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REGISTER AT WWW.CBINET.COM/DISCLOSURE | 800-817-8601 MEDIA PARTNERS: 7th Annual Clinical Data Disclosure,Transparency & Plain Language Summaries Navigate Regulatory Changes, Develop Strategies for Sharing Patient Data and Elevate Medical Writing JANUARY 22-24, 2020 | HYATT REGENCY CORAL GABLES | CORAL GABLES, FL CURATED CONTENT FOR CLINICAL TRIAL SPONSORS DRIVEN BY INDUSTRY EXPERTS AND THOUGHT-LEADERS JOIN US FOR COMPELLING DISCUSSIONS AND CRITICAL INSIGHTS, INCLUDING: Bridge the Gap — Working Together to Enhance Clinical Data Disclosure, Dissemination and Discoverability Hear Critical Insights on Health Canada’s PRCI, EU Policy 0070 and Global Harmonization of Disclosure Regulations Discuss Ethical and Moral Imperatives to Increase Clinical Transparency and Data Sharing in Response to Clear Needs and Expectations from Patients Explore Upcoming Changes in The NIH Review Process and Recommendation for Preparedness Elevate Patient Engagement through Improved Access of Clinical Information FEATURED SPEAKERS FOR THE 2020 PROGRAM INCLUDE: Jo Anne-Marie Blyskal, Head of Global Regulatory Medical Writing & Data Transparency and Disclosure, Teva Richard White, Chief Operating Officer, Oxford PharmaGenesis Deborah Collyar, Founder & President, Patient Advocates in Research (PAIR) Jean-Marc Ferran, Director, Qualiance Jessica S. Scott, M.D., JD, Head of R&D Patient Engagement Office, Takeda Pharmaceutical Company NEW FOR 2020! Customize Your Conference to Meet Your Educational Goals Three Days of Comprehensive Content and Luminary Plenary Conversations Three Targeted Tracks: A. Clinical Disclosure & Anonymization B. Plain Language Summaries C. Regulatory & Medical Writing Nine À La Carte Interactive Breakouts And much more! Brought to you by an informa business CLINICAL & MEDICAL AFF AIRS SERIES

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REGISTER AT WWW.CBINET.COM/DISCLOSURE | 800-817-8601

MEDIA PARTNERS:

7th Annual

Clinical DataDisclosure,Transparency & Plain Language SummariesNavigate Regulatory Changes, Develop Strategies for Sharing Patient Data and Elevate Medical WritingJANUARY 22-24, 2020 | HYATT REGENCY CORAL GABLES | CORAL GABLES, FL

CURATED CONTENT FOR CLINICAL TRIAL SPONSORS DRIVEN BY INDUSTRY EXPERTS AND THOUGHT-LEADERS

JOIN US FOR COMPELLING DISCUSSIONS AND CRITICAL INSIGHTS, INCLUDING:

Bridge the Gap — Working Together to Enhance Clinical Data Disclosure, Dissemination and Discoverability

Hear Critical Insights on Health Canada’s PRCI, EU Policy 0070 and Global Harmonization of Disclosure Regulations

Discuss Ethical and Moral Imperatives to Increase Clinical Transparency and Data Sharing in Response to Clear Needs and Expectations from Patients

Explore Upcoming Changes in The NIH Review Process and Recommendation for Preparedness

Elevate Patient Engagement through Improved Access of Clinical Information

FEATURED SPEAKERS FOR THE 2020 PROGRAM INCLUDE:

Jo Anne-Marie Blyskal,

Head of Global Regulatory Medical Writing & Data

Transparency and Disclosure, Teva

Richard White,

Chief Operating Officer, Oxford PharmaGenesis

Deborah Collyar,

Founder & President, Patient Advocates in

Research (PAIR)

Jean-Marc Ferran,

Director, Qualiance

Jessica S. Scott, M.D., JD,

Head of R&D Patient Engagement Office,

Takeda Pharmaceutical Company

NEW FOR 2020! Customize Your Conference to Meet Your Educational Goals

• Three Days of Comprehensive Content and Luminary Plenary Conversations

• Three Targeted Tracks:A. Clinical Disclosure & AnonymizationB. Plain Language SummariesC. Regulatory & Medical Writing

• Nine À La Carte Interactive Breakouts

• And much more!

