1987-2007 – edm’s 20th anniversary conference: 20th · pdf filening to facilitate...
TRANSCRIPT
20th Annual DIA Conference forELECTRONIC DOCUMENT MANAGEMENT
Topics to includel Important New Initiatives
“Convergence of Disciplines” l New and Exciting Session on
Records Management l Medical Writing for
eSubmissions l Standardized Process
Implementation l Labeling – SPL and PIMl Compliance and Validation
Issues and Challenges l Authoring and Life-cycle
Management Beyond theDocument Level
l Effective and AppropriateCommunication of SafetyInformation in an eCTD
l Enterprise KnowledgeManagement: Going Global and Beyond
l The Regulatory Perspective
Reconnecting the Processto the Delivery of
Safe and EffectiveMedical Products
DISCOVERYEARLY
DEVELOPMENTFULL
DEVELOPMENTPOST
MARKETING
1987 2007
ChangeMgmt
SafetyInfo
Systems
Labeling
Reg / ITGateway
eRecords
DDMAC
Medical Writing
Standards
Life Cycle Mgmt - start to finish
e-HealthcareIndustry
SDTM ECG
CRO In-Licensing
eCTDSPL/PIM
SAFE
Project Mgmt
ProcessReengineering
Training Programs
SOPs/Validation
EDS SDS LD CS Pre-Cin Phase I Phase II Phase III Labeling Safety
REGISTER ONLINE!www.diahome.org
THIS PROGRAM WAS DEVELOPED BY THE FOLLOWING SPECIAL INTEREST AREA COMMUNITIES DOCUMENT AND RECORDS MANAGEMENT, ELECTRONIC REGULATORY SUBMISSIONS,AND MEDICAL WRITING
FEBRUARY 6-9, 2007 Loews Philadelphia Hotel l Philadelphia, PA, USA
20TH ANNUAL DIA
1987-2007 – EDM’s 20th Anniversary Conference:
Who Should AttendThis meeting will benefit those who areengaged in EDM and looking for improvementand efficiency as well as those just beginningthe journey. Sessions will include introductorythrough advanced topics, technical and busi-ness, large pharma and small pharma, US andglobal focus, agency and industry perspectives.
Program OverviewOver the past 20 years, the DIA EDMConference has served as a platform for thediscussion of emerging standards andprocesses for the creation, submission, andretention of regulatory information. Withinthe past 2 to 3 years, there has been anincreasing recognition of a broader and morecomplex environment that critically needsinteroperability standards to create, electroni-cally exchange, and manage this ever-growingarray of medical and regulatory information.Being proactively positioned and strategicallyaligned will require internal thought and plan-ning to facilitate process reengineering andretooling.
While change is inevitable, the need for readilyavailable current information, while still ensur-ing data protection, is essential. Traditionalbusiness roles are being remodeled and re-scoped with the convergence of disciplinesand cultural change. It is essential in this com-plex environment to not only continuouslyreanalyze the business and informationprocess, but to analyze the impact to touchpoints, intersections, interdependencies, andinteroperability connectors all along the drugdevelopment continuum to ensure the deliveryof safe and effective medical products.
Program Co-chairsSTEPHEN E. WILSON, DRPH, CAPT. USPHSDirector, Division of Biometrics IIICDER, FDA
KAY BROSSSenior PKI Specialist, Information Security and Solutions
PROCTER & GAMBLE COMPANY
LAURA J. SHERMAN, MBAVice President Submissions and ValidationIMPACT SYSTEMS INC.
Program CommitteeMICHAEL BRENNAN, PHDVice President, Global Regulatory Operations CENTOCOR, INC.
NANCIE E. CELINIPresident, CAB, INC.
MARY L. COLLINSDirector, Regulatory Affairs, IMAGE SOLUTIONS, INC.
HELLE GAWRYLEWSKI, MADirector, Medical WritingJOHNSON & JOHNSON PHARMACEUTICALS R&D, LLC
LOIS HOUSEHOLDERSenior Manager, Regulatory Affairs OperationsTAP PHARMACEUTICAL PRODUCTS, INC.
KIM W. NITAHARA, MBAChief Executive Officer, META SOLUTIONS, INC.
VIRGINIA VENTURARegulatory Information Specialist, CDER, FDA
GARY G. WALKERAssociate Regulatory, Director, Global Data ManagementQUINTILES TRANSNATIONAL CORP.
Member Early-bird Rate — Register by January 16 and Save $180!
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Statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association.
Speakers and agenda are subject to change without notice.
Recording of information, in any type ofmedia, is prohibited at all DIA events
without prior written consent from DIA.
Meeting attendees are welcome to visit the exhibits during the workshop and receptions.
For meeting information, contact Joanne Wallace,Program Manager at the DIA office in Horsham, PA bytelephone +1-215-442-6180, fax +1-215-442-6199 oremail: [email protected].
For exhibit information, contact Erin Gilliland at +1-215-442-6149, fax +1-215-442-6199 or email:[email protected].
Register 3 individuals from the same company and receivecomplimentary registration for a 4th! All 4 individuals mustregister and prepay at the same time – no exceptions. DIAwill apply the value of the lowest applicable fee to this compli-mentary registration; it does NOT include fees for optionalevents or DIA membership. You may substitute group partici-pants of the same membership status at any time; however,administrative fees may be incurred. Group registration is notavailable online and does not apply to the already-discountedfees for government or charitable nonprofit/academia.
To take advantage of this offer, please make a copy of this registration form for EACH of the four registrantsfrom your company. Include the names of all four groupregistrants on each of the forms and return them togetherto DIA.
Meeting Contact and Exhibit Information
Group Discounts
TRAVEL AND HOTEL The most convenient airport is Phila-delphia International Airport and attendees should make airlinereservations as early as possible to ensure availability. The LoewsPhiladelphia Hotel is holding a block of rooms at the reducedrate below until January 14, 2007, for the DIA meeting atten-dees. Room availability at this rate is guaranteed only until thisdate or until the block is filled.
Single $179 Double $179
Please contact the Loews Philadelphia Hotel by telephone at+1-215-627-1200 and mention the DIA meeting. The hotel islocated at 1200 Market Street, Philadelphia, PA 19107, USA.
To obtain schedule information and the best fares, call UnitedAirlines’ Specialized Meeting Reservations Center at +1-800-521-4041. Make sure you refer to Meeting ID Number 571AK.Dedicated reservationists are on duty 7 days a week from 8:00 AM to 10:00 PM EST.
This special offer applies to travel on domestic segments of allUnited Airlines, United Express, PED, and United code shareflights (UA*, operated by US Airways, US Airways Express and Air Canada).
UNITED AIRLINES & US AIRWAYSSave through Area Pricing and Discount Fees
Participants with Disabilities DIA meeting facilities and overnightaccommodations are accessible to persons with disabilities. Services willbe made available to sensory-impaired persons attending the meeting ifrequested at least 15 days prior to meeting. Contact the DIA office toindicate your needs.
