and European RegistryDevelopments – Implementing Processes to Ensure Compliance Additional panelist to be announced• 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 4:45 glObAl REgISTRIES• Taking a closer look at Pediatric trials, PIPs and disclosure for studies run inside and out of the Evaluating Key Developments in International Transparency European Union Requirements and RegistriesDetlef Niese, head Global Development External Affairs Keeping up with the rapid pace of change is a significant challenge for sponsors and investigatorsNovARTIS who need to know about newly emerging disclosure requirements in order to remain compliant. This session will help by providing critical information, such as:2:45 Networking and Refreshment Break • 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 momentum3:15 SENIOR MANAgEMENTSounding the Alarm: Making Senior Management Understand the John C. McKenney, PresidentRisks of Data Discrepency and the Impact on Financial and Public SEC ASSoCIATESStakeholders• Understanding what information senior management needs to be presented with to better 5:30 Close of Day One 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 actionThomas Wicks, Product Manager, PharmaCMINTRASPhERE TEChNoLoGIES
  4. 4. MAIN CONFERENCE · DAY TWO · Wednesday, March 2, 20118:00 Continental Breakfast 1:30 glObAl bEST PRACTICES9:00 Chairperson opening Remarks and Roundtable Recaps Developing Flexible Global Disclosure Policies that Form Consistent Approaches to handling Changing Regulatory Requirements • Forming global policies that combine regulatory, stakeholder and internal policy of disclosure9:05 RESUlTS DISClOSURE • Developing global policies that mitigate local, regional and country-specific regulatory changesProactive Strategies in Implementing a Successful Results Posting • Structuring dynamic communications and clear decision paths to ensure specific issues (regitryProcess that Can Anticipate Future Regulatory and Functional rejections, clarifications) are handled efficientlyChallenges ASTELLAS CASE STUDY• Aligning stakeholders and incorporating them into a robust results posting process• Identifying the impact on the wider organization and implementing an effective Susan Kobza, Senior Manager, Clinical Trials Registry communications strategy ASTELLAS• Anticipating future regulatory changes and the impact that may have on your process JOHNSON & JOHNSON CASE STUDYJacqueline Sayers, Quality Projects Manager Rosemary Wagner, Global operations Lead, Clinical RegistryRoChE PRoDUCTS JohNSoN & JohNSoN PhARMACEUTICAL RESEARCh & DEvELoPMENT9:50 RESUlTS TAbUlATIONStreamlinining the Results Tabulation Process to Align Reporting 3:15 J&J CASE STUDy CONSUMER PRODUCTSData Beyond the Project Level Assessing the Unique Challenges Consumer Products Face in• Forming systems that incorporate the intracities in project-specific study data Determining Eligibility, Aligning Stakeholder’s and Posting Trial• Evaluating the tabulation process utilizing SAS macros and Result Information• Overcoming non-specific study level information, such as reasons for discontinuation and free • Evaluating the scope of consumer products and their potential classifications into drug or text study data device categories• Developing oversight protocols that are accurate and consistent across projects within the same • What IS an applicible clinical trial? therapeutic areas » Under which regulation is the trial being conducted?Tania Walton, Principal Programmer, CIS Programming, * Under 21 CFR § 812, 312, 314? Under 402(j) of the PHS Act? Under a 510(k)?ASTRAZENECA * Is it Generally Recognized as Safe and Effective (GRASE) under a Monograph (21 CFR § 330‐358) » The complexities for bioequivalence trials (21 CFR § 320) » What is meant by “with health outcomes”10:30 Networking and Refreshment Break • Adapting SOPs to objectively assess a consumer products requirement to transparency and forming appropriate timing strategies that meet all regulatory and stakeholder requirements • Examining the unique challenges in posting consumer product trial information in an Rx environment11:00 REgISTRy CONgRUENCy Joyce hauze, MBA, CCRAAchieving Cross-Regional Registry Congruency in Trial Senior Specialist, Clinical Research operations Contracted withand Results Posted Data JohNSoN & JohNSoN CoNSUMER AND PERSoNAL PRoDUCTS• Challenges in achieving cross-registry congruency• Systematic approaches to auditing posting data across registries• Synchronizing registry data and overcoming challenges of registry nuances and language barriers 4:00 PANEl: COMPETITIVE INTEllIgENCE• Examining  and evaluating systems that manage trial registration for multiple registries Assessing how Trial Information Impacts CompetitiveChristopher Dedels, Global Product Manager – Clinical Trial Intelligence Initiatives and Stakeholder RelationsDisclosure Solutions, vIRTIFy • 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 products11:45 gENERICS INDUSTRy • Evaluating how secondary market services are leveraging posted information through dataDefining the Impact of Transparency on the Generics Industry and mining of ClinicalTrials.gov and reselling to competitorsThe Unique Challenges to Implementing Trial and Result Policies • Defining predictive analytics and its potential on pipeline development• Defining the types of trials within the generics community that lead to a trigger of disclosure Moderator : requirements• Examining the impact of trial result posting in the highly competitive generics industry Robert Paarlberg, Principal, PAARLBERG & ASSoCIATES » Does posting undermine competitive advantages? Panelists:• Determining best practices in posting data within the generics industry Jacqueline Sayers, Quality Projects Manager,howard Rutman, vice President, Medical Director RoChE PRoDUCTSTARo PhARMACEUTICALS howard Rutman, vice President, Medical Director, TARo PhARMACEUTICALS12:30 Luncheon for Conference Participants 4:45 Closing Remarks