Brought to you by

an informa business

CLINICAL & MEDICAL AFFAIRS SERIES

Join us this January in Coral Gables as Informa Connect-CBI’s Clinical Data Disclosure, Transparency & Dissemination Conference celebrates its 7th year and expands content on plain language summaries and medical writing. Driven by audience feedback, this program convenes industry thought leaders and experts to discuss the most pressing issues facing clinical trial transparency and dissemination teams today. Participate in interactive sessions, working groups and strategic discussions to benchmark with peers and elevate your clinical data disclosure operations. Don’t miss your opportunity to join this innovative and growing community and tackle critical challenges impacting your daily work. Benefit from high-level discussions of regulatory developments, strategize to streamline processes and procedures and leverage innovative insights to drive progress within your organization.

PROGRAM DEVELOPMENT & AGENDA QUESTIONS:

Anne Wolfe [email protected] 339-298-2213

SPONSORSHIP & EXHIBIT OPPORTUNITIES:

John Egan [email protected] 339-298-2205

REGISTRATIONS & TEAMS:

Stuart Steller [email protected] 339-298-2158

KEY POINTS OF CONTACT:

OUR CORE AUDIENCE:BIO/PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURERS

also including representatives from:Contract Research Organizations • Universities • Research Institutes • Foundations • Solutions Providers

Clinical Transparency Operations • Documentation & Submissions • Data Transparency/Data Sharing Plain Language/Lay Summaries • Regulatory Affairs • Scientific Reviewer • Patient Engagement • Health Literacy

TITLES NOTED:• Global Regulatory Medical Writing• Lead Science Writer & SME• Scientific Publications• Medical Writer

32%

Medical Writing/ Publications

TITLES NOTED:• Medical Transparency • Disclosure and Transparency• Documentation and Submissions• Plain Language Summaries• Clinical Document Transparency

48%

Disclosure/ Transparency

TITLES NOTED:• Medical Communications• Scientific Communications• Medical Science and Education• Medical Director

TITLES NOTED:• Clinical Science Liaison• Clinical Data Management• Clinical Content Standards• Principal Scientist

Clinical Affairs and Operations

Medical/ Scientific Affairs

13%

AUDIENCE SNAPSHOT:

7%

THANK YOU TO THE 2020 ADVISORY BOARD!

Kelly Coulbourne, Associate Director,

Clinical Trial Data Registries,

Allergan

Julie Holtzople, Director, Clinical

Trial Transparency Operations,

AstraZeneca

Nate Root,

Associate Director Clinical Disclosure and Transparency,

Ionis Pharmaceuticals

Liz Roberts,

Global Public Policy Lead, External

Engagement Practice, UCB

Paul Ngai, M.S.,

Co-founder & Chief Executive Officer,

Xogene

DAY ONE WEDNESDAY, JANUARY 22, 20207:15 Conference Registration and Continental Breakfast

8:15 Conference Chair’s Opening Remarks Iwona Bucior, Director Medical Communications, Myokardia

Delve Into the Evolution of Global Clinical Trial Transparency Regulations

8:30 KEYNOTE ADDRESS Discuss Ethical and Moral Imperatives to Increase Clinical Transparency and Data Sharing in Response to Clear Needs and Expectations from Patients Navigate new scientific initiatives and approaches that benefit patients and the wider community to drive innovation and maximize the fairness and efficiency of medical research.• Review transparency and data-sharing in clinical research

and where the industry can do more• Identify common challenges and opportunities for design,

conduct and dissemination of clinical trial results to reduce the burden of participation

• Discuss how industry can move the needle now to better meet the needs of patients

Jessica S. Scott, M.D., JD, Head of R&D Patient Engagement Office, Takeda Pharmaceutical Company

9:15 Bridge the Gap — Working Together to Enhance Clinical Data Disclosure, Dissemination and DiscoverabilityLearn how collaboration in clinical trial disclosure, medical writing, plain language summaries and broader medical affairs activities can elevate transparency and data dissemination across your organization.• Discuss the evolution of open science and open access as

drivers of clinical trial disclosure and transparency• Explore the impact of the evolving patient-centric landscape

on disclosure activities and the need for plain language summaries across a range of audiences

• Understand how cross-functional teams can work together in driving dissemination and discoverability of clinical data, to ensure that the right people have the right information at the right time

Richard White, Chief Operating Officer, Oxford PharmaGenesis

10:00 Networking and Refreshment Break

10:30 Clinical Document Anonymization and Disclosure, a Global PerspectiveThe session will provide updates on EMA Policy 0070 and Health Canada’s PRCI process.

