CDISC Overview
Shanghai China Thursday, 12 June 2008
08:30 am - 12:00 noon
The Clinical Data Interchange Standards Consortium (CDISC) will be sponsoring one 4-hour educational session in Shanghai, China, aimed to provide an overview of CDISC. The speakers will be Dr. Rebecca Kush, President and CEO of CDISC and Sandy Lei, Associate Director, Clinical Data Warehousing Statistical Computing Operation, Johnson & Johnson PRD.
The presentations will cover:
Background and History of CDISC
Overview, Benefits and Adoption of CDISC Standards
Global Standards Activities and Collaborations,
e.g. Regulatory Authorities, ISO, HL7, WHO
Overview of CDISC SDTM and ADaM Standards
Q&A
Discussion and Next Steps for China and CDISC
There is no charge for this event, however, due to space limitations, no more than two individuals from organization will be allowed to attend.
CDISC Japan Interchange
3 - 6 June 2008 Tokyo, Japan
3-4 June: Training (Tokyo Opera City Tower)
5-6 June: Conference (Aioi Sonpo Shinjuku Hall)
Improving, developing and integrating your e-Clinical systems…
As pharmaceutical companies aspire to manage fully integrated e-Clinical systems, there is no better time to attend ViB’s annual e-Clinical Trials meeting. The conference promises to tackle the complex issues of incorporating electronic systems, consolidating different data streams and how to successfully manage these disparate systems.
Furthermore, speakers
and delegates will also have the opportunity
to explore the different strategies when
conducting global trials and how to manage
EDC and other systems as the trial progresses.
Whether you are in the early phases of
e-Clinical development or you are looking
into growing your current e-Clinical programme,
ViB's e-Clinical Trials conference will
bring together the experiences of major
pharmaceutical companies to give practical
and adaptable examples of incorporating
electronic systems into clinical trials.
This is set to be one of the most comprehensive events this year, and will include a number of case-study presentations:
Astellas will discuss the standardisation issues in global EDC systems
Bayer and Wyeth will analyse at different ways of developing your current e-Clinical systems
Two speakers from Merck Serono will also look at how to optimise the relationship between site and sponsor
Novo Nordisk will explore the different solutions on how to join the various elements together to build a successful platform
19th Annual EuroMeeting
March 26-28 2007
Vienna, Austria
Share experiences with professionals from more than 50 countries at this neutral, global forum - The largest event of its kind in Europe, featuring 130 sessions in 24 tracks, more than 400 speakers from the EMEA, FDA, regulatory agencies throughout Europe and industry and academia. Also offering 20 pre-conference tutorials, student & professional poster sessions and multidisciplinary networking opportunities.
QT Issues in Drug Development the evolving science, practical issues, and regulatory implications
April 11 - 13 2007
Washington, DC, USA
Let regulatory, industry, and scientific thought leaders be your guide as you explore the evolving science surrounding drug development and cardiac repolarization.
Industry and Health Authority Conference on: Oligonucleotide-based Therapeutics
April 19 - 20 2007
Bethesda, MD, USA
Industry and health authorities come together to share product development and regulatory information in the areas of nonclinical, chemistry, manufacturing and control (CMC), and clinical development of oligonucleotide-based therapeutic drugs, including antisense, RNAi, immunostimulatory, and aptamer applications.
Clinical Research and Product Registration of Biopharmaceuticals/Vaccines in India and China
April 25 - 27 2007
San Diego, CA, USA
A detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China - East coast offering sold out in 2006, now offered on West coast!
FDA Public Workshop on Human Subject Protections and Bioresearch Monitoring
May 10 - 11 2007
Washington, DC, USA
Join us for the first-of-its-kind workshop on building in and implementing quality in modern clinical investigations from the inception of the research through its completion.
The First Conference in Japan for Asian New Drug Development
May 17 - 18 2007
Tokyo, Japan
The conference will focus on: Chinese regulation and infrastructure for clinical trials, Current status of regulation and trials in Asian countries, and Asian development strategy and clinical operations.
4th
CDISC European Interchange
Grand Hôtel Suisse Majestic, Montreux,
Switzerland
Training: 23-24 April 2007
Conference: 25-26 April 2007
Note: Registration
has closed.