20TH ANNUAL DIA
Learning ObjectivesAt the conclusion of this meeting, participants should be able to:
l Recognize the many eCTD lifecycle management issues and challenges
l Identify organizational challenges associated with the interactionamong disciplines
l Identify challenges associated with change management
l Enumerate the developing standards and how they fit into the largereHealthcare industry
l Interpret regulatory compliance in the context of electronic documentmanagement
l Recognize challenges associated with interoperability
The Drug Information Association (DIA) has been reviewed and approved asan Authorized Provider by the International Association for ContinuingEducation and Training (IACET), 1620 I Street, NW, Suite 615, Washington,
DC 20006. The DIA has awarded up to 2 continuing education units (CEUs) to participantswho successfully complete this program and tutorial(s).
To receive a statement of credit, please visit www.diahome.org. Detailed instructionson how to complete your credit request and download your certificate will be pro-vided onsite.
Disclosure Policy: It is Drug Information Association policy that all faculty participating incontinuing education activities must disclose to the program audience (1) any real or appar-ent conflict(s) of interest related to the content of their presentation and (2) discussions ofunlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will be includedin the course materials.
Continuing Education Credit Allocation(*IACET CEUs are not available for the plenary sessions or the post-conference workshops)
Full-day Tutorial: .7 IACET CEUs Half-day Tutorials: .3 IACET CEUs
Conference: 1.3 IACET CEUs
Tuesday, February 6, 3 – 7pm Exhibitor Registration and Booth Set-up
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Wednesday, February 7, 9 – 10am
David B. Nash, MDChairman, Department of Health PolicyJefferson Medical College ofThomas Jefferson University
David Nash is the Dr. Raymond C. andDoris N. Grandon Professor and Chairmanof the Department of Health Policy at Jefferson Medical Collegeof Thomas Jefferson University in Philadelphia.
In 1990, Dr. Nash, a board certified internist, founded theoriginal Office of Health Policy at Jefferson Medical College.From 1996 to 2003, he served as the first Associate Dean forHealth Policy at Jefferson Medical College. In 2004, he wasnamed co-director of the Masters Program in Public Health at Jefferson and was named a finalist for the Annual DiscoverAward for Innovation in Public Health by Discover magazine.
In 1995, he was awarded the Latiolais (“Lay-shee-o-lay”) Prize by the Academy of Managed Care Pharmacy for his leadershipin disease management and pharmacoeconomics. He alsoreceived the Philadelphia Business Journal Healthcare HeroesAward in October 1997 and was named an honorary distin-guished fellow of the American College of Physician Executivesin 1998.
Traditionally named one of the top 100 most powerful personsin healthcare by Modern Healthcare, his national activitiesinclude appointment to the JCAHO Advisory Committee onPerformance Measurement, the CIGNA Physician AdvisoryCommittee, membership on the Board of Directors of theDisease Management Association of America (DMAA), andChair of an NQF Technical Advisory Panel – four key nationalgroups focusing on quality measurement and improvement. He continues to be recognized as one of the principal facultymembers for quality of care issues at the American College of Physician Executives in Tampa, FL, and the developer of the ACPE Capstone Course on Quality. Dr. Nash is on theNational Advisory Committee for the Robert Wood JohnsonFoundation Partnerships in Quality Education program. He isalso a member of the Board of Trustees of Catholic HealthcarePartners in Cincinnati, Ohio – one of the nation’s largest inte-grated delivery systems – and chairs the Board Committee onQuality and Safety.
Internationally recognized for his work in outcomes manage-ment, medical staff development, and quality-of-care improve-ment, he has published more than 100 articles in major medicaljournals. He has edited fifteen books, including A SystemsApproach to Disease Management, Connecting with the NewHealthcare Consumer, and The Quality Solution. He currentlyserves as editor-in-chief of four major national journals, includ-ing P&T, Disease Management, Biotechnology Healthcare, and the American Journal of Medical Quality.
Hang ten with old buddiesand new “dudes” at this exciting beach bash celebrat-ing the 20th Anniversary ofDIA’s EDM Conference.
Experience all the amenitiesof a tropical paradise in historic Philadelphia as the33rd floor of the Loews Hotel is transformed into abeautiful Hawaiian Island.
Special prizes will be awarded to attendees wearingHawaiian shirts. Come dressed to impress and enjoy somegood food and good fun—Hawaiian style.
Aloha!!
Ride the Wave!20th Annual EDM GalaThursday, February 8, 2007 � 6 – 8pm Loews Hotel in Philadelphia
Exhibitor Information Keynote Speaker
Exhibit Hall HoursWednesday, February 7 9:30am - 6:30pm
Light refreshments will be served from 5 - 6:30pm
Thursday, February 8 9:30am - 3pm
Don’t miss this exhibiting opportunity!For more information, contact Erin Gilliland
by telephone at +1-215-442-6149 or by email at [email protected].
Exhibit booths are still available.Reserve your space today!
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Submission Standards: Basic Strategyand Organizational Impact
Structured Content Authoring
Crossing the BRIDG to the Future:Implementation Case Studies of
the HL7/CDISC/BRIDG Model to Support Interoperability
Next Generation Tools for Structured Authoring
Tuesday, February 6, 20077 - 9am Tutorial Registration and Continental Breakfast
9am - 5pm Full-day Tutorial#1 Document Management Fundamentals and Beyond: Content Management Moves to the Next Era
8:30am - 12pm Concurrent Morning Tutorials#2 Writing the CTD – Learning from Best Practices #3 Practical Management of eCTD Life Cycle#4 Regulatory Compliance Requirements for Electronic Records, Documents and Submissions:
Predicate Rule and Part 11 System Design and Validation Considerations
12 - 1:30pm Tutorial Registration
1:30 - 5pm Concurrent Afternoon Tutorials#5 Guidance-compliant eCTDs#6 Introduction to Drugs, Biologics, and Medical Devices: Regulatory, Process, and Technology Needs
and Solutions for Information Management
3 - 7pm Exhibitor Registration and Set-up
4 - 6pm Attendee and Speaker Registration
Wednesday, February 7, 2007
7:30 - 8:30am Registration and Continental Breakfast
8:30 - 9am Welcome and Opening Remarks
9 - 10am Keynote Address – David B. Nash, MD, MBA, Thomas Jefferson University
10 - 10:30am Refreshment Break in the Exhibit Hall (Hall opens at 9:30am)
10:30am - 12pm Plenary Session: The eHealth Initiative and Ethics and Academia
12 - 1:30pm Luncheon in the Exhibit Hall
1:30 - 3pm Parallel Tracks
Conference at a Glance
5 - 6:30pm Reception in the Exhibit Hall
TRACK ARegulatory Compliance and Validation:
Current Topics, Issues, and Trends
Using Risk Analysis During Validation toEnsure Regulatory Compliance…
Practical Considerations in AssuringRegulatory Compliance of a Commercial
Off-the-shelf Product…
A New Paradigm for ValidatingDocument and Content Migrations
TRACK BeArchiving: The Forgotten Component
of Information Management
Speakers will discuss the need for and methods to achieve
comprehensive electronic management and archiving over the life cycle of those records
TRACK C
Influencing the Standards Landscape
Overview presentation andpanel discussion on the
ongoing standards development environment
TRACK AGlobal eLabeling – the Regulatory
Perspective on SPL and PIM, and theChallenges of SNOMED SPL Coding