We will review the status of Policy 0070 in the context of the ever-evolving global landscape of data sharing and discuss:• Policy 0070 status up to the pause• EMA Technical Anonymisation Group (TAG) progresses• Synergies with Health Canada Public Release of Clinical

Information policy• Learnings from the FDA Clinical Data Summary Pilot Program

Jean-Marc Ferran, Director, Qualiance

Health Canada UpdateHear updates, insights and lessons learned from Health Canada’s Public Release of Clinical Information Initiative.

Melissa Jean, Scientific Reviewer – Public Release of Clinical Information, Health Canada

Followed by an Open Q&A Discussion Facilitated by: Sanjay Bagani, Director, Clinical Trials Transparency, Xogene

11:45 Produce Quality Records on ClinicalTrials.gov• Identify common roadblocks to receiving NIH approval

of clinical trial registry submissions and opportunities to proactively overcome them

• Develop a cross-functional approach to align diverse internal and external stakeholders within clinical disclosure and transparency operations

• Leverage robust relationships to elevate the quality of registry data

Laura Troast, MS, Director, Clinical Trial Registration & Results Disclosure, Clinical Data Disclosure & Transparency (CDD&T), Merck & Co., Inc

12:15 Networking Luncheon

TRACK A

CLINICAL DISCLOSURE & ANONYMIZATION

1:30 C H O O S E B E T W E E N O N E O F T H R E E C O N C U R R E N T T R A C K S ( A - C )

TRACK B

PLAIN LANGUAGE SUMMARIES & DISSEMINATION STRATEGIES

TRACK C

REGULATORY & MEDICAL WRITING

1:30 Track Chair's Opening Remarks Oladayo Oyelola, Ph.D., SC (ASCP)

Director, Clinical Trial Information Disclosure Regulatory Management Operations, Daiichi Sankyo, Inc.

1:45 Achieving Balance — Approaching Anonymization with Quantified Risk • Technology has made it possible

to go beyond redaction into risk-based anonymization. Still, sponsors have to exercise discretion

• Explore strategies that achieve balance when enabling sharing, preserving privacy, and operating with the reality of time and resource constraints

Cathal Gallagher, Senior Life Sciences Consultant, d-wise

2:45 Delve into Prospective and Retrospective Analyses of Clinical Disclosure and Data Sharing Requirements• Examine where challenges may

arise in retrospective data requests

• Discuss the potential to proactively approach data sharing with evolving Health Canada requirements

1:30 Track Chair's Opening Remarks Behtash Bahador, MS, Associate

Director, Relationship Management and Development, Center for Information & Study on Clinical Research Participation (CISCRP)

1:45 Delve Into the Complexities of Pediatric Lay Summaries and Determine Best Practices • Understand key differences in

medical writing for pediatric studies

• Examine how to best reach pediatric patients and caregivers

• Include the patient and caregiver perspective in document development

Kelsey Brown, Medical Writing Manager, TransPerfect

2:45 Discover Patient Perspective of Clinical Research and Plain Language Summaries• Understand the patient

perspective on clinical research• Listen to patient feedback on

plain language summaries• Discuss how effective patient

engagement early on helps in creating patient-relevant plain language summaries

Vidhi Vashisht, Associate Director, Kinapse, a Syneos Health Company

1:30 Track Chair's Opening Remarks Jo Anne-Marie Blyskal, Head of Global

Regulatory Medical Writing & Data Transparency and Disclosure, Teva

1:45 Explore Lean Medical Writing and Other Opportunities to Streamline Processes • Define lean medical writing and its

key components• Analyze the benefit of lean writing

vs. other tactical approaches• Examine roadblocks to effective

implementation• Streamline medical writing

processes and operations to ensure optimal resource allocation and reduce costs

Jo Anne-Marie Blyskal, Head of Global Regulatory Medical Writing & Data Transparency and Disclosure, Teva

