The 2010 DIA Annual Meeting Team · CR/CS Shantal Feltham MRS Stiris Research Inc. (519) 471-6211 [email protected] CR/CS Jane Myles MS CR/CR Core Genentech, Inc. (650) 225-4377

June 2009 Dear 2010 Annual Meeting Track Chair, The 46th Annual Meeting Track Chair Resource Guide is provided to you as a reference guide to DIA’s policies related to the development of sessions, speaker recruitment, and overall timeline schedule for the Annual Meeting program. The contents of this guide include 5 tabs that detail the following:

• 2010 Annual Meeting Program Committee Contact List • Track Chair Responsibilities, DIA Policies and Procedures and DIA Volunteer Code of Conduct • 2010 Annual Meeting Program Development Timeline • Guideline Summary for Track and Session Chairperson, Continuing Education Summary, and a

helpful question and answer document describing the purpose of Disclosure Statements • DIA’s Policy Concerning Promotion of Products and Services from the Podium at DIA-Sponsored

Programs While this guide is not inclusive of all information related to the Annual Meeting, we hope that the information provided will guide you as you communicate with your Session Chairs and Speakers that are involved in your Track. Your support in the development of this program, ensuring the quality and standards of the Drug Information Association are implemented are greatly appreciated. We look forward to working with you in the coming months. Sincerely

The 2010 DIA Annual Meeting Team Dr. Gaby L. Danan 46th Annual Meeting Program Chairperson Holly Stevens Maureen Lamplugh Speaker Support Speaker Support [email protected] [email protected] 215.442.6123 215.442.6115 Lori Risboskin Julie Ho Director, Annual Meeting Manager, Annual Meeting Content Development [email protected] [email protected] 215.442.6174 215.442.6179

ROLE FIRST LAST PRE SIAC COMPANY NAME PHONE EMAILProgram Chair Gaby Danan DR CP sanofi-aventis (33) 160495937 [email protected]/Pacific Ling Su DR CR/CR Core Novartis Pharmaceuticals Corporation (86) 13764304386 [email protected] Advisor-Canada Agnes Klein DR Health Canada (613) 954-5706 [email protected] Martin Harvey-Allchurch MR European Medicines Agency, European Union 44 (2074) 188699 [email protected] Kim Quaintance MS FDA (301) 796-0140 [email protected] Topics Stephen Wilson DR ERS/DM/CDM/ST Core FDA (301) 796-0579 [email protected] Tatsuo Kurokawa DR Chiba University (81) 337187515 [email protected] FIRST LAST PRE SIAC COMPANY NAME PHONE EMAILAD John Kamp DR Coalition for Healthcare Communication (202) 719-7216 [email protected] Wayne Pines MR RA APCO Worldwide Inc. (202) 256-5455 [email protected]/IS Ellen Kelso MRS RA Goodwyn IRB (513) 793-8900 x114 [email protected]/IS J. Michael Fitzmaurice MR Agency for Healthcare Research and Quality (301) 427-1227 [email protected] Joy Cavagnaro DR BT Core Access BIO (540) 837-9002 [email protected] Cecil Nick MR PAREXEL Consulting 44 (7740) 899230 [email protected] Teresa Ancukiewicz MS CDM Core Boston Scientific Corporation (508) 683-4516 [email protected] Johann Proeve DR CDM Core Bayer Schering Pharma AG 49 (21) 43051561 [email protected]/GMP Robert Baum DR Pfizer Global R&D (860) 686-4716 [email protected]/GMP Moheb Nasr DR FDA (301) 796-1900 [email protected]

2010 ANNUAL MEETING PROGRAM COMMITTEE as of 05/17/2010Please submit any changes to your contact information to

[email protected]

CMC/GMP Moheb Nasr DR FDA (301) 796-1900 [email protected]/GMP Fritz Erni DR Consultant 41 (79) 3582112 [email protected]/GMP Elaine Morefield DR FDA (301) 796-1987 [email protected] Mariette Boerstoel-Streefland DR CP Core Forest Laboratories Inc. (201) 427-8033 [email protected] William Gregory DR CDM/CP Pfizer Inc (212) 573-7553 [email protected]/CS Shantal Feltham MRS Stiris Research Inc. (519) 471-6211 [email protected]/CS Jane Myles MS CR/CR Core Genentech, Inc. (650) 225-4377 [email protected]/CS Ross Pettit MR CR ARIAD Pharmaceuticals Inc. (617) 621-2241 [email protected] Matthew Rousculp DR EBM Core MedImmune (301) 398-5984 [email protected] Don Rosen MR ERS/IT/MW/CDM GenerationOne (718) 874-9449 [email protected] Stephen Raymond DR Study Endpoints PHT Corporation (617) 973-1610 [email protected]/DM John Aitken DR RA/ERS/MW/DM Core Gilead Sciences (650) 522-1929 [email protected]/DM Kay Bross MS ERS/DM Core Interop, K.Bross Consulting, LLC (513) 489-3840 [email protected] Bruce Wagman MR GCP/QA Covance Inc. (609) 452-4051 [email protected] David Fritsche MR Genzyme Corporation (617) 768-6746 [email protected] Thomas Quinn MR IT The Hollis Group Inc. (610) 889-7350 [email protected] Greg Saltzman MR Fisher BioPharma Services (610) 849-0301 [email protected] William Hahn MR M&S Core Science Branding Communications (877) 724-7472 [email protected] J. Lynn Bass DR Amgen Inc. (843) 271-8144 [email protected] Mary Stewart MS MW H. Lundbeck A/S (45) 4536301311 [email protected] Janet Stoltenborg MRS MW Core AstraZeneca Pharmaceuticals LP (302) 886-7367 [email protected] Paul Brown DR FDA (301) 796-0856 [email protected] Abigail Jacobs DR FDA (301) 796-0174 [email protected] Frank Sistare DR NC Merck & Co., Inc. (215) 652-0043 [email protected]

2010 ANNUAL MEETING PROGRAM COMMITTEE as of 05/17/2010Please submit any changes to your contact information to

[email protected]

NC Frank Sistare DR NC Merck & Co., Inc. (215) 652 0043 [email protected] Pradip Paul DR NHP sanofi-aventis (908) 304-6286 [email protected]

2010 ANNUAL MEETING PROGRAM COMMITTEE as of 05/17/2010Please submit any changes to your contact information to

[email protected]

TRACK FIRST LAST PRE SIAC COMPANY NAME PHONE EMAILOS Solomon Babani MR FI/OS Celtic Pharma Development Services (212) 616-4085 [email protected] Patricia Leuchten MS The Avoca Group Inc. (609) 252-9020 [email protected]/TR Danny Benau DR MW/PETD Core University of the Sciences in Philadelphia (610) 989-9947 [email protected]/TR Carl Metzdorff MR PETD ACES Health Care (32) 2 538 80 82 [email protected]/FI Catherine Ohura MS PM/PM Core Kyowa Hakko Kirin Pharma Inc. (609) 580-7304 [email protected]/FI Raymond Starrett MR PM/PM Core Targacept Inc. (336) 480-2122 [email protected]/FI John Sun DR PM/PM Core Novartis Pharmaceuticals Corporation (862) 778-1952 [email protected]/Law/Corporate Compliance

John Lisman MR RA Core Lisman Legal Life Sciences B.V. (31) 348688564 [email protected]

PP/Law/Corporate Compliance

John Marlow DR NHP Advanstar Communications Inc. (203) 247-7821 [email protected]

PP/Law/Corporate Compliance

Sandra Milligan DR Amgen Inc. (805) 447-7585 [email protected]