SNOMED Coding in the SPL Standard
FDA Experience of SPL to Date
Status of PIM Implementation in theEuropean Procedures and Practical
Experience to Date
TRACK BTransitioning to eCTDs for
DDMAC Submissions
Current Submission Practices – Paper
Hybrids
eCTD (with XML Backbone)
Summary of F2F and Looking at the Future
TRACK C
3 - 3:30pm Refreshment Break in the Exhibit Hall
3:30 - 5pm Parallel Tracks
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Thursday, February 8, 20077:30 - 8:30am Registration and Continental Breakfast
8:30 - 10am Regulatory Update Session 1 – US Regulatory Update� FDA Special Presentation � Electronic Secure Gateway Initiative� FDA Standards Initiative
10 - 10:30am Refreshment Break in the Exhibit Hall
10:30am - 12pm Regulatory Update Session 2 – International Regulatory Update� Status of US/eCTD Implementation � Additional presentation being developed� Status of European eCTD Implementation and eSubs
12 - 1:30pm Luncheon in the Exhibit Hall
1:30 - 2:45pm Regulatory Update Session 3 – Electronic Submissions and eCTDs from a FDA Reviewer Standpoint� Case Study of an eCTD Application � NDAs in Electronic Format: A Clinical Reviewer’s Perspective� INDs in Electronic Format: A Pharm/Tox Reviewer’s Perspective
2:45 - 3:15pm Refreshment Break in the Exhibit Hall (Hall closes at 3:15pm)
3:15 - 4:15pm Regulatory Update Session 4 – Explanation/Clarification Regarding Withdrawal of FDA Guidances� Withdrawal of Electronic Submission Guidances: What It Means, What FDA Expects� How to Make the Transition to eCTD
4:15 - 5:30pm Regulatory Town Hall Q&AAsk the Regulators: To submit your questions in advance, see instructions on page 12
5:30 - 7:30pm 20th Anniversary Gala
Friday, February 9, 2007
7:30 - 8:30am Registration and Continental Breakfast
8:30 - 10am Parallel Tracks
12pm End of Track Sessions
12:30 - 3pm Postconference Luncheon Workshops
#1 Digital Signatures: What is a Digital Signature and Why Should We Use It?
#2 Medical Writing SIAC: Are We Producing Useful Summary Documents?
#3 HL7 Regulated Publishing Standard: An Examination of the HL7 Regulated Publishing Standard
10 - 10:30am Refreshment Break
10:30am - 12pm Parallel Tracks
Enterprise StandardsEnterprise Business Process Modeling Standards
Content Management, Interoperable Exchange and Collaboration
The Virtual Research Organization – Integrating Systems andProcesses to Improve Clinical Trial Execution
TRACK ASuccessful Transitions – A Focus on eCTD
Getting Started with INDs in eCTD Format
eCTD Updates and Changes
Challenges and Changes Associated with Simultaneous Global eCTD Submissions
TRACK B
Information Standards: Safety, HL7, RPS, Labeling
SNOMED Opportunities and Challenges
MedDRA as an International Standard in Regulatory Framework
HL7 Regulated Product Submission (RPS) Message: Project Status Update
TRACK ALife-cycle Management:
From Start to Finish within eCTD
CMC (M3) Experiences and Perspectives
Nonclinical (M4) Experiences and Perspectives
Clinical (M5) Experiences and Perspectives
TRACK B
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Tuesday, February 6 (Tutorials Only)
9am - 5pm Full-day Tutorial 1
8:30am - 12pm Concurrent Half-day Tutorial 2
on the CTD format, this tutorial will show how understanding theprocess of creating and submitting a CTD can facilitate regulatoryreview. Experienced CTD medical/regulatory writers and regulatorswill share obstacles and solutions, providing insight into best ways toorganize and present data and ensure a useful, accurate, and authori-tative summary.
Learning Objectives: At the conclusion of this tutorial, participantsshould be able to:• Recognize best practices in producing CTD clinical summary
documents• Identify constraints that the eCTD places on submission docu-
ments• Utilize solutions presented for the placement of integrated safety
and efficacy analyses
Target Audience: Writers with moderate experience in writing CTD sections who want new insights and advice.
#2 Writing the CTD – Learning from BestPracticesLevel: Intermediate (.3 IACET CEUs)InstructorSandra J. HeckerPresident, Hecker and Associates, LLC
ParticipantsFrank Hubbard, Medical Communications Scientist, AstraZeneca,Peggy Boe, RN, Director, Professional Services and Medical Writing,Image Solutions, Inc.; and Nancy R. Katz, PhD, President andPrincipal Medical Writing Consultant, Illyria Consulting Group, Inc.
The primary goal of the CTD clinical summaries in Module 2 is tofacilitate the review process by providing a concise, readable, andbalanced summary of the key data and conclusions drawn from theclinical trials and integrated across the development program. Usingcase studies from sponsors who have submitted applications based
7 - 9am Tutorial Registration and Continental Breakfast
#1 Document Management Fundamentalsand Beyond: Content Management Moves tothe Next Era Level: Beginner/Intermediate (.7 IACET CEUs)InstructorsNancie E. CeliniPresident, CAB, Inc.Melonie C. WarfelDirector Life Sciences, Adobe Systems IncorporatedJacquie BeckSenior Vice President, eLearning, Brookwood Media Arts
This signature tutorial continues to be an important foundationsession for conference participants. However, twenty years havebrought about significant changes in systems, processes and newchallenges for the industry. The document and records manage-ment burden that organizations face is more complex requiringnew tools and capabilities to manage content across the enterpriseand through the full information life cycle. Smaller start-up org-anizations may face technical and financial constraints whenacquiring systems and document management systems can beunder utilized as well as some common tools that users alreadyhave on their desktop. Lifecycle management can be difficult andcostly to implement.
This session will explore the stages that content evolves through,from draft to finalization. Examples of tools that can help toeffectively collaborate and manage content will be explored anddiscussed.
This session begins with the basic building blocks of electronicdocument management systems today including terminology, con-cepts, strategies for acquiring and implementing systems and mostimportantly, a review of the most common problems faced by thebiopharmaceutical industry that document management systems
can improve, enhance and enable. With input from the SpecialInterest Area Community on Document and Records Management(DRM), this tutorial is designed with 20 years of retrospective his-tory in mind and the next 20 years as the focal point. Movingbeyond the fundamentals this unique session will explore, in twoparts, the following key issues:
• Basic terminology, concepts• How to search for, evaluate, and implement electronic systems
(a primer)• Extending the “document centric” view to the “content centric”
view• Electronic collaboration: what it means – the components• Lifecycle management: processes and workflows• Managing the electronic review process• eLearning and the implications to the organization
Learning Objectives: At the conclusion of this tutorial, participantsshould be able to:
• Define key document management terms and concepts
• Identify the key issues/problems that content managementaddress today
• Define collaboration
• Distinguish the promotional stages (i.e. draft to review)
• Define lifecycle management and the importance of workflow
• Identify tools that can be used as “fast-win alternatives” to managecontent in a simple, low-cost manner
Target Audience: This tutorial is designed for EDM/RM projectteam members involved with the assessment, selection and imple-mentation of systems; end users of EDM/RM systems; and systemsdecision makers.