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MEDICAL WRITING ATTENDEES ARE WELCOME TO ATTEND EITHER OF THE OTHER SESSIONS FROM 2:45-5:00

8:00 Continental Breakfast

8:30 Chair’s Review of Day One Iwona Bucior, Director Medical Communications, Myokardia

8:45 Patient Perspectives on Clinical Data Sharing, Disclosure and DisseminationBenefit from patient perspectives on the evolving landscape for dissemination and disclosure of clinical data and study information. • Discuss common roadblocks to patient access of clinical

information• Understand what is most critical to patients and caregivers

during clinical research• Explore channels and strategies for optimal dissemination • Establish trust through partnerships with patient advocacy

groups and co-development MODERATOR:

Deborah Collyar, Founder & President, Patient Advocates in Research (PAIR)

CONVERSATION CONTRIBUTORS: Jamie Tyrone, CEO and Founder, Beating Alzheimer's By Embracing Science (B.A.B.E.S)

Amy Leitman, Director of Policy & Research, NTM Info & Research

9:30 KEYNOTE ADDRESS Discuss Ethical Standards for Clinical Research and the Responsibilities of the Life Sciences Industry • Review transparency and data-sharing standards in

clinical research• Learn about clinical trial transparency for new drugs and

by large companies as related to the Good Pharma Scorecard• Identify common risk areas and best practices in ethical

design, conduct and dissemination of research Jennifer Miller, Founder, Bioethics International and the Good Pharma

Scorecard; Assistant Professor, Yale University School of Medicine

10:15 Networking and Refreshment Break

10:45 Analyze the Evolution Clinical Disclosure and Transparency and the Potential for Harmonization of Global Standards Examine evolving regulations and requirements related to clinical data disclosure and transparency, including Health Canada’s Public Release of Clinical Information Initiative, ClinicalTrials.gov and EU CTR and Policy 0070.• Compare and contrast the approach of diverse global

regulatory bodies

• Analyze challenges in managing global requirements effectively to improve compliance

• Stay ahead of the curve through streamlined operations and processes

• Explore potential opportunities to harmonize standards and regulations and discuss the future of clinical transparency

MODERATOR: Julie Holtzople, Director, Clinical Trial Transparency Operations, AstraZeneca (Confirmed)

PANELISTS: Nate Root, Associate Director Clinical Disclosure and Transparency, Ionis Pharmaceuticals

Deborah Collyar, Founder & President, Patient Advocates in Research (PAIR)

11:30 Elevate Patient Engagement through Improved Access of Clinical InformationBeyond mere compliance, hear about best practices for making clinical data more accessible to patients, caregivers and other non-HCP stakeholders. • Discuss common barriers to access clinical information,

including health literacy• Improve online functionality to better engage patients,

boosting recruitment and retention • Implement digital strategies to increase patient experience

within clinical websites, making content more relevant and understandable

• Expand the reach of patient-facing materials through innovative portal design and dissemination strategies to relieve burden on trial site staff

MODERATOR: Thomas Wicks, Chief Strategy Officer, TrialScope

PANELISTS: Danielle Leach, Chief of Community and Government Relations, National Brain Tumor Society

Mike Wenger, VP of Patient Engagement, TrialScope

Jo Anne-Marie Blyskal, Head of Global Regulatory Medical Writing & Data Transparency and Disclosure, Teva

12:30 Networking Luncheon

1:45 À La Carte Breakouts and Skills Labs

• Learn about current industry perspectives and how diverse stakeholders view current and potential future clinical data disclosure requirements

Nirpal Virdee, Global Head of Transparency and Disclosure, Synchrogenix, A Certara Company

3:45 Networking and Refreshment Break

4:15 Examine the Evolution of Clinical Disclosure and Transparency in Japan • Hear key lessons learned

from working with Japanese transparency requirements

• Explore the similarities and differences between Japanese and other country-specific/regional requirements

• Discuss common roadblocks in effective disclosure to Japanese regulatory bodies

