DIA 2010 - 11th Conference on European Electronic Document Management

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-AT-DIAEUROPE.ORG