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8:30am - 12pm Concurrent Half-day Tutorials 3, 4
1:30 - 5pm Concurrent Half-day Tutorial 5
12 - 1:30pm Tutorial Registration
#4 Regulatory Compliance Requirements for Electronic Records, Documents andSubmissions: Predicate Rule and Part 11System Design and Validation ConsiderationsLevel: Beginner/Intermediate (.3 IACET CEUs)InstructorKim W. Nitahara, MBAChief Executive Officer, META Solutions, Inc.
This tutorial will provide an overview of the primary FDA regulationsand guidance regarding electronic records, documents, and submis-sions, including the computer systems that create and maintain them.The information will focus on the issues, problems, and concernsthat affect the computer systems design and validation of electronicrecord, document and submission management, and publishingprocesses and systems. The presentation will include a review of the21 CFR 11 “Electronic Signatures; Electronic Records” regulations,as well as the underlying “Predicate” regulations that govern GxP and regulatory submissions to the FDA. An update on the status ofexpected changes to the 21 CFR 11 regulations and guidance will beincluded. Practical information and approaches to meet the regulatorycompliance requirements will be presented and discussed with partic-ipants, using industry examples and actual FDA inspection results.
Learning Objectives: At the conclusion of this tutorial, participantsshould be able to:• Identify the relevant FDA regulations and guidance that impact
their electronic records, documents and submissions• Discuss and analyze the current regulatory compliance expectations,
including design and validation issues for electronic document andpublishing systems
• Interpret the regulations and guidance to formulate realistic andjustified plans and standards for their company’s electronic records,documents, submissions, and related computerized systems
Target Audience: This tutorial is designed for managers and person-nel in information technology and management, regulatory affairs,compliance, and submissions, as well as regulatory submission con-tent contributors and project managers.
#3 Practical Management of eCTD Life CycleLevel: Intermediate (.3 IACET CEUs)InstructorKenneth VanLuvaneePresident and CEO, Apyx, Inc.
The eCTD life cycle specification changes how we viewsubmissions. This tutorial will discuss the practical challenges of submitting and maintaining an eCTD submission, includ-ing strengths and weaknesses of the model. Specific issues to be discussed will include a discussion of the eCTD life-cycle model itself, challenges and opportunities posed by themodel, and options for specific solutions that can be applied to managing the inherently dynamic life cycle of an eCTD.
Learning Objectives: At the conclusion of this tutorial, partici-pants should be able to:
• Describe the eCTD life-cycle model starting from initial submission
• Explain what the life-cycle model can and cannot do
• Summarize the issues surrounding eCTD life-cycle manage-ment from a records management perspective
Target Audience: This tutorial is designed for regulatory publishers, publishing managers, and archive managers respon-sible for publishing and managing eCTD submissions and components.
This half-day tutorial will provide an overview of FDA’s eCTDGuidance and a practical discussion on developing a guidance-compliant format for an eCTD submission.
Learning Objectives: At the conclusion of this tutorial, participants should be able to:
• Explain the basic elements of eCTD guidance documents
• Discuss the content requirements for an eCTD
• Summarize how to develop an eCTD that facilitates review
Target Audience: This tutorial is designed for regulatory affairspersonnel, submission content contributors and project managers.
#5 Guidance-compliant eCTDsLevel: Beginner (.3 IACET CEUs)InstructorsGary GensingerDirector, Regulatory Review Staff CDER, FDABronwyn CollierAssociate Director, Regulatory Affairs, Office of Drug Evaluation III,CDER, FDAVirginia VenturaRegulatory Information Specialist, Office of Business Support, CDER,FDAArmando Oliva, MDAssociate Director, Policy, Office of New Drugs, CDER, FDA Norman Schmuff, PhDDeputy Director, Division of New Drug Chemistry III, CDER, FDA
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10 - 10:30am Refreshment Break in the Exhibit Hall (Hall opens at 9:30am)
7:30 - 8:30am Registration and Continental Breakfast
8:30 - 9:00amPlenary Session — Welcome and Opening Remarks
Session Chair
Keynote Speaker
Brief Retrospective Reflection of 20 YearsWilliam Brassington, Acting Executive Director, Drug Information Association
Stephen E. Wilson, DrPH, CAPT. USPHS, Director, Division of Biometrics III,CDER, FDA
9 - 10am Plenary Session — Keynote Address
Nancie E. Celini, President, CAB, Inc.
Wednesday, February 7
3 - 7pm Exhibit Registration and Set-up
4 - 6pm Attendee and Speaker Registration
1:30 - 5pm Concurrent Half-day Tutorial 6
#6 Introduction to Drugs, Biologics, andMedical Devices: Regulatory, Process, andTechnology Needs and Solutions forInformation ManagementLevel: Beginner (.3 IACET CEUs)InstructorKim W. Nitahara, MBAChief Executive Officer, META Solutions, Inc.
This tutorial will provide an overview of the FDA-regulated research,development, manufacturing, and marketing of pharmaceuticals,biologics, and medical devices, including the products and servicesprovided by vendors and contractors. The presented regulatory top-ics will cover the FDA’s history, purpose, and authority, with anoverview of key FDA regulations and guidance that affect informa-tion producers, consumers, and managers. The regulated processeswill be described for both the industry and the Agency, includingdefinitions of organizational roles, responsibilities, process work-flows, and typical information management needs and solutions.
This tutorial will provide a general overview and background for allof the subjects that will be covered in the subsequent days of the con-ference, including a useful list of expected acronyms and definitions.
Learning Objectives: At the conclusion of this tutorial, participantsshould be able to:
• Explain how and why the FDA regulates pharmaceutical, biologic,and device research, development, manufacturing, and marketing
• Identify the differences and similarities between pharmaceutical,biologic, and device manufacturers’ workflow processes, organiza-tional roles, and information management needs
• Identify the relevance and applicability of topics presented duringthe sessions and presentations in this conference
Target Audience: This tutorial is designed for industry, govern-ment, academia, or vendor personnel who are either new to theindustry, or are unfamiliar with the other regulated, related indus-tries, and their regulatory requirements, processes, and informationmanagement needs.
High Quality Medical Care Costs Less: The Role of StandardizationDavid B. Nash, MDChairman, Department of Health PolicyJefferson Medical College of Thomas Jefferson University
Dr. Nash will review the current national need to measure and improve the quality andsafety of medical care. The theme of his talk is that by applying the science of processimprovement, including the use of standards and evidence based guidelines – we canlower medical costs and improve quality. This counter intuitive theme will highlightsuch issues as public accountability, use of practice guidelines, the role of the consumerand future prospects. It promises to be provocative and a challenge to the current modelof health care.