Jenny Petersen, Director, Alnylam

3:45 Networking and Refreshment Break

4:15 Explore New Technology and Advancements for Clinical Trial Transparency and Health Literacy• Hear how CISCRP is advancing

health literacy and clinical trial transparency, as well as dissemination to patients and caregivers

• Discuss how plain language summaries have evolved and what can be expected to come next

• Benefit from a discussion of case studies and lessons learned

• Benchmark with peers to identify opportunities for improvement

Behtash Bahador, MS, Associate Director, Relationship Management and Development, Center for Information & Study on Clinical Research Participation (CISCRP)

Sudipta Chakraborty, Ph.D., Plain Language Summaries Lead, PRA Health Sciences

NETWORKING, WINE & CHEESE RECEPTION At the Conclusion of the Day One

5:00 Close of Day One

DAY TWO THURSDAY, JANUARY 23, 2020

Case Study

PANEL

PANEL

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1:45 C H O O S E B E T W E E N T H R E E C O N C U R R E N T S E S S I O N S ( 1 - 3 )

Disclosure 1011Explore Advances in Transparency through TransCelerate’s Clinical Research Access Initiative

2Global Harmonization of CTT requirements — Opportunities, Challenges and Ideas

3The first part of this short course serves as part one of an introductory study of data disclosure regulations and transparency requirements for life sciences companies. • NIH Rule for FDAAA• Explore ClinicalTrials.gov and

EudraCT Platforms• Summary of local registries • Understand FDA CSR Pilot Iwona Bucior, Director Medical Communications, Myokardia

Hear an update on the project and understand how registration data quality can be improved by enabling adherence with registry requirements while reflecting key information desired by patients.• Understand the key information patients value

when searching for clinical trials on public registries based on a global patient survey of over 1,000 patients

• Interact to see how sponsors can leverage the free Clinical Trial Registration Tool to proactively evaluate the quality of the clinical trial registration data, specifically for the “Brief Title” and the “Brief Summary” fields, that they submit to government-owned registries

Chris Pfitzer, MA, Transparency Operations Lead, UCB BiosciencesT.J. Sharpe, Speaker, Writer, & Patient Advisor, Starfish Harbor LLC

A Discussion on How to Advance This Global NeedIn this session, come prepared to dig deeper into the current opportunities for global harmonization and share ideas for how to pursue this as an industry.

Julie Holtzople, Director, Clinical Trial Transparency Operations, AstraZeneca Nate Root, Associate Director Clinical Disclosure and Transparency, Ionis Pharmaceuticals

2:45 C H O O S E B E T W E E N T H R E E C O N C U R R E N T S E S S I O N S ( 4 - 6 )

Disclosure 102Advance Disclosure of Biostatistics through Streamlined Programming and Processes

5Analyze Disclosure and Registry Challenges in Socio Behavioral Studies 6

The second part of the short course serves as an introductory study of data disclosure regulations and transparency requirements for life sciences companies and further explores global regulations. • Overview and evolution of EU

Policy 0070 • EU Clinical Trials Registration (CTR)• ICMJE requirements• Introduction to data sharing Oladayo Oyelola, Ph.D., SC (ASCP) Director, Clinical Trial Information Disclosure Regulatory Management Operations, Daiichi Sankyo, Inc.

Hear insights learned from the implementation of new programming techniques to optimize disclosure of clinical biostatistics data.• Discuss common challenges in disseminating

biostatistics• Review current best practices and opportunities

for improvement• Delve into operational and statistical challenges

of effectively communicating this dataPaul Ngai, Co-Founder and CEO, Xogene

• Delve into the specific challenges of working with registries for socio behavioral studies

• Consider opportunities to address common roadblocks in disclosing socio-behavioral data

• Compare and contrast clinical transparency for medical vs. socio behavioral studies

• Exchange best practices and identify areas for continued improvement

Yolanda P. Davis, Clinical Disclosure Manager, University of Miami

3:30 Networking and Refreshment Break

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4:15 C H O O S E B E T W E E N T H R E E C O N C U R R E N T S E S S I O N S ( 7 - 9 )

Changing Processes and Attitudes Towards Risk-assessment and Anonymization after Implementation of Health Canada PRCI

