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

1. RegisteR by JANUARy 14Th foR Reduced PRicing
6th Clinical Data
PROUDLY 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, PA
FEATURED SESSIONS: FEATURED
Determining the Latest EudraCT and European Registry Developments WORkShOP:
Detlef Niese, Head Global Development External Affairs, NOVARTIS
Leveraging Processes
Developing Flexible Global Disclosure Policies and Systems that
Susan Kobza, Senior Manager, Clinical Trials Registry, ASTELLAS
Rosemary Wagner, Global Operations Lead, Clinical Registry Streamline Trial and
JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT Results Transparency
Initiatives
What is the Impact of Sponsor and Affiliate Relationships when Posting
Initiatives Are Not Fully in Sync?
Kristi Whiteside, Clinical Trial Disclosure, CELGENE
Robin Smith, Director Clinical Trial Registries, ALLERGAN
FACUlTy
INClUDES:
Sounding the Alarm: Making Senior Management Understand the
Risks of Data Discrepency and the Impact on Financial and Public Allergan
Stakeholders Astellas
Thomas Wicks, Product Manager, PharmaCM, INTRASPHERE TECHNOLOGIES Astrazeneca
Assessing the Unique Challenges Consumer Products Celgene
Joyce Hauze, MBA, CCRA, Senior Specialist, Clinical Research Operations, Johnson & Johnson
JOHNSON & JOHNSON CONSUMER PRODUCTS Novartis
Evaluating Key Developments in International Transparency Roche Products
Requirements and Registries Taro Pharmaceuticals
John C. McKenney, President, SEC ASSOCIATES
Defining the Impact of Transparency on the Generics Industry SPONSORS AND ExhIbITORS:
Howard Rutman, Vice President, Medical Director, TARO PHARMACEUTICALS
Achieving Cross-Regional Registry Congruency
Christopher Dedels, Global Product Manager – Clinical Trial Disclosure Solutions, VIRTIFY
Implementing a Successful Results Posting Process
Jacqueline Sayers, Quality Projects Manager, ROCHE PRODUCTS
Streamlinining the Results Tabulation Process to Align Reporting Data
Beyond the Project Level
Tania Walton, Principal Programmer, CIS Programming, ASTRAZENECA
To Register Call 866-207-6528 or visit us at www.exlpharma.com

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 Device
environment? What steps can be taken to form a consistent global approach to companies with responsibilities in the
data disclosure, while keeping internal and external stakeholders in sync to the following areas:
information in the public domain?
• Clinical Trial Registration
Pharmaceutical, biologic and device companies are continually challenged
• Trial Results Disclosure
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 • Quality Assurance/Regulatory Affairs
ever-changing policy decisions on if and how they are compliant to the changes • Clinical Development/Compliance
FDAAA has made. • Medical Affairs/Communications
• Consumer Products
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-
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 as
we take a hard look at the implications and present real strategies for complying • Technology solutions for clinical data
with transparency issues today. management
• Consultants in Regulatory and
We look forward to seeing you in Philadelphia. Compliance
• CROs with Registry Posting Services
Sincerely, • Medical Translation Services
• Market Intelligence Services
Terry di Paolo Kristen hunter
Conference Producer Team Leader, Production
Venue 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, 2011
To Register Call 866-207-6528 or visit us at www.exlpharma.com

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 Attendees
MAIN CONFERENCE · DAY ONE · Tuesday, March 1, 2011
12:00 Main Conference Registration Begins 4:00 PANEl DISCUSSION: SPONSORS AND CROS
1:00 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 with
Current Advancements in NIh Rulemaking and Its Impact existing and emerging SOPs
on 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, CELGENE
1:45 EU REgUlATORy Panelists:
Robin Smith, Director Clinical Trial Registries, ALLERGAN
Determining the Latest EudraCT and European Registry
Developments – 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 Registries
Detlef Niese, head Global Development External Affairs Keeping up with the rapid pace of change is a significant challenge for sponsors and investigators
NovARTIS 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 momentum
3:15 SENIOR MANAgEMENT
Sounding the Alarm: Making Senior Management Understand the John C. McKenney, President
Risks of Data Discrepency and the Impact on Financial and Public SEC ASSoCIATES
Stakeholders
• 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 action
Thomas Wicks, Product Manager, PharmaCM
INTRASPhERE TEChNoLoGIES

4. MAIN CONFERENCE · DAY TWO · Wednesday, March 2, 2011
8:00 Continental Breakfast 1:30 glObAl bEST PRACTICES
9:00 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 disclosure
9:05 RESUlTS DISClOSURE • Developing global policies that mitigate local, regional and country-specific regulatory changes
Proactive Strategies in Implementing a Successful Results Posting • Structuring dynamic communications and clear decision paths to ensure specific issues (regitry
Process that Can Anticipate Future Regulatory and Functional rejections, clarifications) are handled efficiently
Challenges 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 STUDY
Jacqueline Sayers, Quality Projects Manager Rosemary Wagner, Global operations Lead, Clinical Registry
RoChE PRoDUCTS JohNSoN & JohNSoN PhARMACEUTICAL RESEARCh &
DEvELoPMENT
9:50 RESUlTS TAbUlATION
Streamlinining the Results Tabulation Process to Align Reporting 3:15 J&J CASE STUDy CONSUMER PRODUCTS
Data 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 environment
11:00 REgISTRy CONgRUENCy
Joyce hauze, MBA, CCRA
Achieving Cross-Regional Registry Congruency in Trial Senior Specialist, Clinical Research operations Contracted with
and 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 Competitive
Christopher Dedels, Global Product Manager – Clinical Trial Intelligence Initiatives and Stakeholder Relations
Disclosure 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 products
11:45 gENERICS INDUSTRy • Evaluating how secondary market services are leveraging posted information through data
Defining the Impact of Transparency on the Generics Industry and mining of ClinicalTrials.gov and reselling to competitors
The 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 PRoDUCTS
TARo PhARMACEUTICALS
howard Rutman, vice President, Medical Director,
TARo PhARMACEUTICALS
12:30 Luncheon for Conference Participants
4:45 Closing Remarks

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(212) 400-6234, sdecker@exlpharma.com
Registration Fees for Attending Exl Pharma’s Media Partners
6th Clinical Data Disclosure Summit:
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register by friday, January 14, 2011 to take advantage of early-bird pricing:
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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 10018
TO 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