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The 8th Annual

Electronic Submissions Conference

eCTD: The Adventure Continues

Tutorials: November 17, 2009
Conference: November 18-19, 2009
PROGRAM CHAIRPERSONS

KENNETH R. V AN LUVANEE
Vice President, Global Professional Servicesr, Image
Solutions, Inc.

The Westin San Diego Hotel, San Diego, CA, USA

Discuss Current Developments in eCTD in the US and Europe,

Filing CTD-formatted Submissions in Other Markets, and Emerging
Technologies Affecting Electronic Submissions

GARY M. GENSINGER, MBA

Deputy Director, Office of Business Process Support

PROGRAM COMMITTEE

JOEL FINKLE

eCTD-formatted submissions have taken hold in the US and are on their way to doing the same
in Europe. Now eCTD is poised to become the preferred format for regulatory submissions in
many other regions, from South-central Asia to the Pacific Rim to Latin America. Australia and
Switzerland have both issued statements of intent to accept eCTD, while many other regions are
basing both paper and electronic submission formats on the CTD structure.

Director, Regulatory Informatics, Image Solutions, Inc.

TERRY D. HARDIN
Partner, PerfiTech Consulting

MATTHEW J. NEAL
Director, Global Regulatory Affairs and Safety
Amgen Inc.

LAURA J. SHERMAN, MBA

Managing Partner
Distributed Compliance Solutions LLC

CONCURRENT TUTORIALS
Tuesday, November 17 8:30

AM-12:00 PM

PM

#1 EU Regulatory Review Procedures and Their

Implications for eSubmissions Publishing

#4 US-EU eCTDs (Creating eCTDs for the US

and EU): Differences and Similarities

#2 INDs in eCTD Format

#5 eCTD Lifecycle Management

#3 eCTD Basics

#6 Metadata and Standards: How Metadata

Is Used from Protocol Definition to
Regulatory Submission

NANCY SMERKANICH
Vice President, Global Regulatory Affairs
Octagon Research Solutions, Inc.

Tuesday, November 17 1:30-5:00

WHO SHOULD ATTEND

This program will benefit individuals involved in:

VIRGINIA R. VENTURA

Regulatory affairs/operations

Project management

Team Leader, Electronic Submission Support

Office of Business Process Support
CDER, FDA

Document and data management

Information technology

Technical and medical writing

Data analysis/management

GARY G. WALKER
Associate Director, Enterprise Data Standards
Enterprise Data Council, Program Management Office
Quintiles Transnational Corp.

GEOFFREY WILLIAMS, P H D
e-Regulatory Liasion, Roche Products Ltd., UK

PROGRAM ADVISOR

LEARNING OBJECTIVES
At the conclusion of this conference, participants should be able to:


Discuss emerging and future trends in electronic submissions including Regulated Product Submission (RPS)

Identify challenges and benefits of transitioning to eCTD

Identify the various methods of submitting electronic submissions to global health authorities

Create guidance-compliant INDs, NDAs, MAAs, NDSs, DMFs, and ANDAs in eCTD format to ensure
acceptance and reviewability

Differentiate between guidance and regulation and their impact on the process

Recognize the vital role of good document management and best business practices in the overall process
of preparing the eCTD

Describe the role of eCTD standards and their impact to the development/delivery process

MARY L. COLLINS
Director, Regulatory and Industry Relations
Image Solutions, Inc.

CONTACT INFORMATION

Conference: Carrie Dunn

Phone +1.215.442.6181
email [email protected]
Exhibits: Shannon Lewis
Phone +1.215.442.6149
email [email protected]

THIS PROGRAM WAS DEVELOPED BY THE DIA DOCUMENT AND RECORDS MANAGEMENT,
E CLINICAL, ELECTRONIC REGULATORY SUBMISSIONS, MEDICAL WRITING, AND
REGULATORY AFFAIRS SPECIAL INTEREST AREA COMMUNITIES.

VISIT WWW.DIAHOME.ORG FOR A COMPLETE

SCHEDULE OF EVENTS!
%
DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1.215.442.6100 fax: +1.215.442.6199 email: [email protected]


BASEL, SWITZERLAND

TOKYO, JAPAN

MUMBAI, INDIA

BEIJING, CHINA

CONTINUING EDUCATION
The Drug Information Association (DIA) has been approved as an Authorized Provider by the International Association for Continuing Education and Training
(IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102. DIA is authorized by IACET to offer 1.6 CEUs for this program and tutorial(s).