7EMA Policy 0070 — An Exploratory Review of Data Utility in Clinical Study Reports for Academic Research

8Rare Disease Working Group — Explore the Challenges of Disclosure and Transparency in Small Populations

9• HC’s preference for evaluation of

quasi identifiers and reference population for risk-assessment

• Shift in sponsors’ attitude — Moving from qualitative to quantitative risk-assessment

• Preparation before submitting the package to HC

Shalini Dwivedi, Director, Kinapse, a Syneos Health Company

The session will present a review of thirteen secondary-purpose research academic manuscripts based on CSRs and discuss:• How Data Utility is defined in Policy 0070• A classification of the different research

purposes academics are looking to address• Which CSR sections and data entities are

required for their research• Recommendation to optimize and justify Data

Utility in anonymized CSRsJean-Marc Ferran, Director, Qualiance

• Identify and discuss the biggest pain points in disclosure for rare disease professionals

• Benchmark with peers on how to best manage the deidentification of patient-level data

• Analyze ethical roadblocks comply with disclosure and transparency requirements while protecting the patient and furthering science

Nate Root, Associate Director Clinical Disclosure and Transparency, Ionis Pharmaceuticals

NETWORK ING WINE AND CHEESE RECEPT IONAt the Conclusion of Day Two

5:15 Close of Day Two

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DAY THREE FRIDAY, JANUARY 24, 20207:45 Continental Breakfast

8:15 Chairman’s Review of Day Two

Iwona Bucior, Director Medical Communications, Myokardia

8:30 Upcoming Changes in the NIH Review Process and Recommendation for Preparedness• Summary of upcoming changes• Discuss impact on how disclosure arena will change• Recommendations for Sponsors to consider minimum

review rounds Sonali Parmar, Associate Director, Kinapse, a Syneos Health Company

9:15 Research Participant/Patient Perspective of Genetic and Biomarker Disclosure• Hear a Research Participant and her personal journey

of genetic disclosure• Discuss Insights on Disclosure, the Needs of Research

Participants, and Motivations to Volunteer• Understanding Disclosure and Informed Consent• Discuss the Pro's and Con's of Genetic or

Biomarker Disclosure Jamie Tyrone, CEO and Founder,

Beating Alzheimer's By Embracing Science (B.A.B.E.S)

9:45 Explore Effective Ways to Engage with Patients through TransCelerate’s Patient Experience Initiative Hear an update on the Patient Experience initiative and understand how the initiative tools provide more effective ways to engage with patients in the design and execution of clinical studies.• Learn more about the Patient Protocol Engagement

Toolkit (P-PET) and the Study Participant Feedback Questionnaire (SPFQ) toolkits

Sean Ludlam, Clinical Trial Registries, Allergan

10:30 Networking and Refreshment Break

11:00 Partnering with Patients and Participants to Develop Clinical Research Materials and Plain Language Summaries• Identify the opportunities for participant input throughout

the clinical research process• Describe how co-development can elevate document

quality and impact

• Discuss compliance concerns in partnering with patients and advocates to develop participant-facing materials

• Apply best practices to establishing these partnerships • Review case studies and examples of patient and participant

input being integrated into clinical research materials Sylvia Baedorf Kassis, MPH, Program Manager,

Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard

11:45 Elevate the Quality of Clinical Submissions and Documentation through Strategic Medical Writing Delve into opportunities to leverage strategic medical writing to enhance the quality of clinical documentation and accessibility of clinical trial information. • Analyze common risk areas and improve compliance • Identify key metrics for evaluating document quality • Leverage strategic process management to streamline

operations and resource allocation Jo Anne-Marie Blyskal, Head of Global Regulatory Medical Writing &

Data Transparency and Disclosure, Teva Robert Stumpo, Director of Medical Writing and Submission

Management, Teva Pharmaceuticals

12:30 Conference Closing Remarks & Close of Conference

A GREAT PLACE TO MEET YOUR MARKET!Maximize your access to decision-makers and align your brand with the life sciences industry’s premier thought-leaders and industry innovators. Informa Connect-CBI’s custom sponsorship programs are designed to support your organization’s overall business development and marketing

initiatives through meaningful prospect and customer interactions, brand assertion campaigns and content-rich thought-leadership opportunities. Capitalize on the life sciences community’s premier platform for peer-to-peer exchange, solution driven content and first-in-class networking

opportunities. For more information on how to position your company as a sponsor or exhibitor, contact Jamie McHugh at 339-298-2106 or email [email protected].