RA Roy Baranello MR Consultant (601) 850-3687 [email protected] Cynthia Kirk DR RA CareFusion (314) 645-6600 [email protected] Chin Koerner MRS EBM/IMP Novartis Pharmaceuticals Corporation (301) 468-5607 [email protected] Ian Laws DR GlaxoSmithKline (610) 787-5038 [email protected] Christopher Milne DR RA Tufts University (617) 636-2188 [email protected] Bruce Binkowitz DR Merck & Co., Inc. (732) 594-4402 [email protected] Peiling Yang DR FDA (301) 796-1778 [email protected] Frances Nolan MS VA Medidata Solutions Worldwide (860) 439-1708 [email protected] and Student Poster Co chairs COMPANY NAME PHONE EMAILPoster co-chair James Polli DR University of Maryland School of Pharmacy (410) 706-8292 [email protected] co chair James Polli DR University of Maryland School of Pharmacy (410) 706 8292 [email protected] co-chair Albert Wertheimer DR Temple University (215) 707-1291 [email protected] co-chair Kris Walters DR University of North Carolina Wilmington (910) 962-3640 [email protected] co-chair Barbara Gladson DR University of Medicine and Dentistry of NJ (973) 972-2375 [email protected] Annual Meeting Team TRACKS PHONE EMAIL

Lori Risboskin (215) 442-6174 [email protected] Ho (215) 442-6179 [email protected] Stevens AHC/IS, BT, CR/CS, EBM, GCP, NHP, NC, OS,

PM/FI, PD/TR, RD, ST(215) 442-6123 [email protected]

Maureen Lamplugh AD, CDM, CMC, CSP, EC, ERS/DM, IT, MA, MC, MW, PP, RA, VA

(215) 442-6115 [email protected]

Program DirectorManager, Content Program Development and Speaker Support AssociateProgram Development and Speaker Support Associate

2

Phone +1 215 442 6100 Fax +1 215 442 6199 www.diahome.org

DIA’s 46th Annual Meeting is the biopharmaceutical industry’s largest, longest running, best-value, global, multidisciplinary event.

The DIA Annual Meeting Program Committee is proud to announce the official call for session proposals for the 2010Annual Meeting. There are 25 tracks that define the DIA AnnualMeeting Program. We invite you to submit a session abstract forone of the following interest areas:AHC/IS – Academic Health Centers/Investigative Sites

AD – Advertising

BT – Biotechnology

CMC/GMP – Chemistry, Manufacturing, and Controls/

Good Manufacturing Practices

CDM – Clinical Data Management

CR/CS – Clinical Research and Development/

Clinical Supplies

CP – Clinical Safety and Pharmacovigilance

EC – eClinical

ERS/DM – Electronic Regulatory Submissions/

Document Management

EBM – Evidence-based Medicine

GCP – Good Clinical Practices

IT – Information Technology

MA – Marketing

MC – Medical Communications

MW – Medical/Scientific Writing

NC – Nonclinical Laboratory Safety Assessment

NHP – Natural Health Products

OS – Outsourcing

PD/TR – Professional Development/Training

PM/FI – Project Management/Finance

PP – Public Policy/Law/Corporate Compliance

RA – Regulatory Affairs

RD – R&D Strategy

ST – Statistics

VA – Validation

SESSION ABSTRACT SUBMISSION REQUIREMENTS• Session abstracts must be for a complete 90-minute session.• Only submitted abstracts via DIA’s website will be considered.• As the session abstract author you will be responsible for recruiting at

least two additional speakers representing other companies.• Individual presentation abstracts will not be considered.• The author of the selected abstract will serve as the session chair.• All session chair abstract submitters will be required to complete a speaker

disclosure at the time of submission.– Session Chairperson Disclosure Information

All session chairs and speakers must disclose any significant financialinterest or other relationship with the manufacturer(s) of any commercialproduct(s) and/or providers of commercial services discussed in an edu-cation presentation, as well as any discussion of unlabeled or unapproveddrugs or devices.

Should your session abstract be accepted, the session chair is responsiblefor the following:• Adherence to the DIA policy and procedures regarding session design,

supported speaker and promotion at the podium.(A complete 46th Annual Meeting Program Development Timeline andSession Chair Resource Guide will be provided after session selection iscomplete.)

• Providing complete speaker information to the DIA office no later thanThursday, December 10, 2009.

To submit a session abstract, please visit the DIA websitehttp://www.diahome.org/ DIAHOME/GetInvolved/AbstractSubmissionLauncher.aspx

The following information will be requested at the time of submission:

• Session chairperson name and contact information• Session abstract title• Primary interest area• Subcategory interest area (as needed)• Session Keywords

– Please provide 1 or more keywords to associate with your SessionAbstract. These will be used for search purposes should your abstract beselected as a session concept. Each keyword limited to 100 characters.

• Level of session difficulty• Option to request continuing education credits• Learning objectives (500 characters)• Abstract summary (300 characters)

– This summary will be used to publicize the session within the distributed program.

• Session Abstract Full Description (4000 characters)– This information will be used to determine whether a session based on

your abstract will be included in a DIA program.

Please see page 3 for a complete list of potential topics by Track.Should you have questions regarding your abstract submission, please contact [email protected].

DEADLINE:SEPTEMBER 10, 2009

GUIDELINES FOR SUBMISSION

AHC/IS–Academic Health Centers/

Investigator Sites

The Academic Health Centers/Investigator Sites track will focus on explor-ing and leveraging quality, efficient, research conduct. The objective of thistrack is to provide information supporting growth of research capacity andsuccessful, productive research experiences for investigators/academichealth centers. Topics addressed will be the most current, encouraging androbust perspectives on the operation, conduct and management of clinicalresearch at sites/academic health centers; resources; regulatory require-ments, compliance and oversight; IRBs and human subject protectionresponsibilities; interaction with sponsors and others; risk assessment;investigator-initiated protocols and grants; unanticipated problems; andtraining and education.

AD–Advertising

The topics relate to the advertising and promotion of pharmaceuticals andhow marketing/advertising materials and programs are regulated by regu-latory authorities, including:• FDA enforcement activities • Policies involving CME, off-label uses,DTC advertising, and promotional programs

• Justice Department, US Attorney’sOffices, and OIG activities to pursuefraud and abuse cases

BT–Biotechnology

The biotechnology track will present topics related to discovery and earlydevelopment of novel products including:• Somatic and stem cell therapies:science, ethics, politics

• Quality-by-design, risk-basedapproaches for manufacturingbiotechnology products

• Follow-on and improved biologics;lessons learned for forging a path forward

• Novel vaccine strategies

CMC/GMP–Chemistry, Manufacturing, and

Controls/Good Manufacturing Practices

Abstracts should contribute to the dialogue and discussion on technicaland regulatory issues related to:• Risk-based regulatory oversight • Use of quality risk management(QRM) in pharmaceutical development

• Implementation of real-time releasetesting

• Knowledge management over the

INTEREST AREAS BY TRACKThere are 25 tracks that define the DIA Annual Meeting Program. The following summaries suggest issues andtopics that the program committee would like to have addressed and should serve as a valuable guide as youdevelop your session abstracts.

• Internal company policies relat-ing to compliance with all appli-cable regulations

• Legislative initiatives at the federaland state levels

• Gene therapy – When will thistechnology be a therapeutic reality?

• Oligonucleotide-based therapeu-tics – Clinical validation of thetechnology

• Novel assays, novel manufacturingmethods, novel delivery tech-nologies for biotechnology products

entire pharmaceutical product life cycle from development tocommercialization

• Science and risk-based CMC andGMP initiatives

• Quality-by-design approaches to

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Key to Color CodingGRAY = Advertising/Marketing/Medical

Communications Mega TrackBLUE = Clinical Research Mega Track RED = Information Technology Mega Track

pharmaceutical development• Updates on ICH quality guidancesand FDA’s recent CMC and GMPguidances

• Scientific challenges in technologytransfer from laboratory to pilot to

production scales• Regulatory challenges in globalCMC submissions

• Modern regulatory analyticalmethods and manufacturing controls

CDM–Clinical Data Management

Abstracts should focus on topics triggering discussions among the speak-ers and with the audience. Sessions should cover current challenges inthe area of CDM, addressing controversial topics and those coveringfuture directions CDM may or will take.Suggested topics include:• CDM and interfaces to/interactionswith other functions, like pharma-covigilance, medical affairs, regula-tory affairs, monitoring, study man-agement

• Strategic working relationships withCROs and development partners,challenges, and best practices

• What CDM services exist beyondthe cleaning of databases

• CDM and EHR/EMR case studies• Managerial challenges due tomergers and acquisitions, organiza-tional set up of CDM function,scope of CDM in Pharma, Biotechand CROs

• Global cooperation, addressingrequirements of regions like AsiaPacific, Latin America, EasternEurope, and Africa

CR/CS–Clinical Research/Clinical Supplies

CR abstracts should address:• Managing clinical research in timesof constraint – doing more with less

• Evolving technology in Clinical Re-search management (including socialnetworking e.g. Twitter, Facebook, etc)

• Cracking the globalization code –how to do it smarter, faster, betterwhile still conforming to evolvingregulatory framework

• Transitioning from conservative/tra-ditional methods to an innovativeapproach to conducting clinical trials – who’s doing what?