Continuing Education Credit Allocation

Tutorials: .3 IACET CEU for each tutorial (maximum of .6 IACET CEU)

Conference: 1.0 IACET CEU

To receive a statement of credit, please visit www.diahome.org. Detailed instructions on how to complete your credit request and download your
certificate will be provided onsite.
Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the program audience (1) any real or
apparent conflict(s) of interest related to the content of their presentation and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will
be included in the course materials.
Learning Objectives are listed on the cover.

TUESDAY NOVEMBER 17

7:30

AM-6:00 PM

REGISTRATION

Concurrent Morning Tutorials

8:30 AM-12:00 PM

TUTORIAL #1: EU REGULATORY REVIEW PROCEDURES

THEIR IMPLICATIONS FOR eSUBMISSIONS PUBLISHING

group. The instructors will then identify how the different review procedures
impact the submission formats and requirements that can be used. The main
focus will be on the MAA dossier but will also briefly discuss associated submissions (CTAs, Scientific Advice, PIPs, etc.).

AND

TUTORIAL INSTRUCTORS

Geoffrey Williams, PhD

eRegulatory Liaison, Roche Products Ltd., UK

Learning Objectives:
At the conclusion of this tutorial, participants should be able to:

Hans Van Bruggen, MSc

Senior Regulatory Affairs Consultant, eCTDconsultancy B.V., Netherlands

Describe in high level the four different EU review procedures, being able
to identify:
Under what circumstances a particular procedure can be used
The distinguishing characteristics of each procedure
Identify the individual agency requirements that will need to be followed,
depending on the submission procedure chosen
Identify the dossier format options available based on the submission
procedure chosen
Identify the key sources of information about the procedures and the
dossier formats

The EU is a particularly complex environment to work in when it comes to creating regulatory submissions. EU legislation allows for Marketing Authorization
Application (MAA) dossiers to be submitted through one of four review procedures, depending on the type of product and the applicants own regulatory
strategy. Having determined the route of submission, the applicant may then
have to consider the individual country requirements from the 27 Member
States and the EMEA. Lastly, the applicant may also have options available as to
the presentation format for the submission itself (paper, NeeS, eCTD, etc.).
The tutorial will give an overview of the regulatory procedures and requirements at the level of detail needed within the Regulatory Operations/Publishing

TUTORIAL #2: INDS

IN

IMPD to IND as well as filing Canadian INDs to the agenda. Demonstrations

of a pilot eCTD IND will be provided.

eCTD FORMAT

TUTORIAL INSTRUCTORS

Nancy Smerkanich

Learning Objectives:
At the conclusion of this tutorial, participants should be able to:

Vice President, Global Regulatory Affairs, Octagon Research

Solutions, Inc.

Implement Practical Planning, recognizing the following:

Effect on authors of IND sections, specifically around document
granularity
Importance of tracking documents across functional areas
Document mapping from 21 CFR 312 to CTD Modules
Life cycle management
Prepare for eCTD: Identify process change and improvement needs
Collect and organize metadata
Utilize the Study Tagging File valid values
Recognize IMPD to IND document reuse
Discuss Canadian INDs in eCTD format

Matthew J. Neal
Director, Global Regulatory Affairs and Safety, Amgen Inc.
This half-day tutorial will focus on the practicalities and processes of creating
and maintaining INDs in the eCTD format. The use of the guidance and specifications needed for various types of submissions will be presented along with
common pitfalls and issues. Practical examples of how to track continuous
applications will be discussed; an activity on gathering metadata and case studies will all be part of this interactive tutorial. A focus on proper use of Study
Tagging Files will also be covered. This year we will add document reuse from

8:30 AM-12:00 PM

Concurrent Morning Tutorials continued

Learning Objectives:
At the conclusion of this tutorial, participants should be able to:

TUTORIAL #3: eCTD BASICS

TUTORIAL INSTRUCTORS

Recognize eCTD components and structures

Gain knowledge of eCTD vocabulary and available resources
Introduce the basic facets of preparing and assembling eCTDs
Recognize the basic regional differences between eCTDs for the US,
EU, and Canada
Introduce Study Tagging Files and Node Extensions for eCTDs, where
theyre used, and how theyre created
Identify areas for eCTD submission QC prior to final submission to the
health authority
Introduce basic eCTD life cycle management concepts

Terri M. Booth-Genthe, MS
Senior Director, Global Regulatory Affairs, Wyeth Pharmaceuticals

Kenneth R. VanLuvanee
Vice President, Global Professional Services, Image Solutions, Inc.
This practical publishing tutorial is intended for publishers who will be creating
their first or first few eCTD submissions. It will focus on important aspects of
creating eCTD submissions, how eCTD is similar to other forms of electronic
submissions, and how eCTD is different from other forms of electronic submissions or from paper submissions. Specific areas to be addressed will be document preparation along with author education, eCTD project management
concerns, considerations for Study Tagging Files, attribute naming and Node
Extensions and final QC considerations. There will also be a short, basic discussion of eCTD life cycle management suitable as a preparation for understanding application maintenance in eCTD format.