CONFERENCE SPONSORS:

“Getting updated on guidelines and learning real-life solutions from lively conversations and networking in a smaller venue that allows for more interactions.”— Director, Medical Communications, Myokardia

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CHOOSE YOUR SESSION

Day One Track A B C Day Two 1:30 Session 1 2 3 Day Two 2:30 Session 4 5 6 Day Two 4:00 Session 7 8 9

PRICING ADVANTAGE PRICING RATE Register by 12/13/19

STANDARD RATE

ONSITE RATE

Conference $1999 $2299 $2399

WEBSITEwww.cbinet.com/disclosure

EMAIL [email protected]

PHONE339-298-2158

3 EASY WAYS TO REGISTER

1 2 3

REGISTRATION PC20257

VENUE

Hyatt Regency Coral Gables 50 Alhambra Plaza Coral Gables, FL 33134 Hotel Direct Line: +1-305-441-1234

SUBSTITUTION & CANCELLATION

Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. All cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $499 administrative charge. No refunds will be made after this date; however, the registration fee less the applicable administrative charge can be credited to another Informa Connect-CBI conference if you register within 30 days from the date of this conference to an alternative Informa Connect-CBI conference scheduled within the next six months. In case of conference cancellation, Informa Connect-CBI's liability is limited to refund of the conference registration fee only. Cancellation of a conference due to events beyond our control* are subject to a $499 administrative charge, should you or a colleague be unable to attend the rescheduled date. Informa Connect reserves the right to alter this program without prior notice.

PLEASE NOTE: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or Informa Connect-CBI.

*Events beyond our control include: severe weather conditions, natural and man-made disasters and any other similar events.

ACCOMMODATIONS:

To receive Informa Connect-CBI’s discounted hotel rate online, visit www.cbinet.com/disclosure

BOOK NOW! For hotel room availability and direct booking links, please visit www.cbinet.com/disclosure and select the Venue-Pricing tab. Rooms are limited so please book early. All travel arrangements are subject to availability.

PLEASE NOTE: All hotel reservations for this conference should be booked directly with the hotel. Informa Connect-CBI does not use Housing Bureaus and none are authorized to call on our behalf.

GROUP RATE:

Looking to bring your team? Contact Stuart Steller to learn about potential group savings. Call 339-298-2158 or email [email protected]. * Advantage pricing rates do apply when applicable. Offer may not be combined with any other special pricing promotions. Offer may be used at Informa Connect-CBI co-located events.

SATISFACTION GUARANTEED:

Informa Connect-CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable Informa Connect-CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for Informa Connect-CBI conferences is not required.

*Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)

PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate.

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7th Annual

Clinical DataDisclosure,Transparency & Plain Language SummariesNavigate Regulatory Changes, Develop Strategies for Sharing Patient Data and Elevate Medical WritingJANUARY 22-24, 2020 | HYATT REGENCY CORAL GABLES | CORAL GABLES, FL

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ridg

e the Gap

— W

orking

Tog

ether to E

nhance Clinical

Data D

isclosure, D

isseminatio

n and D

iscoverab

ility

H

ear Critical Insig

hts on H

ealth Canad

a’s PR

CI, E

U P

olicy

00

70 and

Glo

bal H

armo

nization o

f Disclo

sure Reg

ulations

D

iscuss Ethical and

Mo

ral Imp

eratives to Increase C

linical Transp

arency and D

ata Sharing

in Resp

onse to

Clear N

eeds

and E

xpectatio

ns from

Patients

E

xplo

re Up

com

ing C

hanges in T

he NIH

Review

Pro

cess and

Reco

mm

endatio

n for P

repared

ness

E

levate Patient E

ngag

ement thro

ugh Im

pro

ved A

ccess of

Clinical Info

rmatio

n

ANY QUESTIONS OR TO REGISTER CONTACT:

Stuart Steller phone 339-298-2158 email [email protected]

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