IBC’s 17th International Conference
Antibody Engineering
Forging a Vision for the 21st Century
December 10-14, 2006 * San Diego Convention Center
Now entering its 17th year, IBC’s Antibody Engineering has attained a well-deserved reputation as the pre-eminent meeting of its type anywhere in the world. Over five days, you will have the opportunity to learn cutting edge developments in the field from an international speaker faculty of more than 50 leading scientists, to network with more than 700 colleagues and to see exhibits highlighting exciting new technologies that will improve the speed and quality of your work.
Best
Practices and Development of Standards
for the Submission of Genomic Data to
the FDA
27-28 November 2006
at the Washington Marriott Hotel, Washington,
DC. Link
for more information
The Quest to Enable the Electronic Clinical Trial:Finding Clarity in a Confusing World
In collaboration with DIA, ACRO, AMIA, CDISC, The CPath Institute, HL7 and SAFE
December 6-7, 2006
Sheraton Inner Harbor Hotel, Baltimore, MD, USA
5th Annual Electronic
Submissions Conference - eCTDs: Entering
the Mainstream
November 1 –
3, 2006
San Diego, CA
In response to
a growing demand for a comprehensive electronic
submission conference, this year’s
conference will be expanded to multiple
tracks. As more and more companies gain
experience or contemplate the transition
to electronic submissions, and as the
electronic submission environment changes,
it is imperative that the stakeholders
maintain open communication regarding
new regulations, guidance, and the experience
of the implementation.
The Third Multitrack
Workshop in Japan: How Could Companies,
Regulators and Academia Better Collaborate
in Pharmaceutical Development?
October 5 –
6, 2006
Tokyo, Japan
Three concurrent
tracks of content management, regulatory
and safety management, and biostatistics,
will discuss possible collaboration in
the most advanced topics. Track A: Invitation
to New Era of Data and Documents, covers
data management, medical writing and content
management. Track B: Collaboration to
Fulfill Our Joint Mission of Delivering
to Patients Medications of Greater Efficacy
and Greater Safety with Greater Speed,
areas of regulatory affairs, safety management
and pharmacovigilance will be discussed.
Track C: Value-added Contribution of Biostatistics
to Drug Development, topics in biostatistics
will be discussed. All meeting participants
will be able to attend sessions in any
of these tracks.
Webinar
- Overview of Regulatory Affairs Personnel
on the Requirements for Submission of
Clinical Data for New Drug Applications
(NDAs)
October 5th, 2006
Working with the PhRMA Study Data Tabulation
Model (SDTM) Best Practices Group, DIA
is hosting a webinar titled an "Overview of Regulatory
Affairs Personnel on the Requirements
for Submission of Clinical Data for New
Drug Applications (NDAs)" on October 5th,
2006. This webinar is designed to
give Regulatory Affairs personnel and
their management an understanding of how
to interpret expectations of FDA management
regarding clinical data submissions, recognize
the impact of these expectations on technical
staff, assess whom to include in discussions
addressing issues related to clinical
data submission, evaluate requests from
FDA reviewers, and recognize the impact
of training and tools available at FDA
for reviewers.
For registration, click
here and enter keyword 06246.
DIA Outsourcing Summit
September 26 - 27, 2006
Philadelphia, PA
The DIA outsourcing summit is designed to bring
together executives and operational personnel
from biotechnology and pharmaceutical companies,
service providers, and study sites to benchmark
best practices and engage in discussions on
how to achieve greater value from outsourcing.
The goal is to enable participants to share
insights and experiences and to examine how
to apply these concepts to their own projects
and corporate culture.
“Data on Demand”:
Optimization of CDM
September 26 - 27, 2006
Philadelphia, PA
Learn the techniques for optimizing the CDM
process, including integration and utilization
of database/warehousing technologies with data
capture solutions – in both hosted and
non-hosted computer environments, emphasis on
data capture technicians, data review for rapid
decision making.
Global Electronic Labeling
September 26 - 27, 2006
Philadelphia, PA
Join your peers to discuss lessons learned
from implementing PIM and SPL; Hear from the
Health Authorities who are utilizing them; Share
strategies for managing global labeling components;
and find out what potential impacts the Physician’s
Labeling Rule will have on the content of labeling.
Pre-registration is closed. You must
now register at the event.