Please note that lunch is not served on tutorial day.

1:30-5:00 PM

Concurrent Afternoon Tutorials

TUTORIAL #4: US-EU eCTDS (CREATING eCTDS

US AND EU): DIFFERENCES AND SIMILARITIES

tutorial will address compliance with both the US and EU Module 1 specifications, as well as each regions unique requirements for Modules 2-5.

FOR THE

TUTORIAL INSTRUCTORS

Learning Objectives:
At the conclusion of this tutorial, participants should be able to:

Matthew J. Neal
Director, Global Regulatory Affairs and Safety, Amgen Inc.

Define the common contents within an eCTD

Describe the regional specific requirements for both the US and EU
eCTD specifications
Identify where additional ICH and regional eCTD specifications/
information can be found for further reference

Geoffrey Williams, PhD

eRegulatory Liaison, Roche Products Ltd., UK
This half-day tutorial will address in detail the practicalities of creating eCTDs to
be submitted in the US and the EU. The instructors will address the common
areas of the eCTD, as well as the US and EU regional differences in detail. The

Learning Objectives:
At the conclusion of this tutorial, participants should be able to:

TUTORIAL #5: eCTD LIFE CYCLE MANAGEMENT

TUTORIAL INSTRUCTORS

Laura J. Sherman, MBA

Describe the eCTD life cycle model starting from initial submission

Managing Partner, Distributed Compliance Solutions LLC

Explain the functionality of the life cycle model

Kenneth R. VanLuvanee

Summarize the issues surrounding eCTD life cycle management from

a records management perspective

Vice President, Global Professional Services, Image Solutions, Inc

The eCTD life cycle specification changes how we view submissions. This tutorial will discuss the practical challenges of submitting and maintaining an eCTD
submission, including 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 the model, and options for specific solutions
that can be applied to managing the inherently dynamic life cycle of an eCTD.

Afternoon Tutorials continued on page 4

Concurrent Afternoon Tutorials continued

1:30-5:00 PM

Learning Objectives:
At the conclusion of this tutorial, participants should be able to:

TUTORIAL #6: METADATA AND STANDARDS HOW

METADATA IS USED FROM PROTOCOL DEFINITION TO
REGULATORY SUBMISSION

Define metadata and how it may provide a consistent approach for data
definition from protocol definition to regulatory submission
Determine how metadata can improve data integration and aggregation
from multiple diverse sources such as CDMS, CRO, and legacy data
sources
Summarize, from a high-level perspective, how a metadata repository
might be utilized in an organization
Identify how a metadata governance model might be employed

TUTORIAL INSTRUCTORS

Gary G. Walker
Associate Regulatory Director, Global Data Management
Quintiles Transnational Corp.

Terry D. Hardin
President and CEO, PerfiTech Consulting
This tutorial will examine metadata and the multitude of standards where it is
used today from ADaM and BRIDG to SDTM. It will also examine how a metadata repository, and the proper governance models, may improve the speed of
initial development and regulatory submission through consistent use of metadata from end-to-end of the drug development process.

WEDNESDAY NOVEMBER 18
7:30-8:30

AM

REGISTRATION AND CONTINENTAL BREAKFAST

8:30-8:45

AM

WELCOME AND OPENING REMARKS

PROGRAM CHAIRPERSONS: Kenneth R. VanLuvanee, President and CEO, Apyx Inc.

