The Westin San Diego Hotel , San Diego, CA, USA
Nov 16 2011 8:30AM - Nov 17 2011 5:00PM
CALL FOR ABSTRACTS Please submit all abstracts using the online form at:
http://www.diahome.org/DIAHOME/GetInvolved/AbstractSubmissionLauncher.aspx
All abstracts must be received by JULY 11, 2011.
Abstracts will be reviewed and authors will be notified of results by AUGUST 1, 2011. SUGGESTED ABSTRACT TOPICS
• Validation Criteria
– Technical
– Challenges with publishing software and using multiple validators
– Business Rules
• Electronic DDMAC Submissions
– Effects on DDMAC of Transitioning from paper to electronic
– Case Studies
– Sponsor strategies moving from a paper/semi-paper process to fully electronic process
– Scale-up of Regulatory operational support for DDMAC Submissions
– Internal (sponsor) and External (agency) Impact
• Regulated Product Submission (RPS)
– Industry readiness
– Implementation goals
• Global Submission Management
• Collaboration
– Authoring
– Archiving
– Global Submissions
– Registration Tracking
• Clinical and Non-Clinical Standards
– CDISC, SDTM, SEND
• Mergers and Acquisitions
– Challenges
– Due-diligence
– Interoperability
– Best practices
– In-licensing/Out-licensing
– Case studies
This program was developed by the DIA DOCUMENT AND RECORDS MANAGEMENT, ECLINICAL, ELECTRONIC REGULATORY SUBMISSIONS, MEDICAL WRITING, AND REGULATORY AFFAIRS Special Interest Area Community.
As eCTD has matured and been implemented in many global markets, it has also raised expectations and scrutiny of data standards, caused an increase in the amount of regional requirements, and created the need for additional validators. Now that DDMAC submissions will be accepted in eCTD format by FDA in 2012, and are also being included in scope for RPS submissions, there are many challenges that befall both industry and agency to comply and scale-up their operations in support of the new guidance. This year’s conference will feature collaborative working sessions on specific topics and ICH modules that will give you the opportunity to interact and share the challenges you face and discuss how to overcome them. Event Code:
11026
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