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1:30 - 3pm TRACK A
Parallel Tracks, Wednesday, February 7
Submission Standards: Basic Strategy andOrganizational ImpactSession ChairHelle Gawrylewski, MADirector, Medical Writing, Johnson & Johnson PharmaceuticalsR&D, LLC
This session will discuss the current and future organizationalimpact of XML authoring and changing from document levelto component level authoring. How will having access to struc-tured information change the way we approach the submissionprocess? A major advancement is the HL7/CDISC BRIDGmodel that will serve as the foundation of data interchange stan-dards and technology solutions. This session will also explore
specific implementation case studies where the BRIDG model isbeing used to support next-generation clinical protocol authoringtools to pre-populate downstream systems and documents.
Structured Content AuthoringAlison Buno, Senior Director, WRO, US Reginal Leader Pfizer Inc
Crossing the BRIDG to the Future: Implementation Case Studies of the HL7/CDISC/BRIDG Model to Support InteroperabilityCara Willoughby, Healthcare Data Standards, Digital Infuzion,Inc.
Next Generation Tools for Structured AuthoringJeremy Gratt, President, Modular Informatics, LLC
10:30am - 12pm Plenary Session
12- 1:30pm Luncheon in the Exhibit Hall
Session Chair
10:30 - 11:15am
11:15am - 12pm
Nancie E. Celini, President, CAB, Inc.
The eHealth Initiative: How does it impact the healthcare industry as well as indiv-iduals? What does it mean for clinical R&D, use/storage/access to information, and what impact does it have on standard e-documentation research?
Michael Fitzmaurice Senior Senior Advisor for, Information Technology, Office of theDirector, Agency for Healthcare Research and Quality, Ethics and Academia: Are we preparing tomorrow’s professional and how are thesestandards transforming that preparation?
Joel Dobbs, PharmD, Vice President, Information Technology, EISAI Medical Research
1:30 - 3pm TRACK B
Regulatory Compliance and Validation: Current Topics,Issues, and TrendsSession ChairKim W. Nitahara, MBAChief Executive Officer, META Solutions, Inc.
This session on “Regulatory Compliance” will focus on thecurrent industry thoughts and trends regarding regulatory com-pliance of electronic document management and electronicsubmissions systems and processes. These presentations willinclude several examples of identifying and assessing regulatoryand business requirements, and then preparing and implement-ing regulatory-compliant solutions to meet both the regulatoryand the business needs. The examples will include overviews ofthe regulatory and industry compliance expectations, anddetailed discussions concerning the practical compliance issuesthat were encountered in recent projects. Key topics willinclude computer system validation, risk analysis, security, 21CFR Part 11, and GxP compliance of electronic document andsubmission management systems and processes. Regulatory
compliance during the typical activities or phases in a projectwill also be covered, including requirements definition, selec-tion, acquisition, customization, installation, testing, user train-ing, and the migration of document content.
Using Risk Analysis During Validation to EnsureRegulatory Compliance of a Document ManagementSystem and ProcessCharles Lankford, CEO, PharmaSys, Inc.
Practical Considerations in Assuring RegulatoryCompliance of a Commercial Off-the-Shelf Product forDocument Management and Electronic SubmissionKalyan Gopalakrishnan, Executive Vice President, StrategicPlanning, TAKE Solutions Inc.
A New Paradigm for Validating Document and ContentMigrationsDavid Katzoff, Chief Architect and Managing Director, Content Solutions, Valiance Partners, Inc.
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3:30 - 5pm TRACK A
Influencing the Standards LandscapeSession ChairWilliam A. RosenExecutive Director, Pfizer Inc
At the DIA EDM meeting in 2006, PhRMA ERS identifiedkey areas of interest in the ongoing standards developmentenvironment. At that time, speakers issued a call to DIA meet-ing attendees to become more engaged in the standards domainthrough the large number of existing relevant organizations.
Objectives • An update on the relevant standards organizations and
key efforts within them, why you might care about theseefforts, the impact they might have on you, your efforts, or the organization you represent
• An overview of the Healthcare Information Technology(HIT) landscape describing key initiatives
• An effort to focus attention on the HIT domain and how the standards landscape is evolving within it
• A discussion of the impact that pharmaceutical industrycan and should have in standards development
This session will: • Address implications with regard to standards and HIT from
US and EU perspectives as well as key drivers for industryand health authorities
• Engage DIA EDM attendees in a discussion on the conse-quences of the biopharmaceutical industry not playing amore active role in this environment.
The session will consist of an overview presentation followedby a panel discussion. Anticipated participants in the paneldiscussion will include PhRMA, EFPIA, EMEA, FDA, andrepresentatives from relevant SDOs.
Panel participants:William A. Rosen, Executive Director, Pfizer IncEdward S. Tripp, Program Director, eSubmissions, AbbottLaboratoriesAndrew P. Marr, Director, eRegulatory Development, GlobalRegulatory Operations, GlaxoSmithKline, UKLise Stevens-Hawkins, Data Standards Coordinator, Center for Biologics Evaluation and Research, FDA
Parallel Tracks, Wednesday, February 7, continued
3 - 3:30pm Refreshment Break in the Exhibit Hall
1:30 - 3pm TRACK C
eArchiving: The Forgotten Component of InformationManagementSession ChairMichael Brennan, PhDVice President, Global Regulatory Operations, Centocor, Inc.
The Regulatory Archive function has long been a necessaryalthough unglorified function within pharma companies’ reg-ulatory affairs departments. The fact that the term “regulatoryarchive” is a misnomer confuses the issue. Most often, peoplethink of archive as dead storage of very inactive records.However, the regulatory archive contains very current infor-mation – recent and ongoing submissions; communications to and from health authorities while a product is under review by the agency, including letters, faxes, and emails; records ofteleconferences and face-to-face meetings – from first contactbetween sponsor and agency through to approval of an appli-cation, as well as the post-approval maintenance of the appli-cation required by regulations. Supplements to add newindications build on the original approved application, and the life cycle continues for quite some time. In the electronicera, archivists face a dilemma of how to archive records that
are no longer contained on paper. Electronic media such as CDsare not acceptable as an archival quality standard, and with theadvent of the FDA Gateway, we now transmit eCTDs to theagency without any tangible medium. This session will bringtogether industry representatives who have examined this issue and will address aspects of archiving electronic records over thelife cycle of those records. An FDA speaker has been invited, whowill bring to the discussion the agency viewpoint on these issues.
Claudia C. Powers, Executive Director, Information andKnowledge Integration, PRI Informatics, Bristol-Myers SquibbCompany
Susan Landis, Director, Global Regulatory Archives, WorldwideRegulatory Affairs, Centocor R&D, Inc.