• Conducting Clinical Trials in a virtual

or semi-virtual environment• Assessing and measuring perform-ance in clinical research – a focuson quality and efficiency

Clinical Supplies abstracts shouldaddress:• Leading-edge technologies toimprove the efficiency and logisticsof the clinical supply chain

• Information technology to stream-line communication between CRand CS

• Procedures to minimize the tradi-tional overage of CS needed to con-duct clinical trials

CP–Clinical Safety and Pharmacovigilance

Clinical Research abstracts should address topics related to:

The practice of clinical safety and pharmacovigilance includes manyopportunities that cover a wide and ever-increasing range that ultimatelyenhances the safe use of products for the patient.The underlying theme of this track will be to assess current opportunitiesand approaches in the optimization of benefits and minimization of risks ofmedicines and medical devices to patients who need these medical inter-ventions. Dialogue and future vision for the protection of patient safety willbe encouraged.Topics include:• New and emerging safety regula-tions, including reports on CIOMSand ICH topics

• Practical aspects of safety datamanagement and safety

databases, and safety sourcing (out-sourcing, offshoring, etc)

• Implications of and solutions to col-laborations between companies(various licensing, co-developmentand co-promotion situations,

Topics include:• Resources and management of stud-ies/personnel

• Compliance to ensure quality dataand integrity of the clinical trialsprocess

• IRBs and human subject protections

• Contracts and budgets• Knowledge of regulatory require-ments and responsibilities

• Management of information andinteractions

4

mergers and acquisitions)• Classification and analysis of safetydata from clinical trials, spontaneoussources, especially in light of nontra-ditional sources like registries, inves-tigator initiated trials, patient supportprograms, e-marketing tools etc.

• Data mining and signal detection• Benefit-risk assessment• Risk management plans and risk

evaluation and mitigation strategies• Risk communication • Integration of pharmacovigilance intothe broader healthcare community

• Implications of electronic healthrecords for prospective and retro-spective pharmacovigilance

• Pharmacoepidemiology• Audits and inspections• Product labeling

EC–eClinical

• Development of technology• Standards, policies and proceduresfor the reporting, capture, analysis,submission

•• Archiving of information createdboth internally and across the

broader healthcare system duringthe process of clinical development

• New proposals and reports ofmethodologies and experienceswith evolving standards and tech-nologies are encouraged

ERS/DM–Electronic Regulatory Submissions/

Document Management

Suggested topics include:• Methods for evidence generationand synthesis for evidence-basedmedicine

• Comparative effectiveness reviews• Systematic reviews and meta-analy-ses for guidelines development

• Pragmatic clinical trials• Health outcomes and health eco-nomics studies

• Medical communication and evi-dence dissemination strategies forevidence-based medicine

This track focuses on current issues related to the generation, systematicevaluation of evidence-based medicines, and impact of medical productson health outcomes, patient-reported outcomes, and health expenditures inclinical practice and drug coverage issues.Examples of clinical guideline development, comparative effectiveness, andthe use of actual case examples are strongly encouraged.

GCP–Good Clinical Practices

Abstracts should address topics related to auditing, domestic and interna-tional GCP, clinical trial disclosure, enterprise quality risk management, andprocess excellence. The quality assurance professional is an importantmember of the clinical trials team, providing regulatory compliance activitiesto prevent and/or resolve issues that may arise during the conduct of a clini-cal trial. Clinical Trial Disclosure professionals provide guidance and activitiesensuring compliance with disclosure of clinical trial protocol and resultsinformation. We strongly encourage thought-provoking session abstracts thatprovide real case studies and examples of practical issue management andissue resolution.

IT–Information Technology

The Information Technology track focuses on the technologies and tech-niques necessary to build and maintain the equipment, software, andskills infrastructure to support our industry. We present a mix of leading-edge research and recent project work within these subject areas.Members and their teams are welcome and encouraged to submit andshare their IT experiences with their colleagues.

MA–Marketing

Abstracts should address the following topics.• Life cycle management• Portfolio analysis/techniques• Market preparation

• Provision of on-label and off-labelinformation

• Response document creation andmaintenance

• Literature evaluation• Contact center issues

• Marketing research• Tactical program implementation

• Innovative technologies• Legal and regulatory aspects ofmedical communications

•• Implementation and technicalissues regarding field-based medical communications

eClinical session abstracts should focus on the following topics:

Session abstracts should address areas of strong interest to attendeesassociated with electronic regulatory submissions. We expect attendanceby electronic regulatory submission development professionals, as well asprofessionals associated with the management of active electronic docu-ment/record collections and archives. Appropriate topics may address oneor more of the following hot-topic areas.• Electronic submissions – impact offormat/process changes

• eLabeling: SPL, PIM, eDRL, PLR –challenges and opportunities

• eSubmission standards:eSignatures, RPS, SDTM, AdaM,SEND – current status and impact

• Global eSubmissions: EU, US,Canada, Japan – regional variations

• eCTD life cycles within and acrossapplications – management in the

real world• Regulatory authority readiness andfuture directions

• eRecords collaboration – The EDMReference Model project

• Managing electronic collections –emerging technologies

• Metadata for Advantage ineCollections

• Content management – enhancingthe user experience

• Enterprise quality risk management:The identification, assessment, andremediation of potential trial relatedrisks

• Process excellence: The role of thequality assurance professional inidentifying, evaluating, and improv-ing trial-related activities

• Global Clinical Trial Disclosure lawand operational issues

• Quality assurance role in vendormanagement programs

•• Global quality assurance manage-ment: Manage locally, think globally

• GCP regulatory authority inspectionpractices and findings

EBM–Evidence-based Medicine

•• Integrating health care and clinicalresearch, including EHR and theimpact of the HITECH legislation.

• Semantics infrastructure to supportinteroperability (Data ElementRepositories, Vocabulary andTerminology Services, BRIDGInformation Model, SemanticWeb...)

• Designing and delivering confiden-

tiality, integrity, availability and inter-operability with Software as aService.

• Identification and development of ITcore competencies, and correspon-ding outsourcing of non-core services.

• Measuring the value of IT in cost-driven times

• Green computing – It’s the environ-ment and our money we’re saving

MC–Medical Communications

Session abstracts should address topics related to the practice and pro-vision of drug or medical information as it relates to internal businesspartners or external customers (including healthcare professionals andconsumers). Topics may include, but are not limited to:

5

NC–Nonclinical Laboratory Safety Assessment

• Strategic regulatory issues andapproaches

• Tactical issues that impact the regulatory process

• The perspective of government regulators

• Political and regulatory environment

• Global legislative initiatives• Pediatric regulatory requirements• Biosimilars• Critical Path• Personalized medicines• FDAAA

Session topics should include drugs and biologics and developments onrecent legislative initiatives concerning emerging therapies, without neglect-ing the field of medical devices and combination products. The track tendsto be 50% “international” by design, so as to reflect the strong globalizationand harmonization trends of today.Perspectives in practical, everyday issues, case studies, innovative approach-es, and challenges of today or tomorrow in the following topics include:

RA–-Regulatory Affairs

Topics include:• Efforts to improve R&D efficiency•• Economics of pharmaceuticaldevelopment

•• How changes in company structureand organization affect performance

• Impact of new regulatory initiatives • External forces that influence indus-trial R&D

• Use of metrics for decision makingat various levels

• Technical and commercial risk inR&D development: Will personal-ized medicines help or hurt?

• Industry-academia collaborationsunder the new conflict-of-interestsscrutiny: How are we managing?