Interchange Hotel
Marriott Bethesda North
5701 Marinelli Road
North Bethesda, Maryland 20852 USA
Phone: 1-301-822-9200
Toll-free: 1-800-859-8003
NOTE: The conference hotel
is completely full. There is availability
at the Bethesda Marriott (301-897-9400) and
Bethesda Marriott Suites (301-897-5600)
2nd Annual Merging Electronic
Health Records & Electronic Data Capture
Integrating Patient Information with Drug Development
09-18-2006/ 09-19-2006
Four Points by Sheraton
Washington, DC For
details click here
Clinical Research and
Drug Registration in China and India
September 18 - 19, 2006
Princeton, NJ
This conference offers a detailed analysis
of what it takes to conduct clinical trials
in China and India, and will address: risk/benefit
balance; anecdotal experiences of the multinational
pharmaceutical industry in China and India;
selection and role of CROs; logistics of operations;
clinical trials management; government policies
(including IPR issues); and pharmacovigilance.
Update on the CDISC Business
Case for Industry Data Standards
Wednesday, 16 August 2006 For
details click here
Learn the process and progress to
date on the CDISC Business Case Project
Review metrics and findings of the
project to date
Discuss the findings in from present
implementations and their areas of use
The
Biomedical Research Integrated Domain Group
(BRIDG) Model
Wednesday, 26 July 2006 For
details click here
Understand the purpose of a domain analysis
model
Gain an understanding of the history, progress
and current status of the BRIDG model
Learn how the CDISC and HL7 standards are
represented in the model
Learn the benefit of the UML modeling from
the perspective of trial design
2nd CDISC Japan Interchange
11-13 July 2006
Nagai Memorial Hall
Tokyo For
more information
DIA 42nd Annual Meeting
June 18-22, Philadelphia, PA For
more information
Attend presentations and case studies from more
than 1,000 speakers; Hear representatives from
the FDA, EMEA and other regulatory agencies;
Choose from sessions in 29 tracks offered over
3½ days; Network with over 450 exhibiting
companies; Attend one of 40+ preconference tutorials;
Participate in the Networking Reception at the
National Constitution Center ; Visit student
and professional poster sessions; Keynote presentation
by Sanjay Gupta, MD Senior Medical Correspondent
for CNN.
Why Clinical Development
Team Should Care about Data Standards
Thursday, 8 June 2006 POSTPONED
UNTIL FURTHER NOTICE
Part III: Real World Experiences with the ODM For
more information
Real-life experiences of using the ODM to
support the submission of clinical trial data
Why this important to pharmaceutical companies
Why this is wanted by the agency
NIH ROADMAP INVENTORY
AND EVALUATION OF CLINICAL RESEARCH NETWORKS
(IECRN) NATIONAL LEADERSHIP FORUM
May 31 and June 1, 2006
DoubleTree Hotel
Rockville, Maryland
(No registration fee, webcast available)
Another View of eCRF
– Hybrid solution: Oracle Clinical Wednesday May 24, 2006,
8:30 am to 12:00 pm, Hyatt Regency Princeton
- Princeton, NJ
Thursday May 25, 2006, 8:30 am to 12:00 pm,
Hotel MIT - Cambridge, MA
This interactive workshop will provide an overview
of the Data Management aspects of performing
clinical studies with eCRFs, the theoretical
background, and current solutions in this field,
with focus on the practicability in concrete
clinical studies.