Dennis DiFebbo, Manager, Global Regulatory Operations,GlaxoSmithKline
Thomas R. Provencher, Senior Director, Global Line Lead,Information & Records Management, Worldwide RegulatoryOperations, Pfizer Inc
If you have specific questions that you would like to ask the panelists regarding William Rosen’s session on Influencing the Standards Landscape, please send them to: Joanne.Wallace@ diahome.org (subject: “Questions for the Influencing the Standards of Landscape Session”). Questions will be compiled and finalized by the Session Chairs and panel participants.
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US Regulatory UpdateSession ChairStephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics III, CDER, FDA
This first Update Session by key FDA representatives presentsan up-to-date progress report, with a focus on current FDAstrategies, guidance, regulations, submission projects and stan-dards, and compliance initiatives. The topics to be addressedinclude development of common systems and standards, elec-tronic review tools, regulatory submission guidance development.
FDA Special PresentationMalcolm Bertoni, Office of the Commissioner, FDA
FDA Standards InitiativeRandy Levin, MD, Associate Director for Medical Informatics,CDER, FDA
Electronic Secure Gateway InitiativeMark Gray, Office of the Commissioner, FDA
8:30 - 10am Regulatory Update Session 1
Global eLabeling – the Regulatory Perspective on SPLand PIM, and the Challenges of SNOMED SPL CodingSession ChairTerry HardinSenior IT Architect, IBM Life Sciences
Late in 2005 Structured Product Labeling became the requiredformat for electronic content of labeling submissions in theUS. Concurrently, Product Information Management (PIM)became optional in the EU for labeling submitted as part of a centralized procedure review. Both labeling initiatives arebased on the use of XML standards, but have differentapproaches and business drivers, and because there are twodifferent standards, pose tremendous challenges to industry.
3:30 - 5pm TRACK C
Transitioning to eCTDs for DDMAC SubmissionsSession ChairRob Labriola Director, Regulatory Operations, Sepracor Inc
This session will focus on the successes and challenges shiftingfrom traditional paper submissions to electronic submissions.This will also include discussion and testimony from sponsorsutilizing eCTD format and the new FDA Electronic Submis-sions Gateway for DDMAC submissions. The extent andimpact on an organization’s internal business process regardingelectronic review and approval to eSubmission and beyondwill be explored. Case studies and results from a PhRMAindustry survey will be presented.
The session will conclude with a panel Q&A of presenters:
Current Submission Practices – Paper Lee-ann Montano, Manager, Regulatory Affairs Novo Nordisk,Inc.
Hybrids Victoria Dormer, Product Maintenance and Compliance,Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals Inc.
eCTD (with XML Backbone) Doug Kent, Senior Regulatory Associate, Centocor, Inc.
Summary of F2F and Looking at the Future Rob Labriola, Director, Regulatory Operations, Sepracor Inc.
5 - 6:30pm Networking Reception in the Exhibit Hall
The FDA has the HL7 XML Structured Product Labeling standardfor labeling submissions, and included in this is the SNOMED terminology. This session will examine how the SNOMED coding terminology is part of SPL, and discuss the FDA and EMEA experiences to date with these XML labeling initiatives.
SNOMED Coding in the SPL StandardDoris McGinness, Terminology Manager, SNOMED
FDA Experience of SPL to Date Gary Gensinger, Director, Regulatory Review Support Staff,CDER, FDA
Status of PIM Implementation in the European Proceduresand Practical Experience to DateTimothy Buxton, Head of Sector, Project Management, EMEA
7:30 - 8:30am Registration and Continental Breakfast
Thursday, February 8
3:30 - 5pm TRACK B
10 - 10:30am Refreshment Break in the Exhibit Hall
If you have specific questions that you would like to ask the panelists regarding Rob Labriola’s Transitioning to eCTDs for DDMAC Submissions, please send them to: Joanne.Wallace @diahome.org (subject “Questions for the Transitioning to eCTDs for DDMAC Submissions Session.” Questions will be compiled and finalized by the Session Chairs and panel participants.
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4:15 - 5:30pm Regulatory Town Hall Q&A
If you have specific questions that you would like to ask thepanelists regarding electronic submission standards, processes,
regulations, guidances, or initiatives, please send them to:[email protected]
(subject: “Questions for the Regulators”)
Questions will be compiled and finalized by the EDM ProgramCommittee and the DIA Document and Records Management(DRM) and Electronic Regulatory Submissions (ERS) SIACCore Teams. DIA will provide the final list of questions to the pan-elists prior to the session for their consideration.
Please note that not all questions may be answered due to time limitations.
Session ChairsKim W. Nitahara, MBA, Chief Executive Officer, META Solutions, Inc.Stephen E. Wilson, DrPH, CAPT. USPHS, Director, Division of Biometrics III, CDER, FDA
Ask the Regulators! This Town Hall session is one of the morepopular features of our annual electronic document managementmeeting. A panel of regulatory agency representatives will be avail-able to answer questions and share dialogue with industry. This is aunique opportunity to learn about the latest FDA and Europeaninitiatives and to obtain current and practical advice from keyregulatory agency personnel that are responsible for electronicsubmission processing, standards, and reviews.
Thursday, February 8, continued
3:15 - 4:15pm Regulatory Update Session 4
Withdrawal of Electronic Submission Guidances: What ItMeans, What FDA ExpectsArmando Oliva, MD, Associate Director, Policy, Office of NewDrugs, CDER, FDA
How to Make the Transition to eCTDGary Gensinger, MBA, Director, Review Technology Staff, Office of Business Process Support, CDER, FDA
Session ChairVirginia Ventura, Regulatory Information Specialist, Office ofBusiness Support, CDER, FDA
This session will provide an explanation and clarification of the re-cent withdrawal of guidances governing traditional NDA, ANDAand annual report electronic submissions to the FDA. Informationprovided will include background, timelines, what will and won’t beaccepted electronically, and how to make the transition to eCTD.Practical and technical considerations will be discussed.
2:45 - 3:15pm Refreshment Break in the Exhibit Hall (Exhibit Hall closes at 3:15pm)
Case Study of an eCTD Application Virginia Ventura, Regulatory Information Specialist, Office ofBusiness Process Support, CDER, FDA
INDs in Electronic Format: A Pharm/Tox Reviewer’s PerspectiveLeslie McKinney, PhD, Reviewer, Division of Reproductive andUrologic Drug Products, CDER, FDA
NDAs in Electronic Format: A Clinical Reviewer’s PerspectiveLesley-Anne Furlong, MD, Medical Officer, Division of Reproductiveand Urologic Drug Products, CDER, FDA
Session ChairGary Gensinger, MBA, Director, Review Technology Staff, Office of Business Process Support, CDER, FDA
This session delves into the perspective of electronic submissionsand eCTDs from an FDA reviewer standpoint. Perspectives dis-cussed will include how the review process is approached and howelectronic submissions affect that process; how information isshared electronically; and the different challenges faced in complet-ing IND and NDA reviews. A case-study of one eCTD applicationwill be showcased, along with practical advice on how to avoidcommon mishaps.