• Translational medicine: Emergentfield or fading fad?

• Are biomarkers streamlining orcomplicating R&D?

This track focuses on strategic issues that relate to R&D performance, theexternal environment, and overall corporate strategy.

RD–R&D Strategy

• Liability• Intellectual property• Legislation (current and future)regarding: approval (authorization),manufacturing, exportation/importa-tion, licensing, prescribing, competi-tion, pricing, and/or reimbursement

• Contracting – suppliers, healthcareprofessionals and CROs

• Ethical issues – research, develop-ment and marketing of medicaland/or complementary medicalproducts

• Corporate compliance

PP–Public Policy/Law/Corporate Compliance

Abstracts should relate to: • Key to new NHP regulatory applica-tions and approvals

• New botanical drug health claims,marketing and registration

• Targeted disease approach

• Safety perspectives in NHP includ-ing how to avoid adulteration toachieve optimal safety

• New dimensions in NHP regulations • Good clinical practices in NHPdevelopment

The natural health products track will represent complex or “poly molecular”products and ingredients from any source.

NHP–Natural Health Products

• Clinical research• Investigative sites• Project management

• Relationship management in clini-cal outsourcing

• Alliance models

OS–Outsourcing

Abstracts should address topics related to the outsourcing of activities inconnection with the drug development process. Session chairs are encour-aged to include the use of case studies of successes (as well as less suc-cessful case studies) with any of these topics.

• Specific application and best prac-tices in the planning, scheduling,execution, risk management, andleadership of drug developmentprojects

• Integrating Project, Portfolio andFinance management in large andsmall organizations – use of PMO’s,enterprise-wide systems, value-driv-en portfolio management, andpractical approaches to budgeting

PM/FI–Project Management/Finance

The PM/FI track is designed to assist Project/Program Managers, PortfolioPlanners, Alliance Managers, Project Leaders, and Finance Managers/asso-ciates stay abreast of the principles, practices, and trends associated withapplied project and portfolio management and financing of drug develop-ment in the Pharmaceutical and Biotechnology industries. In addition, theprogram will consider evolving methods for managing portfolios and get-ting the most out of limited resources, and explore approaches to maximiz-ing the effectiveness of alliances and collaborations across our industry.

These should highlight or focus on: • Global training and educationstrategies

• Career development strategies inthe changing global environment

• eLearning, online training, and distance learning strategies

• Training in multicultural environments• Educating the next generation ofpharmaceutical professionals

Sessions should focus on new, updated, or redesigned ideas and tech-niques that can be applied to the training, education, and development ofpharmaceutical professionals. Models should include novel approaches tolong-standing problems, identification of emerging trends, and ways totake advantage of new technologies to advance the boundaries of tradi-tional training and education.

PD/TR–Professional Development/Training

• Regulatory and immigration issuesrelated to training and education ina global environment

• Leveraging multimedia and Web 2.0in training and education

• Certification issues in training andeducation

• Leveraging training and educationfor career advancement

Topics should relate to issues and concerns in the following areas:

Topics for abstracts include:• New methodologies and experimen-tal techniques and current guidanceon their use in preclearance testing

• ICH updates (S6, S9, M3)• Laboratory studies evaluating phar-macokinetics and effectiveness ofproducts, biomarkers of toxicity, pre-

dictive pharmacology, predictivemodels for preclinical safety, and animal disease models

• Use of non-animal alternatives inpharmaceutical development

• New methods for/ evaluation of/ anintegrated assessment and labelingfor repro/developmental toxicology

The nonclinical laboratory safety assessment track will focus on emergingscientific and regulatory issues related to the assessment of the safety ofregulated products.

and capacity management• Best practices in developing, lead-ing, and enabling high perform-ance teams

• Training, development and accred-itation of Project Managers in theBiopharmaceutical Industry

• Effective partnering/contracting with CROs

• Alliance Management: trends &best practices

Topics include:• ICH E3 guidance• MW competencies• eINDs to eCTDs

• CONSORT Guidelines and AbstractChecklist

• DRM Model and Intelligent Content• Managing the virtual workplace

MW–Medical Writing

The focus of this track will be on sharing experiences and best practices,defining skills required, and the impact of changes in this global environment.

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For the 46th DIA Annual Meeting, several tracks will collaborate to form the following mega tracks:

Advertising/Marketing/Medical Communications Mega TrackClinical Research Mega Track

Information Technology Mega Track

ADVERTISING/MARKETING/MEDICAL COMMUNICATIONSMEGA TRACK

The following tracks are included in the Advertising/Marketing/MedicalMega Track:AD-Advertising

MA-Marketing

MC-Medical Communications

CLINICAL RESEARCH MEGA TRACK The following tracks are included in the Clinical Research Mega Track:AHC/IS-Academic Health Centers/Investigator Sites

CR/CS-Clinical Research and Development/Clinical Supplies

OS-Outsourcing

PM/FI-Project Management/Finance

INFORMATION TECHNOLOGY MEGA TRACKThe following tracks are included in the Information Technology MegaTrack:CDM-Clinical Data Management

EC-eClinical

ERS/DM–Electronic Regulatory Submissions/Document Management

IT-Information Technology

VA–Validation

Topics include:• Impact of new SLC techniques andtechnologies

• Outsourcing• Integration of electronic

Validation abstracts should focus on current, effective, efficient, and qualitymethodologies for computerized system validation (CSV) to ensure compli-ance, data integrity, and quality performance across the GxP spectrum. Weencourage the exploration of the impact of more modern tools and tech-niques on CSV, as well as the CSV challenges introduced by the changingindustry environment.

VA-Validation

medical/health record systems• Data protection/privacy/security• Regulatory expectations• Adoption of DIA PEACH CSV principles

• Design and analysis of multiregionaltrials

• Modeling and trial simulation(including adaptive designs andsample size re-estimation)

• Design of non-inferiority trialsincluding determining the non-inferiority margin

Abstracts should address topics related to the application of statisticsthroughout the entire drug development process. Of special interest areinnovative or novel clinical trial designs (eg, adaptive trials, Bayesian trials,phase II dose-response estimation, Phase II/III trials, and noninferioritytrials), issues surrounding the design and analysis of trials (eg, multiregionaltrials, decision analytic approaches), and issues resulting from the analysesof clinical trials (eg, meta-analyses).

ST–Statistics

• Recent developments in “regulatorystatistics” (eg, ICH guidelines andCPMP Points to Consider)

•• Safety signals• Statistical methods for portfoliooptimization and prioritization ofdrugs in development

Horsham, PA, USA • Basel, Switzerland • Tokyo, Japan • Mumbai, India • Beijing, China

Phone +1 215 442 6100 Fax +1 215 442 6199 www.diahome.org

The DIA Annual Meeting Program Committee recognizes the overwhelmingtask in identifying which track to submit your abstract for consideration.In order to minimize the overlap of similar session topics in different

tracks and promote broader discussion and fuller understanding of topics presented, the Committee has collaborated in forming mega tracks toaddress this issue.

Start the dialogue early and tell your network of contacts about your session at the 46th DIA Annual Meeting.

Press Release We’ve made it easy for you to issue a press release. Just download the speaker press release template and fill in your company information.

46th DIA Annual Meeting Banner Post our meeting banner on your event listings page and link directly to the 46th DIA Annual Meeting website. Just follow these simple steps:

Click here Right click then “save as” to save this banner to your computer Link your banner here You MUST use the following language if you wish to display accompanying text:

[Name] will be speaking at the 46th DIA Annual Meeting (June 13-17, 2010 in Washington, DC.)

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DIA Annual Meeting Track Chair Responsibilities

This document is in addition to the December 2004 DIA Board-approved Annual Meeting Policies and Procedures document. Responsibilities include:

Review previous evaluation summaries and other sources of information toward the goal of improving the track.

Attend all program development meetings and/or teleconferences to ensure consistency and non-overlap of content within this track and offerings in other tracks.

Approve appropriate abstracts and identify topics of interest to DIA’s Annual Meeting audience.