Gary M. Gensinger, Director, Regulatory Review Support Staff, CDER, FDA

Plenary Session 1

8:45-10:00 AM

FDA UPDATE

A TALE

SESSION CHAIR:

Virginia R. Ventura

Gary M. Gensinger
Director, Regulatory Review Support Staff, CDER, FDA
In this opening session, speakers from FDA will present
up-to-date information on FDAs standards, expectations,
and experiences with eCTDs. Speakers will talk on FDAs
expectations for provision of electronic data, review of
clinical sections of eCTDs, and provide a case study review of
FDAs experiences with eCTD reviews.
10:00-10:30

AM

OF

TWO eCTDS: ENSURING REVIEWABILITY

Team Leader, Electronic Submission Support, Office of Business Process Support,

CDER, FDA

A CLINICAL REVIEWERS PERSPECTIVE

OF

ELECTRONIC SUBMISSIONS

Sarah Connelly, MD

Medical Officer, FDA

FDA DATA STANDARDS: AN UPDATE

Lilliam Rosario, PhD

Associate Director for Nonclinical Data Standards, Office of the Commissioner, FDA

REFRESHMENT BREAK

10:30 AM-12:00 PM Plenary Session 2

STATUS

OF eSUBMISSIONS IN US, EU, AND CANADA

SESSION CHAIR: Gary M. Gensinger
Director, Regulatory Review Support Staff, CDER, FDA
In this session, speakers from FDA, the European Union,
and Health Canada will discuss status, progress, and plans
for eCTDs and eSubmissions in their respective regions.
For those planning to submit electronically to any of these
regions, this is a cant miss session to hear directly from
the regulators.

FDA eCTDS
Gary M. Gensinger

Director, Regulatory Review Support Staff, CDER, FDA

EUROPEAN ESUBMISSIONS UPDATE

Rob de Haan, PhD

Adjunct Directeur/Deputy Director, CBG-MEB, Netherlands

SUBMISSIONS

AND

eCTD

IN

CANADA

Vianney Caron

Project Lead, eReview, Therapeutic Products Directorate, Health Canada

12:00-1:30

PM

LUNCHEON
4

TRACK 2 (ADVANCED)

TRACK 1 (ESSENTIAL)
1:30-3:00

PM

SESSION 1

EFFICIENT CREATION

OF

1:30-3:00

eCTD CONTENT

SESSION 1

PERSPECTIVES ON CDISC: STANDARDS

METADATA IN SUBMISSIONS

SESSION CHAIRPERSON

Michelle Herrera Foster, PhD

FOR

DATA

AND

SESSION CHAIRPERSON

Principal, Senior Regulatory Affairs Consultant

CTD Quality Consulting

Gary G. Walker
Associate Director, Enterprise Data Standards
Enterprise Data Council, Program Management Office
Quintiles Transnational Corp.

This session will discuss processes and considerations for more efficient
planning, authoring, and review of submission-ready documents for eCTD
from early investigational phase throughout marketing and postmarketing for global submissions. This will provide an overview of use of eCTD
templates, mapping to source documentation, granularity decisions, content reuse, life cycle management, and document management.

EFFICIENT PREPARATION OF eCTD DOCUMENTS

MANUFACTURING, AND CONTROLS

PM

FOR

This session will provide some perspectives on CDISC projects and standards initiatives relating to eSubmissions. There will be a report on an
ongoing CDISC/FDA pilot demonstrating the use of standards for an ISS,
a report on the progress of the CDISC SDTM Metadata Submission
Guidelines and an FDA perspective on the presentation and review of
clinical data.

CHEMISTRY,

Michelle Herrera Foster, PhD

Principal, Senior Regulatory Affairs Consultant, CTD Quality

Consulting

THE CDISC/FDA INTEGRATED SAFETY DATA PILOT: A CASE STUDY IN

IMPLEMENTING CDISC STANDARDS TO SUPPORT AN INTEGRATED REVIEW
Chris Decker, MS

GETTING IT RIGHT FROM THE BEGINNING: STRATEGIES FOR EFFECTIVE

CREATION AND MANAGEMENT OF NONCLINICAL CONTENT IN
THE eCTD

Life Sciences Director, d-Wise Technologies, Inc.

THE CDISC SDTM METADATA SUBMISSION GUIDELINES (SDTM-MSG):

AN UPDATE

Peggy Zorn, MS, MBA

Principal Consultant, Regulatory and Clinical Services,

Thomson Reuters

TOPIC-BASED AUTHORING: A NEW PARADIGM

CLINICAL CONTENT OF THE eCTD

FOR

Gary G. Walker

CREATING

Associate Director, Enterprise Data Standards, Enterprise Data Council,

Program Management Office, Quintiles Transnational Corp.

THE

FDA PERSPECTIVE

Nancy R. Katz, PhD

President and Principal Medical Writing Consultant, Illyria Consulting

Group, Inc.

