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10110 11th Conference on European Electronic Document Management
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Title: 11th Conference on European Electronic Document Management
Date(s) And Time(s): Dec 1 2010 7:00AM - Dec 3 2010 5:00PM
Location: Hotel Le Meridien
1 Promenade Des Anglais
F- 06046 Nice
FRANCE
Interest Area(s): Clinical Data Management/ eClinical,CMC,Clinical Research,Document Management/ eSubmissions,IT/Validation,Medical Writing,Strategic Planning,Quality Assurance/Quality Control,Regulatory Affairs
Overview:
In an evolutionary environment, it seems that every time one overcomes a hurdle one discovers a whole new world to conquer. Similarly, in EDM we are discovering new frontiers. While on the regulatory submissions front, CTD and eCTD are now well known and understood and thousands of submissions are managed as eCTDs within stable EDM technologies, new horizons unfold ahead of us: Electronic gateways and advanced submission standards such as CDISC and RPS that extend the capabilities and flexibility of information exchange, new approaches for Enterprise Information Management, simpler and more affordable tools allowing compliant EDM for small corporations, collaborative and component-based authoring and new, powerful user interfaces are only some of the emerging novelties. Additionally, information sharing in the public domain has reached previously unthinkable levels and new techniques of information management are needed to handle both the disclosure and analysis of this new information “eldorado”.
Credits:
The Swiss Association of Pharmaceutical Professionals (SwAPP) and the Swiss Society for Pharmaceutical Medicine (SGPM) have accredited this meeting with 12 credits.
Learning Objectives:
• Operating and implementing EDMS technologies • Leveraging technologies for quality and efficiency • Best practices in managing the document lifecycle • Distinctions between Electronic Document Management and Electronic Information Management • Using metadata standards in the use and re-use of regulatory information • XML developments and XML implementation • Preparing eCTD filings for different European procedures • 2010 into 2011 - Current agency experience and requirements • Current and future submission formats
Target Audience: • Document and eRecords Managers • Standards Implementation Specialists and Associates • Regulatory Affairs Representatives • Regulatory/Clinical Operations Representatives • Quality Assurance and Compliance Professionals • Medical & Technical Writers • IT and Support Personnel • Contract Researchers and Service Support Providers • Academic Researchers • Validation Professionals • Pharmacovigilance Professionals • Knowledge / IP Professionals
Event Code: 10110
Contact Information:
DIA EUROPE
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-MAIL: DIAEUROPE@DIAEUROPE.ORG
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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 disclosures will be included in the course materials.
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 | Tutorial: eTMF MIGRATING FROM PAPER TRIAL MASTER FILES TO ELECTRONIC |
| Date & Time: Wednesday, Dec 1 2010 9:00AM - 5:00PM
Instructor(s): Eldin Rammell, Managing Director & Principal Consultant Rammell Consulting Ltd, United Kingdom
Karen Jane Redding, MPharm Global Director, Business Development Phlexglobal Limited, United Kingdom
Description:
This tutorial will provide a comprehensive overview of the issues involved in implementing an electronic trial master file. In addition to covering foundation principles such as “what is the trial master file”, this interactive session will provide guidance in a wide range of related aspects, including:
• what do the regulations say about eTMFs • how should documents be filed in an eTMF • metadata and naming conventions • what formats are acceptable • how can the eTMF be reviewed by end-users, auditors and inspectors • how can an eTMF support global clinical trials • how is the eTMF populated and maintained • what are the validation requirements • does an eTMF need electronic signatures
Learning Objectives: LEARNING OBJECTIVES At the conclusion of this tutorial, participants should be able to: • implement practical planning • recognize the principal regulatory requirements • understand different approaches to eTMF design • develop useful user requirements for an eTMF • recognize the impact of an eTMF on trial-related processes • evaluate potential IT solutions
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 | Tutorial: eSUBMISSION - A HIGHLIGHT OF THE DIFFERENCES |
| Date & Time: Wednesday, Dec 1 2010 9:00AM - 5:00PM
Instructor(s): Hans Van Bruggen, MSc
eCTDconsultancy B.V., Netherlands
Joris Kampmeijer, Information Processing Department Medicines Evaluation Board , Netherlands
Description: This tutorial is currently in development Please visit www.diahome.org > click on the EDM icon for regular programme updates
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10110 11th Conference on European Electronic Document Management Nice 2010
Fee: 3m x 2m booth space......... EUR 2'990.00 (inclusive of 19.6% French VAT)
Booth Rental Fee includes (per 3m x 2m booth space): Please Note: Space only; There will be NO pre-fitted shell scheme provided. • One (1) complimentary full-meeting registration; • One (1) complimentary exhibit booth personnel registration; • One (1) electrical connection; • One (1) table; • Two (2) chairs;
Additional expenses associated with the exhibit, including special booths, drayage, additional lighting, phone, internet connection, carpeting, additional electrical connections, etc., will be the responsibility of the exhibitor, unless otherwise noted. Any additional staff required above those allocated per 3m x 2m space must register as a full attendee incurring full registration fees.
Exhibit Show Dates: December 1-3, 2010 Hotel Le Méridien Nice, FRANCE
DIA Contact Information: Natacha Scholl Exhibits Manager, Europe +41 61 225 51 59 Natacha.Scholl@diaeurope.org
Useful Links: • Application & Contract for Exhibit Space • Floor Plan
Exhibiting Companies:
 | Bioscience2 |
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 | CSC |
| PA ,
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 | DoubleBridge Technologies, Inc. |
| NJ ,
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 | Exalon GmbH |
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 | EXTEDO GmbH |
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 | fme AG |
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 | Global Vision Inc. |
| QC ,
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 | Gxpi Ltd. |
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 | LORENZ International LLC |
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 | NextDocs |
| PA ,
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 | NNIT |
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 | Phlexglobal Limited |
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 | QUMAS |
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The DIA has blocked a number of rooms at the: Hotel Le Meridien Nice - France 1, Promenade des Anglais, 06046 Nice - France Phone: +33 4 97 03 44 44 Fax: +33 4 97 03 44 45 at the special rate of: EUR 135.00 per classic standard single room inclusive breakfast, tax, services, VAT plus tourist tax of EUR 1.20 per day.
To make your reservation: http://www.starwoodmeeting.com/Book/11thDIA
Important: Please complete your reservations by 31 October 2010. Cancellation Policy: Cancellation of the hotel booking must be in writing directly to the hotel. Your reservation can be cancelled until 8 days prior arrival date with no penalty. All no shows will be billed for the entire stay.
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Meeting
| Member Standard | €1165.00 | | Member Standard (As of 10/20/2010) | €1365.00 | | NonMember Standard | €1480.00 | | Member Academia | €1024.00 | | NonMember Academia | €1139.00 | | Member Government | €683.00 | | NonMember Government | €798.00 | | One Day Rate Member Government | €410.00 | | One Day Rate Member Academia | €614.00 | | One Day Rate Member Industry | €819.00 | | One Day Rate NonMember Academia | €729.00 | | One Day Rate NonMember Government | €525.00 | | One Day Rate NonMember Industry | €934.00 |
Additional Offerings:
| Tutorial: eTMF MIGRATING FROM PAPER TRIAL MASTER F - Standard Rate | €550.00 | | Tutorial: eSUBMISSION - A HIGHLIGHT OF THE DIFFERE - Standard Rate | €550.00 |
Group Discounts:
Group Discounts Available – Send 3 participants and the 4th is free!
Conditions apply. Online registration not available for this offer. Call DIA in Europe on +41 61 225 51 51 or email for further information.
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