Maintain close working relationship with session chairs and speakers. Implement DIA’s policy on session structure and speaker recruitment. Ensure that session chairs review speaker presentations after they have

been submitted to the EP@C System to confirm that each presentation: o Features the presenter’s company logo only once, on the first slide

of his/her presentation. o Meets the content level criteria designated for the session. o Fits within the written session overview. o Helps meet the learning objectives outlined for the session. o Is non-commercial, objective, fairly balanced and otherwise

adheres to the “DIA Policy Concerning Promotion of Products and Services from the Podium at DIA-Sponsored Programs.”

o Does not overlap with others in the session; if it does, consider modifying whether overlapping presentations to avoid this redundancy.

Adhere to DIA Annual Meeting deadlines and assist DIA in ensuring that all session chairs meet their deadlines.

Drug Information Association

Policies & Procedures

December 1997 Revised May 1998

Revised March 2000 Revised December 2004

Subject: DIA Annual Meeting Discussion: The DIA Annual Meeting is the Association’s worldwide premier event and is also the

North America annual meeting. Given the complexities of such an event, it requires a formal coordination process to ensure continued success. The Annual Meeting is under the aegis of the DIA Board of Directors.

Policy: The Annual Meeting will provide a neutral forum for presentation of information

consistent with the mission of DIA and provide opportunities for expert speakers to interact with attendees to provide value-added information to their professional knowledge base. The Annual Meeting is global in nature and leverages DIA’s unique position as a multi-disciplinary worldwide organization that allows exchange of information between diverse groups.

Roles and Responsibilities Director, North American (NA) Operations

The Director/Department of North America Operations shall be responsible for: • All pre- and onsite logistical matters associated with the annual meeting • All contractual negotiations/agreements in connection with the meeting: e.g. hotel, convention center contractors, vendors and suppliers; exhibition; sub-events • All issues related to communications and marketing plans; scheduling and assignment of sessions; site selection, coordination of sub-events; coordination and content of tutorials; obtaining final approval on selection of keynote speaker; supervision of interdepartmental annual meeting tasks; budget and financial reports, post meeting surveys and evaluation review; providing technology support to the committee, session chairs and speakers • Working with Program Chairperson and Program Committee to ensure that expectations are met in the areas of program quality, content and continuing education

Annual Meeting Chairperson

The Chairperson of the DIA Annual Meeting is approved by the Board of Directors. Chairpersons will be appointed three to five years before the assigned meeting. The DIA Executive Director will solicit names of potential Chairpersons from Board members, former Chairpersons and Office Staff members. The Executive Director will present a list of nominees to the DIA Executive Committee which will select final nominees and present these to the Board for approval at a full Board meeting. The Executive Director will notify those persons who have been approved by the Board.

Responsibilities of Current Chairperson

The current Chairperson is responsible for: • Recommending the Plenary Session keynote speaker to the Director, NA Operations. He/she shall be assisted by the Director, North American Operations in the selection process. A meaningful speaker should be selected for this session and consideration should be given to scientific, medical, political or motivational speakers. In keeping with DIA’s policy of neutrality, no speaker who would likely attempt to persuade the audience towards a particular political, religious or legislative agenda shall be chosen. • Final approval regarding session topics and scheduled time periods related to overlapping sessions • Ensuring that the Program Committee meets it responsibilities and expectations as outlined this policy • Providing a report (see Item #15 in the Expectations section) on the status of the Annual Meeting to the DIA Board of Directors at the December Board Meeting Annual Meeting Coordinating Committee A committee consisting of the current Annual Meeting Chairperson, the immediate past Chairperson, the next Annual Meeting Chairperson, and the Executive Director will be formed. This committee will assist the current Chairperson to meet the expectations noted below and will provide a method to train future Chairpersons. The immediate past Chairperson is expected to share lessons-learned. This committee also will review and approve the early draft list of Annual Meeting Tracks.

Program Committee

The Program Committee shall determine/recommend the learning objectives, themes/concepts, content and speakers for the event to the Director, North America Operations.

The Program Chair is responsible for recruiting additional committee members. A limited number of representatives shall serve on this committee and may be recruited from the membership at large. The Program Chair should strive to have balanced representation from academia, contract organizations, vendors, etc. The committee composition shall strive to have no more than one representative per company/organization. The term for a program committee member may not be more than 3 consecutive years. An individual may serve on the committee after a 2-year hiatus.

Each approved Track will have a lead chairperson. Where possible, each Track will include a team consisting of persons from Europe, Japan and the US. Tracks such as Regulatory, Clinical, IT, Project Management, GCP, Medical Writing, Clinical Safety, and Statistics should have global teams. In addition, each track chairperson shall assure that a member of a related SIAC, if it exists, has input to the track content, unless the track chairperson is a member of said SIAC.

The members of the Coordinating Committee, the Track Chairpersons and the additional persons assigned constitute the Annual Meeting Program Committee.

Ad Hoc Committees

The Program Chairperson may create ad-hoc committees to address specific needs of the meeting. Members of these committees are not subject to the term limitation of the program committee.

Expectations: The Annual Meeting Chairperson and the Program Committee are expected to:

1. Involve interested members in meeting planning and presentations 2. Review evaluations from past Annual Meetings and determine in changes in procedures or policies are necessary based on this feedback 3. “Reward” active participants in past meetings and in other DIA programs with opportunities for additional responsibility, e.g., Session Chairperson, Track Chairperson 4. Attempt to provide a focus on more than a single country in at least 50% of the sessions 5. Provide at least 20% of the sessions on FDA-related issues 6. Encourage innovative (new ideas) sessions, which may be limited in interest but which could provide unique opportunities for discussion of issues that might not be discussed at other industry meetings 7. Utilize the Annual Meeting as a testing ground for future workshop topics 8. Minimize the redundancies between session topics 9. Minimize concurrent sessions on similar topics 10. Maximize the number of volunteers who participate in the meeting (minimize the number of roles/times an individual participates with exception as noted in #11) 11. Encourage cooperation and sharing of resources/ speakers between tracks, especially for supported and government speakers 12. Encourage attendance and active participation of representatives of regulatory agencies (being certain to follow the established procedures) 13. Solicit input from the membership and/or Core Committees of appropriate SIACs on topics of interest for sessions and presentations. And request assistance from SIAC Core Committees in obtaining speakers as needed. 14. Support DIA’s Continuing Education program by offering programs that are fair balanced and free of commercial bias. 15. Provide a report on the status of the Annual Meeting to the DIA Board of Directors at the December Board Meeting. The report should focus on: -content of the program; validity and timeliness -how the program represents the membership -action plan for ensuring quality of the program -type and number of volunteer opportunities/activities -marketing strategy/plans -innovations/new ideas/improvement to program 16. Inform Track and Session Chairpersons that sessions are not to be promotional in nature. 17. Ask Track Chairpersons and the Director, North American Operations to evaluate session and speaker quality. They shall encourage all Session Chairs to actively seek session evaluations 18. Provide feedback to Session Chairperson and Speakers.

Annual Meeting Program Process

The DIA Director, North American Operations will provide each member of the Program Committee and each Session Chairperson a copy of this Policy & Procedures,

instructions for Track and Session Chairpersons, instructions for obtaining speakers from worldwide regulatory agencies, budgetary restraints (including limitations on the number and level of fully funded speakers, and their participation in multiple sessions), due dates and draft and approved copies of the Annual Meeting Grid (day by day, session by session schedule). The Director will interact directly with the Annual Meeting Chairperson, the other Coordinating Committee members, Track Chairpersons, Session Chairpersons, and speakers as needed.

Track Chairpersons shall review each abstract submitted to their assigned track. Within 1 week of receipt of these abstracts, the chairpersons shall review the receipts to determine is the author submitted the abstract to the correct track. Incorrectly classified abstracts shall be brought to the attention of the DIA Director, North American Operations who, in turn, shall forward the abstract to the more appropriate track chairperson. Track chairpersons shall then rank each submitted abstract before the due date according to the following scale: A: accept; important topic; B: potential or backup, accept if space available; C: reject.