6th Annual eClinical Trials
Conference
Tuesday 23 May & Wednesday 24 May 2006 Streamlining electronic systems to improve
data management for clinical trials
London, UK
For information, click
here
Register your interest at: www.clinicaltrialsevents.com
Why
Clinical Development Teams Should Care about
Data Standards
Thursday, 18 May 2006
Part II: The Inner Workings of the ODM Information is forthcoming
Learn about the structure of the ODM and
its extension mechanism
How the extension mechanism has been used
in Case Report Tabulation Data Definition
Standard (CRT DDS aka define.xml)
How define.xml supports the submission of
trial metadata and supports the CDISC Study
Data Tabulation Model (SDTM)
Preview extensions to support the submission
of data and the WHO clinical trial registry
Why
Clinical Development Teams Should Care about
Data Standards
Tuesday, 2 May 2006
Part I: An Introduction to the CDISC Operational
Data Model (ODM) For
details and registration click here
Gain an understanding of how standards can
be used from protocol through submission
Learn how standards will be central to the
FDA Critical Path
Acquire a basic understanding of the CDISC
transport standard, the ODM
Find out how the ODM has been used to render
views of eCRFs
Learn to use the ODM to archive electronic
data in compliance with 21CFR11
Discover how this work can help link clinical
research with healthcare (EHRs)
CDISC
2006 European Interchange
24-27 April
Berlin, Germany For more
information
Global Trial Bank--Meeting the Needs of the
International Biopharma Community and the Patients
it Serves
Wednesday, 19 April 2006 Click
here for more information
Learn the purpose and value of a global
trial bank
Hear vision and status of this initiative
Hear how the global trial bank project augments
the WHO International Clinical Trial Registry
Platform (ICTRP) Project
The Second Multitrack Workshop in Japan
April 13 – 14, Tokyo, Japan For
more information
This meeting will focus on ways to develop a
drug development strategy and how to handle
clinical trials. The content will include regulatory
issues as well as clinical research itself.
A plenary session, which will include a keynote
presentation by a drug development specialist
and an opening panel discussion, will begin
the meeting.
Three concurrent tracks will provide opportunities
for discussion of a variety of issues for research,
planning and implementation in drug development.
Considerations for establishing the interoperability
for SDTM and ADaM FOR A submission
Models that are being evaluated for the
parallel paths of observed, derived and analyzed
data
Structuring an electronic submission for
FDA review and approval using the ICH E3 and
the eCTD
Life
Sciences Conference & Expo (www.lifesciencesexpo.com)
Co-organized by Bio-IT
World and the Massachusetts Biotechnology Council
April
3-5, 2006
The Sheraton Boston Hotel
39 Dalton St
Boston, MA 02199
Don’t miss Bio-IT
World’s fifth annual Life Sciences Conference
and Expo this coming April in Boston. Four outstanding
conference tracks, award presentations and educational
workshops for Life Science and IT Professionals.
Sign up today for this three-day program and save 25% when you use priority
code BTR235. Click
here for more information.
Program: E-Clinical Research
& Trials
21st
Annual Clinical Data Management Symposium and
Exhibition
March 26 – 29, Philadelphia, PA For
more information
DIA has taken a fresh approach to this year’s
meeting and are presenting a combination of
new topics along with some of our ever-popular
standard Data Management topics. The conference
is organized in three parallel tracks:
· Data Management Fundamentals
· Managing Data Management
· Data Management – Other Perspectives
* * co-located with * *
R&D MEETS HIT Using
Electronic Health Records to Streamline Clinical
Trial Operations: Healthcare IT Transforming
Drug Development
March 26-29, Philadelphia, PA For
more information
In collaboration with Healthcare Information
and Management Systems Society "HIMSS"
The availability and accessibility of managed
healthcare information and data emanating from
claims clearinghouses, electronic transaction
companies and electronic medical record (EMR)/electronic
healthcare record (EHR) vendors is bringing
significant change to the recruitment paradigm.
All healthcare stakeholders will be impacted
by the emergence of regional healthcare information
organizations (RHIOs) throughout the country
and the potential for a powerful source of integrated,
longitudinal patient data. This change is expected
to reduce the time required to recruit and enroll
patients from months to weeks and boost investigator
participation. These new data-partnership phenomena
– positioning electronic medical record
providers and other healthcare data aggregators
with clinical trial sponsors – is quickening
the transition to an electronic approach that
will significantly speed time to market.
DIA
Webinar: eSUBs and eCTD Basics
March 23 11:00AM – 12:30PM EST For
more information
This webinar will present a brief history of
electronic submissions from the 1999 eSUB guidances
to the October 2005 eCTD guidance, explain the
key elements for compilation of an IND in eCTD
format, including preparation of e-submission-compliant
PDF files, and describe the transition from
IND as eCTD to NDA as eCTD. This webinar will
conclude with a Q&A in which participants
are encouraged to submit questions through an
anonymous, computerized Q&A function to
the panel of speakers.
2006
Annual Workshop on Statistical Methodologies
in the Biopharmaceutical Sciences
March 13 – 15, Washington, DC For
more information
The Annual DIA Statistics Workshop provides
an important, open forum for statisticians and
clinicians from industry, academia, CROs and
regulatory agencies to learn about, discuss
and debate current and emerging statistical
methodologies and quantitative approaches used
by sponsors to provide evidence for the approval
of new medical products.
