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11TH CONFERENCE ON EUROPEAN ELECTRONIC DOCUMENT MANAGEMENT & EXHIBITION
1-3 December 2010 | Le Méridien, Nice, France
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.”
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
Who Should Attend:
- 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
Click here to register
Exhibition Opportunity Available!
For more information, please contact Natacha Scholl at +41 61 225 51 59 or email: exhibition@diaeurope.org |
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NEW TRIAL MASTER (TMF) REFERENCE MODEL
The Trial Master File Reference Model is a collaborative effort of 120 representatives from 75 biopharmaceutical companies, contract research organizations, consultancies, technical vendors, and regulatory agencies. This model consists of standardized taxonomy and metadata and outlines the clear definition and organization of TMF content using standard nomenclature. The Model provides an opportunity for standardization across the industry, and can be used by any company in an electronic or paper format.
Guide to TMF Reference Model
EDM REFERENCE MODEL
The EDM Reference Model is a document management initiative aimed at developing a taxonomy/metadata reference model that can ultimately be shared by biopharmaceutical organizations as a common starting point for building sustainable, shareable EDM repositories.
Guide to EDM Reference Model
FREE WEBINAR
Why You Need to Know About the EDM Reference Model
This free webinar is sponsored by the DIA Document and Records Management SIAC Working Group.
FEATURED TOPICS
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Efficiency and Cost Savings
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Streamlined and Cost-effective Business Processes between Pharma and its Service Providers
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Reduced Work Required to Integrate Content for Mergers and Product Acquisitions
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Affordability of EDM System Implementation
Click here to register. |
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