In addition to the submitted abstracts, track chairpersons may submit topics for inclusion in the program that were not included in abstracts but which, in the opinion of the Track Chairperson, are important and should be in the program. After approval of these additional session topics by the Director, NA Operations or a member of the Coordinating Committee, each Track Chairperson, or additional assigned person, will select Session Chairpersons who are recognized experts in the session topic.

Session Chairpersons: Session Chairpersons shall select speakers for their respective sessions who are recognized experts in the session topics and who can present the topic well. They must get approval from the Director, NA Operations for all proposed supported speakers before they make any arrangements with such speakers. Session Chairpersons must not contact potential speakers from FDA, EMEA or the EU Commission. These agencies have specified that all requests for speakers from their respective agencies be made via the DIA. Additionally, the DIA regional offices should be notified regarding requests for speakers from other agencies. Session Chairpersons should refrain from selecting more than three speakers per 1-½ hour session. They also must adhere to the instructions given to them by the Director of North American Operations (see below).

Session Chairpersons must receive approval from the Director, North American Operations for all proposed supported speakers before they make any arrangements with such speakers. The requests to the Director, North American Operations must be made at the latest by April 1 of the year of the Annual Meeting. Requests received after this date may not be honored because of budgetary requirements. No more than 25% of the speakers at the Annual Meeting will be supported.

Meetings of The Committee: The Program Committee shall meet as determined by the Director, North America

Operations. The meetings may be face-to-face opportunities or teleconferences. They will serve to continually update the development of the program and measure the progress toward the completion of the program in accordance with the agreed timelines. DIA will facilitate these meetings.

DIA Volunteer Code of Conduct As constituents of a nonprofit, multidisciplinary, neutral forum for sharing information that optimizes the process of drug development and lifecycle management, volunteers should reflect the diversity in the global membership and should take into account regional representation, professional interest area, and work place setting. The spirit of this document attempts to uphold DIA’s Core Values of: passion for mission and vision; integrity; accountability and trust; treating people with respect and dignity; diversity; neutrality; and social responsibility. Volunteers shall at all times abide by and conform to the following Code of Conduct in their capacity as a DIA volunteer: General Expectations

1. Volunteers shall make decisions in the best interests of the organization. 2. Volunteers shall contribute to a collegial, inclusive, professional, positive, and respectful work environment

for fellow volunteers, stakeholders, and staff, and shall model the best in volunteer behavior. 3. Volunteers shall know, understand, and support DIA’s mission, vision, core values, purpose and goals and

become familiar with and follow DIA policies, procedures, guidelines, and the Volunteer Code of Conduct while acting on behalf of DIA.

4. Volunteers shall not discriminate and shall be respectful of ethnic, national, and cultural differences. 5. Volunteers shall use DIA’s marks, insignia, name, logos, and trade dress (collectively, “DIA Marks”) in

compliance with guidelines issued by DIA from time to time. 6. Volunteers shall at all times obey all applicable laws and regulations of the relevant government

authorities, including all laws and provisions that govern appropriate conduct in the work place while acting on behalf of DIA.

Meetings and Communication

1. While acting on behalf of DIA, professional behavior and respectful discourse shall be required of volunteers. Disruptive or inappropriate behavior toward other volunteers, stakeholders or staff is unacceptable.

2. Only information deemed for public knowledge may be shared or discussed outside DIA, unless specifically authorized to do so by the Executive Director and/or the President. No volunteer shall share, copy, reproduce, transmit, divulge or otherwise disclose any confidential information related to the affairs of the Association, and each volunteer will uphold the strict confidentiality regarding any information discussed at meetings or any other deliberations and communications. Questions regarding the confidential nature of DIA information or documents shall be directed to the appropriate staff person or Board member.

3. Volunteers are not permitted to speak on behalf of DIA or the Board to external parties, such as the media or other interested parties unless specifically asked to do so by the Executive Director and/or the President.

4. All contractual agreements are the responsibility of the DIA office. Volunteers will not make such commitments on behalf of the DIA, except in accordance with established DIA policies.

5. All DIA correspondence, regardless of the medium, is a reflection on the Association. E-mail communications shall follow the same professional standards as verbal communication. E-mails may be considered legal documents and, therefore, caution shall be exercised when recording written opinions and statements pertaining to the role of the volunteer in DIA. The use of the “blind copy” function is strongly discouraged when conducting official DIA business.

6. Volunteers shall support DIA to other volunteers, members, and stakeholders. Inappropriate communication by email or in any public forum about DIA, its volunteers, staff, stakeholders, policies, procedures or guidelines is not acceptable. Issues regarding DIA shall be taken up in private with the appropriate DIA staff member.

7. Participation in committee meetings (in-person and teleconferences) is typically required to fulfill a volunteer’s duties.

Relationship with Other Volunteers, Stakeholders and Staff 1. Volunteers shall understand the scope of their authority and exercise good judgment in their dealings with

other volunteers, stakeholders, staff, suppliers and the general public and shall respond to all constituents and the needs of the Association’s members in a responsible, respectful and professional manner.

2. Volunteers shall not request special or personal favors or extensive information from other volunteers, stakeholders, or staff, without prior consultation and agreement of the Executive Director.

3. DIA events are professional gatherings and therefore appropriate behaviors are expected. Volunteers shall adhere to DIA policies, procedures, guidelines, and the Volunteer Code of Conduct in all interactions with other volunteers, stakeholders, staff, vendors, and other constituents.

Avoiding Conflict of Interest

1. No volunteer will use any information provided by the Association or acquired as a consequence of the volunteer’s service to the Association in any manner other than in furtherance of his or her volunteer duties. Furthermore, volunteers will not misuse Association property or resources and will at all times keep the Association’s property secure and not allow any person not authorized by DIA access to such property.

2. Volunteers shall not persuade or attempt to persuade any member, exhibitor, sponsor, supplier, contractor, or any other person or entity with an actual or potential relationship with the Association to terminate, curtail or not enter into its relationship to or with the Association, or in any way to reduce the monetary or other benefits to the Association of such relationship.

3. Volunteers are expected to act at all times in the best interest of the Association and not for personal or third-party gain or financial enrichment. When encountering potential conflict of interest, volunteers will identify the conflict and report it to the Director of Volunteer and Member Services / Chairperson of the Regional Advisory Committee who may ask them to remove themselves from all discussions and voting on the matter.

4. Volunteers will not accept gifts, gratuities, free trips, honoraria, personal property, or any other item of value from any person or entity as a direct or indirect inducement to provide special treatment to such donor with respect to matters pertaining to the Association without fully disclosing such items to the Director of Volunteer and Member Services in advance.

Confidential Communication Upon termination of service, volunteers will promptly return to the Association all documents, electronic and hard files, reference materials, and other property not already on file in the DIA office. Such return will not abrogate him or her from the continuing obligations of confidentiality with respect to the information acquired as a consequence of his or her tenure. Violations of the Code of Conduct

1. DIA staff shall resolve any issues with volunteers in a professional manner. 2. Volunteers violating the Code of Conduct may be asked to resign their volunteer position and may be

requested to discontinue future volunteer roles. The Executive Director will determine if this action is necessary and will notify the volunteer.

3. Volunteers who have been removed from a volunteer position have 30 days to appeal the decision to the Executive Committee of the Board which will review the situation and respond within 30 days of the request for appeal. All decisions of the Executive Committee are final.

Volunteer Code of Conduct Revision – Board Approved March 22, 2009

46th DIA Annual MeetingProgram Development Schedule

as of October 28, 2009Deadline Task item

October 29, 2009 Deadline for all abstracts to be ranked

November 2, 2009 (week of) Accepted abstract notification

November 16, 2009 (week of) Declined abstract notification

November 17, 2009 10:30am ET LIVE Session chair webinar with Program chair, Dr. Gaby Danan, click here for details

December 17, 2009 Names of speakers and presentation titles to DIA, including FDA participant requests (provide detail to DIA by this deadline and book your hotel room prior to the room block opening to the public)

January 13, 2010 Deadline for session details, speakers to make PRELIMINARY PROGRAM ANNOUNCEMENT

February 5, 2010 PRELIMINARY PROGRAM to print

March 1, 2010 Final requests for FDA participants to DIA

April (late) The official 46th DIA Annual Meeting PowerPoint Template is now available!· 2010 Annual Meeting PowerPoint Template· 2010 Annual Meeting PowerPoint Template-for US Government Employees

April (month of) Speaker webinars available for viewing

M 3 2010May 3, 2010 C l ti f ONSITE FINAL PROGRAM Completion of ONSITE FINAL PROGRAM

June 2, 2010

1st upload of presentation

Drawing #1 Speakers, submit your presentation* to the EPAC system by the June 2nd COB deadline and you’ll be placed in a random drawing to win (1) 8GB Apple iPod touch.