1:30 - 2:45pm Regulatory Update Session 3
12 - 1:30pm Luncheon in the Exhibit Hall
Status of US/eCTD ImplementationGary Gensinger, MBA, Director, Review Technology Staff, Office of Business Process Support, CDER, FDA
Status of European eCTD Implementation and eSubsTimothy Buxton Head of Sector, Project Management, EMEA, UK
Status of MEB eCTD Implementation and eSubsRob de Haan, Adjunct Director/Deputy Director CBG-MEBNetherlands
International Regulatory UpdateSession ChairMary L. Collins, Director, Regulatory Affairs, Image Solutions, Inc.
This session provides an overview and status of agency acceptance,review and approval of electronic submissions. Representatives fromFDA and European agencies will discuss accepted electronic for-mats, agency readiness, progress to-date, and future expectations ofelectronic submissions.
10:30am - 12pm Regulatory Update Session 2
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8:30 - 10am TRACK B
Successful Transitions – A Focus on eCTD Session ChairLois HouseholderSenior Manager, Regulatory Affairs Operations, TAP Pharmaceutical Products, Inc.
The transition to eCTD can present a variety of challenges. Thissession will provide insight into the challenges and changes asso-ciated with successful transitions to eCTD. The challenges mayrange from submitting an acceptable IND in eCTD format tosubmitting simultaneous global eCTD submissions. Thesespeakers will present the challenges they encountered, changesthat were made, or should be made, and lessons learned duringtheir transitions to eCTD.
Getting Started with INDs in eCTD Format John Aitken, Senior Director, Regulatory Operations, ElanPharmaceuticals
eCTD Updates and ChangesJoseph A. Cipollina, Director, New Technologies, GlobalRegulatory Science - Informatics, Bristol-Myers Squibb Company
Challenges and Changes Associated with SimultaneousGlobal eCTD SubmissionsArthur D. Edwards, Senior Director, Regulatory AffairsOperations, Alexion Pharmaceuticals, Inc.
Friday, February 97:30 - 8:30am Registration and Continental Breakfast
10:00 - 10:30am Refreshment Break
Parallel Tracks
10:30am - 12pm Parallel Tracks Continued
8:30 - 10am TRACK A
Enterprise StandardsSession ChairSheila MartinGlobal Regulatory Affairs and Safety Operations,Amgen Inc.
The session will introduce attendees to a wide range of relevantenterprise standards ranging from business process modelingstandards to various Enterprise Content Management standards.The session will also highlight how applying technology andprocess standards to the clinical trial business process andimprove clinical trial execution.
Enterprise Business Process Modeling StandardsTroy Denhardt, MBA, Senior Manager, Global RegulatoryAffairs and Safety Operations, Amgen Inc.
Navigating through the Global Maze of Standards,Consortia, Alliances, Requirements, and Best PracticesDavid M. Luce, President CommonPractice.orgThe Virtual Research Organization – Integrating Systemsand Processes to Improve Clinical Trial Execution Paul Fenton, Clinical IT Consultant, President, eClinica, Inc.
10:30am - 12pm TRACK A
SNOMED Opportunities and ChallengesRobert Wallace, Senior Manager, Global Regulatory and Safety Operations, Amgen Inc.
MedDRA as an International Standard in RegulatoryFrameworkPatricia Mozzicato, Medical Officer USA, Northrop GrummanCorporation
HL7 Regulated Product Submission (RPS) Message: Project Status UpdateJason Rock, Chief Information Officer, GlobalSubmit, Inc.
Information Standards: Safety, HL7, RPS, LabelingSession ChairGary G. WalkerAssociate Regulatory Director, Global Data Management, Quintiles Transnational Corp.
There are many information standards that impact ElectronicDocument Management and Submissions that have been devel-oped or are nearing development. A few of these standards suchas the HL7 RPS and MedDRA will be explored in this session.
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12:30 - 3pm Postconference Luncheon Workshop #1 — Digital Signatures
Parallel Tracks, Friday, February 9, continued
What is a Digital Signature and Why Should We Use It?Session ChairKay BrossSenior PKI Specialist, Information Security and Solutions, Procter & Gamble Company
Clarifying a digital signature vs an electronic signature is onlythe start. We will hear the current status of the SAFE initiativefor the digital signature industry standard including productcertification and vendor partner updates. We will hear two casestudies of SAFE signature implementation using two deliverysolutions. Special announcements will be included regardingthe first SAFE certification of product and of new SAFE-com-pliant tool suites. Concluding will be a Q&A panel includingthe SAFE CEO, industry implementation representatives, as
Preregistration is requested for Postconference Workshops. Please check the box on the registration form on page 16, if you plan to attend.
Preregistration is requested for Postconference Workshops. Please check the box on the registration form on page 16, if you plan to attend.
12:30 - 3pm Postconference Luncheon Workshop #2 — Medical Writing SIAC
Are We Producing Useful Summary Documents?Session Co-ChairsHelle Gawrylewski, MA Director, Medical Writing, Johnson &Johnson PharmaceuticalsBarbara Kamm, Medical Writing Project Manager, Allergan, Inc.,
The session will focus on the practice of producing summarydocuments, how to start, what to focus on, and how to keep theend in mind. Health authority reviewers and sponsors’ internal
reviewers are not finding the documents that are produced usefulfor the intended purpose. How do we get there? Come and hear what best practices are being used and share your ownexperience. We will also have MW SIAC members sharing themost important and valuable information that was summarized at the meeting.
A panel of Medical Writing Core Committee members andsome invited reviewers from FDA will be available for Q&A in this interactive forum.
10:30am - 12pm TRACK BCMC (M3) Experiences and PerspectivesDeanna Murden, Associate Research Fellow, Pfizer Global R&D
Nonclinical (M4) Experiences and PerspectivesBeth Fehrle, MBA, Associate Director, Worldwide RegulatoryOperations, Pfizer Global R&D
Clinical (M5) Experiences and PerspectivesLeah Kleylein, Senior Manager, Global eSubmission Standardsand Processes, Worldwide Regulatory Affairs, Centocor, Inc.Quality Aspects from an FDA PerspectiveNorman Schmuff, PhD, Deputy Diretor, Division of New DrugChemistry III, CDER, FDA
Life-cycle Management: From Start to Finish within eCTDSession ChairJoseph A. CipollinaDirector, New Technologies, Global Regulatory Science - Informatics,Bristol-Myers Squibb Company
The implications of life cycle need to be considered BEFOREpreparing your eCTD submissions. Industry experts will sharetheir experiences in preparing eCTD submissions with perspec-tives on the Quality (CMC), Safety (Nonclinical), and Efficacy(Clinical) modules.
12pm End of Track Sessions
12:30pm Postconference Luncheon Workshops
well as representatives from Adobe, Arcot and Microsoft. Comeprepared to ask your questions!