3:00-3:30

PM

PRESENTATION

AND

REVIEW

OF

CLINICAL DATA

REFRESHMENT BREAK

TRACK 2 (ADVANCED)

TRACK 1 (ESSENTIAL)
3:30-5:00

ON

FDA Speaker Invited

PM

SESSION 2

3:30-5:00

CHANGING YOUR BUSINESS MODEL

OF YOUR eCTD

TO

GET

THE

PM

METADATA

SESSION 2

AND FUTURE
SESSION CHAIRPERSON

MOST OUT

TRENDS

SESSION CHAIRPERSON

Terry D. Hardin

Terri M. Booth-Genthe, MS

Partner, PerfiTech Consulting

Senior Director, Global Regulatory Affairs

Wyeth Pharmaceuticals

This session will examine metadata and how it is becoming increasingly

important for regulatory content from labeling to RPS. The speakers
will review the nature and use of metadata in document management,
outline the DIA EDM metadata reference model, discuss metadata from
the eCTD and RPS perspectives, and how metadata can improve the
eCTD submission assembly process.

Organizations have the choice whether or not the effort required to

produce an eCTD amount to more than merely a cost center.
The eCTD can provide major benefits beyond its role as an electronic
submission format and transport mechanism. The information it contains, how it's built, and how the content can be viewed and accessed,
can bring substantial efficiencies to the internal organization. Truly
extracting all the benefits out of implementing eCTD requires an indepth business understanding and associated paradigm shifts on the
part of your organization.
Track 1, Session 2 continued on page 6

Track 2, Session 2 continued on page 6

Track 1, Session 2 continued from page 5

Track 2, Session 2 continued from page 5

This session will cover:

METADATA

Many of the untapped benefits of eCTD

A first-hand description of the differences in staff skill set and knowledge requirements needed to build and maintain a successful submissions management model for your company
An overview of considerations when your company explores the
options of leveraging in-house staff or an outsource partner for eCTD
production

Keith Thomas

AND

SUBMISSION PROCESS COORDINATION

Product Strategist, Infrastructures For Information Inc.

AN INTRODUCTION

TO

RPS WHAT IT IS

PUBLISHING STAFF

IN AN

WHERE IT IS GOING

e-Regulatory Liaison, Roche Products Ltd., UK

THE METADATA DRIVEN SUBMISSION: RPS

DEVELOPING

AND

Geoffrey Williams, PhD

AND THE

FUTURE

OF

eCTD

Joel Finkle

eCTD ENVIRONMENT

Director, Regulatory Informatics, Image Solutions, Inc.

Terri M. Booth-Genthe, MS

Senior Director, Global Regulatory Affairs, Wyeth Pharmaceuticals

THE ROLE

OF THE

TECHNOLOGIST

IN

REGULATORY OPERATIONS

John Rice

Project Leader, Regulatory Innovation, Covidien

PRODUCING AND DELIVERING eCTDS: CONSIDERATIONS

IN-HOUSE STAFF, OUTSOURCE PARTNER OR BOTH

WHEN

DECIDING

Daniel F. Orfe, MS

Vice President, Global Regulatory Submission Services, Datafarm, Inc.

5:00-6:00

PM

NETWORKING RECEPTION

THURSDAY NOVEMBER 19

TRACK 2 (ADVANCED)

TRACK 1 (ESSENTIAL)
8:30-10:00

AM

SESSION 3

8:30-10:00

AM

SESSION 3

SUBMISSION PROJECT MANAGEMENT

ADVANCED LIFE CYCLE MANAGEMENT

SESSION CHAIRPERSON

SESSION CHAIRPERSON

Kenneth R. VanLuvanee

Nancy Smerkanich

Vice President, Global Professional Services

Image Solutions, Inc.

Vice President, Global Regulatory Affairs, Octagon Research Solutions, Inc.

The electronic Common Technical Document is celebrating its 6th birthday
this year! The metrics around its use are on the rise in all regions. The ongoing challenge for most companies continues to be in the area of life
cycle management at both the document and the dossier level. Perhaps the
biggest challenge is managing across regions.

This session will focus on one of the most practical, but also most frequently overlooked aspects of eCTD publishing project management. By definition, submissions are cross-departmental projects. This
session will identify approaches to effective submission project management, as well as hurdles and resolutions commonly seen when
managing submissions to successful completion.

eCTD GPS NAVIGATING

ELECTRONIC SUBMISSIONS

AROUND THE

POTHOLES

Many of these challenges are the result of lack of guidance. In lieu of guidance however, there are best practices that have arisen and been shared by
industry and vendors alike. This session will share some of these best practices, as they relate to day-to-day submissions. Case scenarios and samples
will be utilized.