Drawing #2 Session chairs who have all of their speaker presentations* and session chair presentation* to the EPAC system by the June 2nd COB deadline will be placed in a random drawing to win (1) 8GB Apple iPod touch.

*To qualify:• Presentations must be on a designated 46th Annual Meeting PowerPoint Template.• Only one company logo should appear within the entire presentation.Please refer to the DIA Policy Concerning Promotion of Products and Services from the Podium at DIA-sponsored Programs

NOTE: Presentations submitted by June 2 may be updated afterwards. Please plan to have your completedpresentations to the EPAC system no later than June 7 COB as Session chairs will begin their review of your presentation.

June 7, 2010 FINAL upload of PowerPoint presentations to be submitted to EP@C system

June 8-11, 2010 Session chairs to review all submitted presentations and conduct follow up calls or emails to speakers who have not submitted their presentation for review.

June 13-17, 2010

46th DIA Annual MeetingWalter E. Washington Convention Center

801 Mount Vernon Place NW Washington, DC 20001

Guideline Summary For Track and Session Chairpersons

46th DIA Annual Meeting June 13-17, 2010 Washington, DC

Sessions will be scheduled as follows:

Monday, June 14 – Plenary session at 8:30am and concurrent sessions at 10:30am, 1:30pm and 3:30pm.

Tuesday, June 15 – Track Plenary session at 8:00-9:30am and concurrent sessions at 10:00am, 2:00pm and 4:00pm

Wednesday, June 16 – Sessions at 8:30am, 10:30am, 1:30pm and 3:30pm.

Thursday, June 17 – Sessions at 8:30am and 10:30am. Each concurrent session will last for 90 minutes. There will be 30-minute refreshment break between sessions and a 90-minute luncheon break Monday, Wednesday and Thursday. Tuesday’s luncheon will begin at 11:30 and end at 2:00pm.

Notification of the exact day and time of each session will be made in early January. Recording of Sessions / Speaker Disclosures All sessions will be recorded and made available to DIA members and meeting attendees. All session participants (session chairs, speakers and panelists) are required to complete an online consent form. All session participants must also disclose any significant financial interest or other relationship with the manufacturer(s) of any commercial product(s) and/or providers of commercial services discussed in an educational presentation, as well as any discussion of unlabeled or unapproved drugs or devices. An online recording consent form/speaker disclosure form must be completed by all session participants in order to participate in the program. In support of the ACCME guidelines, DIA has implemented a process where anyone in a position to control the content of an educational activity must disclose all relevant financial relationships with any commercial interest. Should a conflict of interest exist as a result of the financial relationship, this must be resolved prior to the activity. Individuals who do not complete the online AV consent and disclosure form may be ineligible to participate as a faculty member for this program. Session Participants:

Each session is limited to a total of 4 individuals, including the session chairperson. This allows each speaker 20-25 minutes for presentations and 15-30 minutes for questions and answers in the session. Written approval from the DIA office is required for any session which is requesting to include more than 4 individuals. Session chairs may also present.

The meeting registration fee is waived for up to 4 individuals per session, including the session chairperson (provided speakers are from different organizations). DIA will register confirmed participants. Tours, tutorials and the networking reception require separate registration and payment. Session participants are responsible for their own travel/hotel expenses (unless they qualify for support – see Speaker Support below).

DIA discourages the use of co-session chairs and co-presenters for presentations. All requests for co-presenters must be sent to the US DIA office for approval before presenters are invited. Approved co-chairs or co-presenters should not be from the same organization (see Speaker Affiliations below).

Speaker Support:

Each session is limited to no more than one supported participant per session. Supported speakers include full-time government/ regulatory employees. Full-time academic and not-for-profit employees will be considered if budget allows. All requests for support must be sent to the US DIA office for approval before session chairs/speakers are invited and before the Preliminary Program is developed.

Supported speakers will receive roundtrip coach/economy airfare (arranged through the DIA travel agent), plus 2 nights hotel room and tax, and per diem of up to $50 per day for no more than 3 days to cover food and miscellaneous expenses. Local transportation and airport parking costs will be covered outside of the per diem if the amount is significant. Receipts must be submitted at time of reimbursement.

It has been brought to DIA’s attention that unauthorized third party providers are contacting our speakers and exhibitors to book their hotel reservations. These providers may require reservations be fully prepaid, are non-refundable and may be subject to steep cancellation and change fees. Please note that Travel Planners is the exclusive housing provider of the 46th DIA Annual Meeting. Should you choose to book with any provider other than Travel Planners, DIA will not have the ability to assist you with any issues you may have with the terms of their agreement.

Speaker Affiliations

Please ensure that there is good representation/diversity in each session. If applicable, government, academia, CSO and industry perspectives should be represented.

More than 1 participant from the same company in any given session is not permitted unless discussed with DIA in advance. Should an exception be made, one complimentary registration for the meeting will be given to the company.

DIA meetings will be educational, not commercial and promotional. Speakers who represent a CSO or are independent consultants, etc. must be advised that their presentation is not to be of a commercial or promotional nature, and that logos and company information may only be included on the first page of the PowerPoint presentation and printed materials. In addition, speaker clothing may not carry logos or other company-specific emblems. All session participants must follow the “DIA Policy Concerning Promotion of Products and Services from the Podium” (attached).

When selecting speakers, please note that it is DIA’s goal to have 50% of the sessions globally oriented.

Government Speakers

Individuals from the following regulatory organizations may not be contacted directly to participate: FDA, EMEA, EU, MHRA, SFDA and Health Canada. Per regulatory agency policy, DIA is to officially request the participation of speakers from these organizations. The session chair is to provide DIA with the requested speaker’s name and topic to be presented as early as possible to ensure the best opportunity for receiving approval from the respective agency. Speakers from other organizations may be contacted directly by the session chair.

Continuing Education Guidelines for the Annual Meeting

All presentations are to be fair balanced and free of commercial bias.

All sessions must have at least two (2) learning objectives that clearly indicate what participants will be able to do after attending the session.

All program participants in a position to control content (this includes

program chairperson and committee members, track chairs, session chairs, speakers, and panelists) must provide DIA with any significant financial relationships they have with the manufacturer of products or services as discussed within their presentation or with regard to the content of the session/meeting (for those who are not speaking).*

If a program participant (as noted above) has a conflict of interest as a result of the financial relationship, this will need to be resolved prior to the meeting.

If a program participant does not provide disclosure to DIA, he/she will not

be permitted to participate in the meeting.

When discussing therapeutic options, it is DIA’s preference that only generic names and not trade names be used. If it is necessary to use trade names, please use the trade names of all products being discussed.

All recommendations involving clinical medicine in a CME session must be

based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.

* Please see attached Disclosure Question and Answer document.

Disclosure Questions and Answers DIA is accredited by the Accreditation Council for Continuing Medical Education (ACCME) and the International Association for Continuing Education and Training (IACET). Frequently asked questions regarding participant disclosure and responses are noted below. Why do volunteers need to disclose? As an accredited provider DIA is required to provide its activity participants with any conflict of interest a program participant may have.

Who needs to disclose? Anyone in a position to control content: Program chairperson(s) Track chairs Session chairs Speakers Panelists Authors DIA staff developing content (The above are referred to in this document as program participants)

What needs to be disclosed? All relevant financial relationships between the commercial supporter (if applicable) or manufacturer of services discussed within the activity and/or presentation. Program chairpersons and track chairs need to provide disclosure related to the development of the activity; session chairs, speakers, and authors need to provide disclosure related to the content of their presentation.