* * back-to-back with * *
Data Mining in Pharmacovigilance:
Help or Hype?
March 16, Washington, DC For
more information
Join us for this one-day meeting which will
incorporate speaker presentations and live vendor
demonstrations on known issues in drug safety,
along with data mining/signal detection software,
analysis, and results! Primary topics include
Overview of data mining, Comprehensive review
of signal detection strategies, Integrating
data mining within a comprehensive signal detection
program: A large pharmaceutical company perspective,
Utility of data mining for small-medium pharmaceutical
companies, and Presentations by vendors of software
and/or data analysis services with proprietary
software.
WHO International Trial
Registry Platform (audio seminar)
Thursday, 16 March 2006
10:30 am - 11:30 am CST For
more information
Learn the purpose and value of registering
all clinical trials at inception
Hear a status update on the progress of
the International Clinical Trials Registry
Platform project
Gain a thorough understanding of the project
goals going forward
Hear how CDISC and HL7 are involved in this
project
2005
Past Meetings and Presentations -- 2005
Please join us at The
Merging Electronic Health Records &
Electronic Data Capture Conference taking place November
14-16 at the Hyatt Regency in Reston, VA.
This conference is designed to explore the
opportunity for collaboration with drug
and device firms in accelerating IT adoption
by hospitals and physicians and brings together
industry thought leaders to discuss integrating
patient information with drug development.
The conference features several key discussion
points including:
1. Reducing the Adoption Gap: How Can Drug
& Device Companies Drive User Adoption of
Electronic Records in the Healthcare System?
2. Hospital Perspective: The Challenges and
Limitation of Merging Electronic Health Information
Opening Communication Streams: Utilizing IT
to Gather & Disperse Information
3. Interchange Standards: The Key to Linking
Healthcare and Clinical Research Information
4. How Much Value Does EHR Really Have to Drug
& Device Companies
5. Analyzing the Progress and Data-Sharing
between Clinical Care & Clinical Research
Domains
For more information on the impressive speaking
faculty and topics to be discussed please click
here.
As a partner at this event, CDISC is pleased
to offer a 20% discount on the registration
fee. To claim your 20% discount on the registration
fee, please click
here and use the Registration and Discount Code CDISC.
Key
Challenges and Solutions in the Development
of Therapeutic Products- best practices in small
and large companies
November 6-8, 2005
Hyatt Regency Islandia Hotel & Marina
San Diego, CA
Attendees of this conference will learn the
importance of establishing processes for ensuring
compliance with FDA safety and risk management
initiatives, identify situations for the use
of Data Monitoring Committees and Data Safety
Monitoring Boards, distinguish innovative approaches
in clinical research: methods, standards and
technology, and recognize challenges related
to product development and their solutions .
To learn more and to fill out a registration
form, please visit http://www.diahome.org/Content/Events/05022.pdf
Japan
Pharmaceutical Development: Regulatory Perspectives
to Meet Simultaneous Global Drug Development
November 3, 2005
Park Hyatt Philadelphia at the Bellevue
Philadelphia, PA
This workshop is ideal for those who are new
to Japan pharmaceutical development and have
limited understanding of Japan and its regulatory
environment and drug approval process. The objectives
of this workshop are to open the dialogue between
regulatory authorities and pharmaceutical companies.
Since there were new Japanese regulations that
took effect on April 1, 2005, this workshop
provides a timely opportunity for professionals
who have experiences with successful Japanese
pharmaceutical development to exchange information
and lessons learned. To learn more and to fill
out a registration form, please visit http://www.diahome.org/Content/Events/05032.pdf
2nd
Annual CDISC European Interchange
Holiday Inn Bussy St.
Georges, (Paris) France 25-29 April 2005
To receive the 25%
discount, please register by February 27, 2004
with the exclusive CDISC Member PRIORITY CODE:
EXH4.
Delegates from major pharmaceutical, biotechnology,
government and academic organizations will have
the opportunity to learn about the latest tools,
services and training that fuel bio-IT, enabling
advances in genomics, proteomics, drug discovery,
through to clinical trials and evidence-based
medicine.