OF

Katie Russo

Regulatory Affairs, Project Manager, Octagon Research

Solutions, Inc.

CMC/MOD 3 LIFECYCLE MANAGEMENT: LESSONS

REGULATORY BOOK OF KNOWLEDGE
Deanna Murden

EFFECTIVE PROJECT MANAGEMENT TECHNIQUES FOR THE

CREATION OF MARKETING APPLICATIONS IN eCTD FORMAT

ePharmaCMC, LLC

Rachel L. Cooper

ISSUES

Project Manager, Cato Research

eCTD PROJECT MANAGEMENT: MANAGING

FROM THE

AND INITIATIVES IN THE INDUSTRY

Joseph A. Cipollina
AGAINST

Senior Director, Regulatory Information and Submission Standards

Worldwide Regulatory Affairs and Quality Assurance, Pfizer Inc

TIMELINES

Emily Onkka

Associate Director, Regulatory Operations and Submissions,

Cadence Pharmaceuticals Inc.

ECTD

LIFECYCLE MANAGEMENT: ISSUES

IN THE

EU

Hans Van Bruggen, MSc

Senior Regulatory Affairs Consultant, eCTDconsultancy B.V., Netherlands

10:00-10:30

AM

REFRESHMENT BREAK

TRACK 2 (ADVANCED)

TRACK 1 (ESSENTIAL)
10:30

AM-12:00 PM

SESSION 4

STUDY TAGGING FILES: THEIR VITAL ROLE

IN

10:30

AM-12:00 PM

SESSION 4

CTD-ALIGNED SUBMISSION FORMATS

SUBMISSIONS

TO THE FDA
SESSION CHAIRPERSON

SESSION CHAIRPERSON

Virginia R. Ventura

eRegulatory Liaison
Roche Products Ltd., UK

Geoffrey Williams, PhD

Team Leader, Electronic Submission Support, Office of Business

Process Support, CDER, FDA

The ICH CTD structure has been used as the basis for a number of other
submissions on a worldwide basis. This session will look at three examples of such submission formats and describe how the applicant can
extend the experience gained with the use of the CTD and eCTD in the
US and EU to these submissions.

Utilization of the Study Tagging File (STF) is essential to preparing a

reviewable Module 4 or Module 5 submission to the FDA. However, the
STF can be complex and can been misunderstood. This session will
inform you of recent issues the FDA has observed in submitted STFs,
and industry experts will illustrate how they have corrected and avoided similar issues.

THE ACTD: AN ASIAN TWIST

ON THE

ICH STANDARD

Lalana Dararutana, RAC

FDAS PERSPECTIVE

ON THE

Senior Regulatory Product Consultant, Image Solutions Inc.

STUDY TAGGING FILE

Virginia R. Ventura

Team Leader, Electronic Submission Support, Office of Business

Process Support, CDER, FDA

THE EUROPEAN NON-eCTD ESUBMISSION SPECIFICATION (NEES)

Rob de Haan, PhD

Adjunct Directeur/Deputy Director, CBG-MEB, Netherlands

STFS

IN

ACTION: THE GOOD,

THE

BAD,

AND THE

UGLY

Brad Kim

THE CANADIAN CTA STANDARD

Director, Regulatory Operations, Image Solutions, Inc.

Vianney Caron

Project Lead, eReview, Therapeutic Products Directorate,

Health Canada

STF LIFE CYCLE PITFALLS: WHAT ARE THEY, WHY SHOULD YOU CARE,
AND HOW TO AVOID THEM
Amy Jo Holloway

Senior Regulatory Associate, Regulatory Information Management,

Eli Lilly and Company

Unless otherwise disclosed, DIA acknowledges that the 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 any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.

12:00-1:30

PM

LUNCHEON

TRACK 2 (ADVANCED)

TRACK 1 (ESSENTIAL)
1:30-3:00

SESSION 5

PM

1:30-3:00

PM

SESSION 5

NOT YOUR EVERY DAY eCTD

DIAS DOCUMENT REFERENCE MODEL

SESSION CHAIRPERSON

SESSION CHAIRPERSON

Matthew J. Neal

Laura J. Sherman, MBA

Director, Global Regulatory Affairs and Safety, Amgen Inc.

Managing Partner, Distributed Compliance Solutions LLC

This session will explore multiple topics ranging from the painless transition from active paper INDs to eCTD; submitting unique and interesting submissions such as the Drug Master Files, and ANDAs; suggestions
on eCTD under the hood cleanup that can assist in modern review
practices at the agency and life cycle management and presentation to
exploit the subtle nuance of eCTD guidance.