If a program participant has no financial relationships, that also needs to be disclosed.

Does a program participant need to disclose all financial relationships? No, only those that pertain to the content of the educational activity or presentation.

Does a program participant need to disclose the amount of the financial relationship? No.

If a volunteer participates as a program participant in multiple activities, does he/she have to complete a disclosure form for each activity? Yes. The disclosure is pertinent to the content/presentation of the given activity.

Do the new Accreditation Council for Continuing Education (ACCME) Standards affect all DIA activities? No. The policies and procedure established to support the new ACCME Standards only apply to CME activities (those activities offering category 1 credit).

How do the new Standards impact DIA’s CME program? All program participants must provide disclosure in order to participate in the educational activity. If a program participant has a conflict of interest, the conflict must be addressed prior to the educational activity. If resolution cannot be made, CME credit may or may not be offered for the activity.

DIA Policy Concerning Promotion of Products and Services From the Podium at DIA-Sponsored Programs

The Drug Information Association encourages and supports the exchange and dissemination of information pertaining to research and development of health care products, regulatory processes, emerging technologies, and information management. The Association does this by providing its members a neutral forum for education and discussion opportunities concerning the latest technologies and processes. Preservation of the neutrality of this forum, fostering collaborative efforts among academia, contract houses, contract research organizations, health regulatory authorities, industry, practitioners, and vendors, is essential to the success of DIA. The Association draws a clear distinction between the dissemination of information and outright commercial promotion of a consultant, commercial product, research institution, or service. At DIA-sponsored programs, presentations by persons affiliated with commercial organizations or educational institutions that provide services or products must be limited to scientific, technical or process issues. Presentations should not overtly endorse or recommend a specific product or service. The theme and content of slides, overheads, handouts and other presentation aids should not promote a commercial product or service. This also applies to the use of company logos, which may only appear on the first slide of a slide presentation. In addition, speaker clothing may not carry logos or other company specific emblems. In this way, DIA meetings will be educational, rather than commercial and promotional. The DIA Office will create and disseminate publicity pertinent to a DIA meeting, workshop, training course, tutorial, or any other DIA-sponsored activity. All such publicity will be distributed directly from the DIA Office. Individuals and organizations can, at their option, make tasteful announcements of their participation in DIA-sponsored meetings, but should refrain from doing so until confirmation of participation has been received from the DIA Office. Any advertising of participation in a DIA-sponsored meeting by an individual or an organization shall not use any copyrighted material from DIA or the DIA trademark. The DIA Board of Directors encourages the membership to provide feedback to the DIA Executive Director regarding violations of this policy. The Executive Director will address such violations directly with those involved. Remedies may include restriction on future participation at DIA events.

46h DIA Annual Meeting Program Participant Webinar

Attend one of the live webinars to learn best practices in leading or presenting at the DIA Annual Meeting! Webinar Date and Time Webex Address Session chair Webinar *for session chairs new to the DIA Annual Meeting Program

April 19, 2010 10:00am ET

https://diahome.webex.com/diahome/onstage/g.php?d=713126585&t=aPassword: washingtondc (all one word, no space)

Speaker Webinar *for speakers new to the DIA Annual Meeting Program

April 22, 2010 10:00am ET

https://diahome.webex.com/diahome/onstage/g.php?d=710130602&t=aPassword: washingtondc (all one word, no space)

Veteran Session chair and Speaker Webinar *for veteran participants of the DIA Annual Meeting Program

April 19, 2010 11:30-12:30pm ET

https://diahome.webex.com/diahome/onstage/g.php?d=713514430&t=aPassword: washingtondc (all one word, no space)

Step #1 It is imperative that you perform a system test at least 24 hours before the webinar. Webex, our provider, periodically makes changes to their platform, which may affect the webinar performance on your computer. Even if you have participated in a DIA webinar before, you must test your system in advance to assure that everything is functioning properly. Please go to the Test Site below to perform this system check. To receive the Webinar over the Internet, your computer must have: Browser Microsoft® Internet Explorer 5.2 or higher Netscape® Navigator 7 Computer 166Mhz Pentium-based PC with Microsoft® Windows® 98, NT, ME, XP or 2000 Sun JVM 1.4* for Microsoft JVM (all versions supported by Microsoft Windows OS shown above) Sun SPARCstation with Solaris 8 or 9 Audience: 64 MB RAM *If you need to install Java Virtual Machine (JVM) on your system, please download it from the Sun Microsystems website. Internet Connection Speed 56k or faster Display 800x600 pixel resolution or greater (1024x768 pixels recommended) Attendees using Macintosh OS Microsoft IE 5.2 Macintosh OS 10.2X To test your system compatibility, click on the link below. https://developers.webex.com/api/jointest/index.php Step #2 To join the event Please choose which webinar you would like to join and click on the web link above Password: washingtondc (all one word, no space) After you click on the link, here are some additional instructions: 1. Click the Join button 2. Enter your name and email address 3. Enter the password: washingtondc (all one word, no space) 4. Click to join the event

There is no dial in number. All sound will be broadcast through your computer’s speakers. Please make sure the volume is all the way up. DIA representatives will be making periodic announcements prior to the live event, but there is no hold music.

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Welcome to the Annual Meeting Program Development Website Go to the DIA Homepage, www.diahome.org and click on the 46th DIA Annual Meeting Icon

At the DIA’s 46th Annual Meeting pages, click on “Responsibilities” from the Speaker’s Corner tab.

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1. Log into the pages with your user id and password. 2. If you do not know your id, Click Here to be directed to the login reminder

page.

Please note that due to DIA’s database upgrade, passwords are now case sensitive.

You may be asked to update your user id if you have not logged into the website within the past year.

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If this is your first time accessing the Program Development Website for the 46th Annual Meeting, you will see the Profile Disclosure Terms & Conditions page noted below, please review and click “Next” button when complete

Profile Page Update contact information and Scroll down to bottom of page. Please make sure all fields with a red asterisk next to them are completed.

You will have an opportunity to provide a brief 300 character biography on this page or you will be able to edit a biography that we currently have on file.

Click Next

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Program Participant Disclosure Page Please review; complete all areas by scrolling to the bottom of the page and clicking the next button

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Program Participant AV (audio-visual release) Page Please review and complete all areas by scrolling to bottom of page and clicking the submit button.

My Responsibilities Page This page will show you all of your responsibilities up to date for the Annual Meeting Program. Click on Edit button to advance to the next page.

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Edit Session Page This page will detail all information already submitted to DIA. It is here where you may edit and update information. Please click the Next button to advance to the next page. Please note that if you step away from your computer while editing, you may risk losing edited information. Please be sure to hit the submit button (which can be found in at the end of the site to capture your information that you have updated)

Continuing Education Request Page This page displays current request for continuing education for your session. You will be able to edit this information before it is locked down and submitted for review to the DIA CE Committee. Click on Next button

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Edit Session Chair Detail Page Details as session chair will be displayed here, if edits are necessary click back to edit your profile or click next.

Edit Speakers Page Please review the 2010 Session Chair Resource Guide before inviting speakers to present in your session. The following page is where you can update with your speakers after they have been invited. Click next on the bottom of the page.

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Speaker Detail Page After you have submitted your speakers, you will be able to include presentation titles as you see appropriate. At a later stage, speakers will have access to this site to update their titles as needed.

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Session Confirmation Page This page displays all information that will be submitted to DIA. Scroll to bottom of page and click the SUBMIT button. Information will not be updated and saved unless you complete this last step. An email will be sent to verify that the information has been submitted successfully. Please allow 24-48 hours for the information to be reviewed by the DIA Annual Meeting Team. Once approved, your edits will be reflected on the website and seen when you access again.

Confirmation Page Click Okay to return to the My Responsibilities page:

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My Responsibilities Page

Contacts You have the option of sending an email to anyone associated with your session from the website. If you have more than one role for the meeting, select your criteria from the dropdown menu. At the Speaker’s Corner Tab, click on Contacts

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1. Go to Speakers Corner, Contacts, and an email template will appear. 2. Enter a Subject in the Subject line, type your message, highlight the

names to be included in your message and hit the send email button.