  5. 5. Sponsorship and Exhibiting Opportunities Five Ways to Registerdo you want to spread the word about your organization’s solutions fax: 888-221-6750and services to potential clients who will be attending this event? take mail: exl events, Inc.advantage of the opportunity to exhibit, present an educational session,host a networking event, or distribute promotional items to attendees. 555 8th ave, ste 310exl Pharma will work closely with you to customize a package that will new York, nY 10018suit all of your needs. to learn more about these opportunities, please phone: 866-207-6528contact: online: www.exlpharma.com email: register@exlpharma.comSteve DeckerBusiness Development Manager(212) 400-6234, sdecker@exlpharma.comRegistration Fees for Attending Exl Pharma’s Media Partners6th Clinical Data Disclosure Summit:early birD pricinGregister by friday, January 14, 2011 to take advantage of early-bird pricing:Conference + Workshop $1995Conference only $1695stanDarD pricinGregister after friday, January 14, 2011:Conference + Workshop $2195Conference only $1895onsite pricinGConference + Workshop $2295Conference only $1995Group Discount proGraM:discounts cannot be combined; early Bird rates do not applySave 25% per person when Registering FourFor every three simultaneous registrations from your company, you will receivea 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 ThreeCan only send three? You can still save 15% off of every registration. to findout more on how you can take advantage of these group discounts, please call866-207-6528.Make checks payable to ExL Events, Inc. and write code P1610 on your check. You may also use Visa, MasterCard, Discover or American 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 derivedfrom the Start Date of the event:Four weeks or more: A full refund (minus a $95 processing fee), or a voucher to another ExL event valid for two years from the voucher issue date.Four weeks or Less: A voucher to another ExL event valid for two years from the voucher issue date.To receive a refund or voucher, please fax your request to 888-221-6750.Please Note: Conference registrations may be transferred to other colleagues in the event you are unable to attend. There willbe an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring withinfive business days of any ExL conference.Please notify ExL Pharma, info@exlpharma.com, prior to the event with the name and contact information of the replacement attendee.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, every effort to find a suitable replacement will be made.*The opinions of this faculty do not necessarily reflect those of the companies they represent nor ExL Events, Inc.*
  6. 6. RegisteR by JANUARy 14Th foR Reduced PRicing 6th Clinical Data Disclosure Summit Exp. Date: PROUDLY PRESENTS ImplementIng and maIntaInIng ComplIant trIal regIstrIes and results databases for drugs, bIologICs & medICal devICes PRIORITY CODE: P1610 March 1-2, 2011 PLEASE MENTION Crowne Plaza Philadelphia Downtown Philadelphia, PA FEATURED SESSIONS: FEATURED Determining the Latest EudraCT and European Registry Developments WORkShOP: Detlef Niese, Head Global Development External Affairs, NOVARTIS Leveraging Name on Card Card Number Developing Flexible Global Disclosure Policies Processes and Signature Susan Kobza, Senior Manager, Clinical Trials Registry, ASTELLAS Rosemary Wagner, Global Operations Lead, Clinical Registry Systems that JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT Streamline Trial and Results What is the Impact of Sponsor and Affiliate Relationships when Posting Initiatives Are Not Fully in Sync? Transparency Kristi Whiteside, Clinical Trial Disclosure, CELGENE Initiatives Robin Smith, Director Clinical Trial Registries, ALLERGAN FACUlTy register@exlpharma.com Sounding the Alarm: Making Senior Management Understand the Risks △I wish to receive email updated on ExL Pharma’s upcoming events INClUDES: www.exlpharma.com Zip of Data Discrepency and the Impact on Financial and Public Stakeholders Thomas Wicks, Product Manager, PharmaCM, INTRASPHERE TECHNOLOGIES Allergan 888-221-6750 △I’m interested in marketing opportunities at this event Assessing the Unique Challenges Consumer Products Astellas Joyce Hauze, MBA, CCRA, Senior Specialist, Clinical Research Operations, Astrazeneca JOHNSON & JOHNSON CONSUMER PRODUCTS Celgene State Register Me for the Conference and Workshop Title Fax Johnson & Johnson Yes! Register me for the conference: Evaluating Key Developments in International Transparency Novartis Requirements and Registries Roche Products Register Me for the Conference Only John C. McKenney, President, SEC ASSOCIATES Taro Pharmaceuticals Defining the Impact of Transparency on the Generics Industry Howard Rutman, Vice President, Medical Director, TARO PHARMACEUTICALS SPONSORS AND ExhIbITORS: New York, NY 10018TO R E G I S T E R Achieving Cross-Regional Registry Congruency Please contact me: Christopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, VIRTIFY 555 8th Avenue, ExL Events, Inc. 866-207-6528 Implementing a Successful Results Posting Process Suite 310 Jacqueline Sayers, Quality Projects Manager, ROCHE PRODUCTS Streamlinining the Results Tabulation Process to Align Telephone Reporting Data Beyond the Project Level Company Address Name Tania Walton, Principal Programmer, CIS Programming, ASTRAZENECA Email Dept. City To Register Call 866-207-6528 or visit us at www.exlpharma.com

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