The Electronic Document Management (EDM) Reference model is a DIA

cross-SIAC initiative led by the Document and Records Management
(DRM) SIAC focusing on the development of a common taxonomy and
metadata base starting with submission document types. The model
aligns with strategic industry initiatives, is adaptable to emerging data
exchange standards, and is intended to be a business process enabler
alleviating challenges associated with streamlining the business process
as technology rapidly advances, regulatory requirements evolve, and
industry standards progress. This session will provide:

Discuss best practices and key learnings from experienced publishers

and submission managers for submissions that are not regular, frequent,
or clear in guidance or practice. Novel, and interesting approaches to
create eCTD and stay electronic and compliant.

AND

eCTD PUBLISHING

Project Manager, Regulatory Affairs, Octagon Research Solutions, Inc.

An overview and background on the model

A case study on how the model can close the gap between EDM architectural constraints and industry requirements to manage documents
and metadata for eCTD submissions
An industry perspective on ePublishing, emerging standards, and the model

DMF/ASMF eCTDS

EDM REFERENCE MODEL BACKGROUND

AVOIDING PITFALLS

WHEN

SUBMITTING

AN

ANDA

IN

eCTD FORMAT

Christopher Gutowski

AND

OVERVIEW

Edsel David

Taryn N. Stevens

Manager, Global Regulatory Operations, Pfizer

Senior Director, Knowledge Management, Daiichi Sankyo, Inc.

BEST PRACTICES LONG-TERM LIFECYCLE: CLEANING UP THE MESS

CASE STUDY: USING THE EDM REFERENCE MODEL TO CLOSE

BETWEEN REGULATORY/INDUSTRY REQUIREMENTS AND EDM
ARCHITECTURAL CONSTRAINTS

Monica Kennedy, RAC

Senior Manager, Global Regulatory Affairs and Safety, Amgen Inc.

THE

GAP

Anne Marra

CONVERTING PAPER INDS

TO

Senior Director, Regulatory Operations, NPS Pharmaceuticals

eCTD

Carrie Mazzrillo, MBA

MODEL PERSPECTIVE ON EPUBLISHING

STANDARDS INITIATIVES

Manager, Regulatory Submission Management, Eisai, Inc.

AND

EMERGING INDUSTRY

Antoinette Azevedo

President and CEO, e-SubmissionsSolutions.com

3:00

PM

CONFERENCE ADJOURNED

TRAVEL AND HOTEL: The most convenient airport is San Diego International
Airport and attendees should make airline reservations as early as possible to
ensure availability. The Westin San Diego Hotel is holding a block of rooms at
the reduced rate below until October 23, 2009, for the DIA event attendees.
Room availability at this rate is guaranteed only until this date or until the
block is filled.
Single

$179

Double

GROUP DISCOUNTS*: Register 3 individuals from the same company and receive
complimentary registration for a 4th! All 4 individuals must register and prepay at
the same time no exceptions. DIA will apply the value of the lowest applicable fee
to this complimentary registration; it does NOT include fees for optional events or
DIA membership. You may substitute group participants of the same membership
status at any time; however, administrative fees may be incurred. Group registration
is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.

$189

Please contact The Westin San Diego Hotel by telephone at +1.888.627.

9033 and mention the DIA event. The hotel is located at 400 West Broadway,
San Diego, CA 92101, USA.

To take advantage of this offer, please make a copy of this registration form for
EACH of the four registrants from your company. Include the names of all four
group registrants on each of the forms and return them together to DIA.

Participants with Disabilities: DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons
attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs.
8

Drug Information Association

www.diahome.org

MEMBER EARLY BIRD

SAVE $190

Register by OCTOBER 27, 2009

Tutorials: November 17, 2009

8th Annual Electronic

Submissions Conference

Morning 8:30

eCTD: The Adventure Continues

Conference: November 18-19, 2009

AM-12:00 PM

#1 EU Regulatory Review Procedures and Their Implications for eSubmissions Publishing

#2 INDs in eCTD Format
#3 eCTD Basics
Afternoon 1:30-5:00

PM

#4 US-EU eCTDs (Creating eCTDs for the US and EU): Differences and Similarities
#5 eCTD Life Cycle Management

The Westin San Diego Hotel

San Diego, CA, USA
Event ID #09026

#6 Metadata and Standards: How Metadata Is Used from Protocol Definition to

Regulatory Submission

Register online or fax this page to +1.215.442.6199

DRUG INFORMATION ASSOCIATION

800 Enterprise Road, Suite 200
Horsham, PA 19044-3595 USA

CONTACT & TABLETOP EXHIBIT INFORMATION

Attendees may visit the tabletop exhibits during the event and during receptions
(if applicable).
Event information: Contact Carrie Dunn at the DIA office by telephone +1.215.442.
6181, fax +1.215.442.6199 or email [email protected].
Tabletop exhibit information: Contact Shannon Lewis, Exhibits Associate, at the
DIA office by telephone +1.215.442.6149, fax +1.215.442.6199 or email Shannon.
[email protected]. For tabletop exhibit space, please check the box below.