2005
WORKSHOPS: Essential SOPs and Documentation
for CDM
Georgetown University Marriott Conference Center,
Washington DC 12 & 13 April 2005
For further information or to download a brochure
please go to our website www.rcwg.org or contact our Registration Manager (Sharon
Thomas) Tel: 301.552.8741; Fax: 301.552.9536;
Email:RCWG@Comcast.net
2nd
Annual CDISC European Interchange
25-29 April 2005
Holiday Inn Bussy St. Georges
39 Boulevard de Lagny
77600 Bussy Saint Georges (Paris)
France
CDISC-HL7 Day
Georgetown University
Marriott Conference Center, Washington DC 12 & 13 April 2005
For further information or to download a brochure
please go to our website www.rcwg.org or contact our Registration Manager (Sharon
Thomas) Tel: 301.552.8741; Fax: 301.552.9536;
Email:RCWG@Comcast.net
CDISC-HL7 Day 29 April 2005
Holiday Inn Bussy St. George
Following the CDISC European Interchange
Preliminary Program (pdf)
CDISC
Featured Presentation at eSubmissions 2004, to
be held in Washington DC, January 26-28.
Web address for the conference is www.iirusa.com/esubs2004 See
brochure
26-28 January
2004 - Institute for International Research
USA
"Partnering with Central Labs,
ECG, and Imaging Core Labs"
Harrah's, Las Vegas, NV
25-27 February
2004 - “The Meeting Place for Clinical
Decision Makers”
Wyndham Franklin Plaza Hotel, Philadelphia,
PA
Overview
Clinical Trial Congress’ mission is to
be one of the world’s largest meeting
places for clinical decision-makers. CTC offers
best practice strategies on streamlining clinical
development through effective planning of budgets
and timelines, maximizing return-on-clinical
investments, and maintaining compliance with
changing global regulations. More specifically,
the program agenda explores how pharmaceutical
companies can best conduct clinical trials to
ensure business growth and to get the most out
of the resources, technologies and partnerships
involved in clinical trials. Clinical Trials
Congress also helps you identify those commercial
opportunities, via internal or external resources,
that help position your drug candidates into
the right development strategy. Interactive
discussions with a controversial spin sets CTC
apart from the rest as a truly "unique"
conference experience. For more information,
e-mail: khunter@IIRUSA.com or mpalombini@iirusa.com
Stay
up-to-date with Event Developments &
Save 25% on CTC 2004
Subscribe for Clinical Trials Congress Event
Updates before September
15, 2003 and you ***will
receive 25% discount*** coupon valid
for CTC 2004 event only. Eligibility for the
discount includes submission of complete and
correct contact information. This offer is only
available for those who subscribe before September
15, 2003. Your discount letter including customized
code will be mailed to you. Subscribe
Here
Clinical Trials Congress
February 25-27, 2004
Loews Hotel, Philadelphia, PA www.clinicalevent.com
Tuesday, March 2, 2004
Hyatt Regency New Brunswick
2 Albany St.
New Brunswick, NJ 08901
Tel: 732-873-1234
Fax: 732-873-1382
8:30 a.m. - 12:00 p.m. (lunch optional)
Thursday, March 4, 2004
San Diego Marriott La Jolla
4240 La Jolla Village Drive
La Jolla, CA 92037
Phone: 1 858-587-1414
Fax: 1 858-546-8518
8:30 - 12:00 p.m. (lunch optional)
FEATURED INDUSTRY SPEAKERS
Russell Ellison, M.D., Vice President of Medical
Affairs, Sanofi-Synthelabo
Rebecca Kush, Ph.D., Founder and President of
CDISC
Charles Jaffe, M.D., Ph.D., Director of Medical
Informatics and Chief Medical Information Officer,
AstraZeneca
Attendees will gain a better understanding
of how to drive measurable value from an integrated
approach to eClinical that marries best practice
strategies and the latest technologies. FCG
and SAS will present the first solution of its
kind to offer a cohesive suite of tools to support
the entire drug development lifecycle, with
lower total cost-of-ownership and faster process
execution.
This is one of the only events that addresses
the entire process of managing trials –
from developing an upfront value-driven plan
for eClinical efforts, through the exchange
and integration of data, tools and business
processes. If you’re looking to increase
speed to market and reduce total costs this
is the event for you.