SAFE Digital IdentityMollie Shields-Uehling, CEO and President, SAFE BioPharmaAssociation
Implementing SAFE Digital Signatures using Adobe v7Kay Bross, Senior PKI Specialist, Information Security andSolutions, Procter & Gamble Company
Second Case StudyEileen Poland, Regulatory Affairs; Rich Ware, Legal, AstraZenecaCompanyPanel additions: Edward Chase, Standards Engineer, Adobe Systems, Inc.Scott Kern, Solutions Architect, Arcot CompanyLes Jorgan, Industry Technology Strategist, Microsoft Company
If you have specific questions that you would like to ask the panelists regarding Digital Signatures, please send them to:[email protected] (subject: “Questions for the Digital Signature Postconference Workshop”).Questions will be compiled and finalized by the Session Chair and the DIA ERS SIAC Core Team.
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Preregistration is requested for Postconference Workshops. Please check the box on the registration form on page 16, if you plan to attend.
12:30 - 3pm Postconference Luncheon Workshop #3 — HL7 Regulated Publishing Standard
An Examination of the HL7 Regulated ProductStandardSession ChairTerry HardinSenior IT Architect, IBM Life Sciences
The HL7 Regulated Product Submission (RPS) message goal is to establish a global electronic submission standard generalenough to handle all worldwide submissions. Functions requiredfor the standard include:
• Document Lifecycle• Reuse of documents across submissions• Product/submission management• Submission lifecycle• Computer aided review• Visibility into the product/submission• Allowing for regional differences
This workshop will examine the RPS message, the keys to success, design decisions, controlled vocabulary for the standard,testing to date, issues for the “next version,” as well as look at some open source input tools that are being used to build testsubmissions and valuable information that was summarized at the meeting.
Jason Rock, Chief Information Officer, GlobalSubmit, Inc.
Steven Speicher, Senior Software Engineer, IBM EmergingSoftware Standards
Terry Hardin, Senior IT Architect, IBM Life Science
DEVELOPMENT OF A CLINICAL STUDY REPORT
COURSE DESCRIPTION
Examine best practices for preparing integrated clini-cal study reports for pharmaceutical products.Discussion will focus on the structure and format ofa clinical study report, with special attention givento the inclusion and presentation of study-specificinformation and data.
WHO SHOULD ATTEND
� Clinical research and development professionals
� Medical writers
� Regulatory affairs personnel
� Biostatisticians
� Clinical operations professionals
COURSE INSTRUCTOR
Patricia Matone, PhDScientific Information Services, LLC
Learn the latest strategies for preparing clear, well-organized, and ICH-compliant clinical study reports.
COURSE HIGHLIGHTS� STRUCTURE AND FORMAT OF AN INTEGRATED CLINICAL STUDY
REPORT IN ACCORDANCE WITH ICH GUIDELINES
� INVESTIGATIONAL PLAN THROUGH STATISTICAL METHODOLOGY
� STUDY POPULATION AND PROTOCOL DEVIATIONS
� PLACEMENT AND PRESENTATION OF STUDY INFORMATION AND DATAIN VARIOUS REPORT SECTIONS, INCLUDING TABLES, APPENDICES, ANDSUPPORTING DOCUMENTATION
� SAFETY AND EFFICACY RESULTS
� PHARMACOKINETIC AND/OR PHARMACODYNAMIC ENDPOINTS
� ACCEPTABILITY OF ABBREVIATED STUDY REPORTS
LEARNING OBJECTIVESAt the conclusion of this course, participants should be able to:
• Recognize key regulatory requirements for integrated and abbrevi-ated clinical study reports
• Describe the structure and format of a clinical study report and itsrelationship to the clinical study protocol
• Explain the format and structure of a clinical study report
• Discuss various approaches to solving problems related to prepara-tion, protocols, patient disposition, compliance, and changes tostatistical methods
• Develop a comprehensive and easily reviewable clinical study report
Attend this DIA Training Course, February 6, 2007, at the Loews Philadelphia Hotel prior to the EDM Conference
ADDITIONAL
OPPORTUNITY!
Limited to 50 registrants – Register Early!www.diahome.org Co
-loca
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CONTACT & EXHIBIT INFORMATION: Conference: Contact Joanne Wallace at theDIA office by telephone +1-215-442-6180, fax +1-215-442-6199 or email [email protected]. Exhibit: Contact Erin Gilliland, Exhibits Associate, at the DIA office by tele-phone +1-215-442-6149, fax +1-215-442-6199 or email [email protected]. Fortabletop exhibit space, please check the box below.
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Registration Fees: If DIA cannot verify your membership upon receipt of registrationform, you will be charged the nonmember fee. Registration fee includes refreshment breaks,luncheons, and reception (if applicable), and will be accepted by mail, fax, or online.
MEMBER EARLY-BIRD OPPORTUNITY On or before AfterAvailable on nondiscount member fee only JAN. 16, 2007 JAN. 16, 2007
Member Fee US $1220 � US $1400 �
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member fee! www.diahome.org US $ 130 �
To qualify for the early-bird discount, registration form and accompanying payment must bereceived by the date above. Does not apply to government/academia/nonprofit members.
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Discount Fees MEMBER NONMEMBER*Government (Full-time) US $ 325 � US $ 455 �Charitable Nonprofit/Academia (Full-time) US $ 700 � US $ 830 �
*If paying a nonmember fee, please check one box above, indicating whether you want membership.
TUTORIALS Tuesday, February 6, 2007
Full-day Tutorial#1 9am-5pm Document Management Fundamentals and Beyond … US $ 650 �Half-day Tutorials Morning#2 8:30am-12pm Writing the CTD – Learning from Best Practices US $ 375 �#3 8:30am-12pm Practical Management of eCTD Life Cycle US $ 375 �#4 8:30am-12pm Regulatory Compliance Requirements for
Electronic Records, Documents, and Submissions … US $ 375 �Half-day Tutorials Afternoon#5 1:30-5pm Guidance-compliant eCTDs US $ 375 �#6 1:30-5pm Introduction to Drugs, Biologics, and Medical Devices … US $ 375 �
I will attend a Postconference Luncheon Workshop, Friday, February 9, 2007
#1 Digital Signatures US $ 50 �#2 Medical Writing SIAC US $ 50 �#3 HL7 Regulated Publishing Standard US $ 50 �
CANCELLATION POLICY: On or before JANUARY 31, 2007Administrative fee that will be withheld from refund amount: Member or Nonmember = $200 Tutorial = $50Government or Academia or Nonprofit (Member or Nonmember) = $100
Cancellations must be in writing and be received by the cancellation date above.Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their ownhotel and airline reservations. You may transfer your registration to a colleague atany time but membership is not transferable. Please notify DIA of any such substitu-tions as soon as possible. Substitute registrants will be responsible for nonmemberfee, if applicable. DIA reserves the right to alter the venue, if necessary. If anevent is cancelled, DIA is not responsible for any airfare, hotel or other costsincurred by registrants.
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20th Annual DIA Conference forELECTRONIC DOCUMENT MANAGEMENT
Reconnecting the Process to the Delivery of Safe and Effective Medical Products
Loews Philadelphia Hotel, Philadelphia, PA, USA
FEBRUARY 6-9, 2007 | Meeting ID #07003
1987-2007 – EDM’s 20th Anniversary Conference:
Member Early-bird Rate
Register by January 16
SAVE $180!