 To receive a tabletop exhibit application, please check.

GROUP DISCOUNTS (not available online or on already discounted fees)
Register 3 individuals from the same company and receive complimentary registration
for a 4th! All 4 individuals must register and prepay at the same time no exceptions.
See page 5 for complete details.

Registration Fees If DIA cannot verify your membership upon receipt of registration
form, 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

Available on nondiscount member fee only

On or before
OCT. 27, 2009

US $1260

Member Fee

After
OCT. 27, 2009

US $1450

MEMBERSHIP

Join DIA now to qualify for the early-bird member fee!

Go to http://www.diahome.org/membership

US $ 140

US $1590

I do NOT want to be a DIA member

Discount Fees

NONMEMBER*

MEMBER

US $ 365
US $ 730

Government (Full-time)




US $ 505
US $ 870




Charitable Nonprofit/Academia (Full-time)

*If paying a nonmember fee, please check one box above, indicating whether you want membership.

TUTORIALS, Tuesday, November 17

#1

8:30 am-12:00 pm US $ 405

#2

8:30 am-12:00 pm US $ 405

#3

8:30 am-12:00 pm US $ 405





09026

PLEASE CONSIDER THIS FORM AN INVOICE

Please check the applicable category:

 Academia  Government  Industry  CSO  Student (Call for registration information)

Last Name

Check if part of group registration

First Name

M.I.

 Dr.

Degrees

 Mr.

 Ms.

Company

A one-year membership to DIA is available to those paying a NONMEMBER registration

fee. If paying a nonmember fee, please indicate if you do, or do not, want membership.

I want to be a DIA member

Do not remove mailing label. Please return this entire page.

Job Title

To qualify for the early-bird discount, registration form and accompanying payment must be
received by the date above. Does not apply to government/academia/nonprofit members.
Nonmember Fee

REGISTRATION FORM

#4

1:30-5:00 pm US $ 405

#5

1:30-5:00 pm US $ 405

#6

1:30-5:00 pm US $ 405





CANCELLATION POLICY: On or before NOVEMBER 9, 2009

Administrative fee that will be withheld from refund amount:
Member or Nonmember = $200
Government or Academia or Nonprofit (Member or Nonmember) = $100
Tutorial (if applicable) = $50
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 own hotel
and airline reservations. You may transfer your registration to a colleague at any time
but membership is not transferable. Please notify DIA of any such substitutions as soon
as possible. Substitute registrants will be responsible for nonmember fee, if applicable.
DIA reserves the right to alter the venue, if necessary. If an event is cancelled,
DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

Address As required for postal delivery to your location

City

Mail Stop
State

email

Zip/Postal

Country

Required for confirmation

Phone Number

Fax Number

Group Registrant #2 Last Name

First Name

Completed form required for each group registrant

Group Registrant #3 Last Name

First Name

Completed form required for each group registrant

Group Registrant #4 Last Name

First Name

Completed form required for each group registrant

PAYMENT OPTIONS

Card #

 MC

 AMEX

Exp Date

_______________________________________

_______________________________________________________________________________

Name (printed)
Signature

Register online at www.diahome.org or check payment method

CREDIT CARD number may be faxed to: +1-215-442-6199. You may prefer to pay by check or bank transfer since
non-U.S. credit card payment will be subject to the currency conversion rate at the time of the charge.

 Visa

Required for confirmation

_________________________________________________________________________

____________________________________________________________________________

CHECK drawn on a US bank payable to and mailed along with this form to: Drug Information Association Inc, P.O. Box
95000-1240, Philadelphia, PA 19195-1240, USA. Please include a copy of this registration form to facilitate identification
of attendee.
BANK TRANSFER When DIA completes your registration, an email will be sent to the address on the registration form
with instructions on how to complete the Bank Transfer. Payment should be made in US dollars. Your name and company,
as well as the Event I.D. # must be included on the transfer document to ensure payment to your account.