Title:
The 8th Annual Electronic Submissions Conference; eCTD: The Adventure Continues
Date(s) And Time(s):
Nov 17 2009 8:00AM - Nov 19 2009 12:00AM
Location:
Westin San Diego
400 West Broadway
San Diego, CA 92101
Interest Area(s):
Regulatory Affairs, Medical Writing, Project Management, Clinical Research
Overview:
Tutorials: November 17, 2009
Conference: November 18-19, 2009
Discuss Current Developments in eCTD in the US and Europe, Filing CTDformatted
Submissions in Other Markets, and Emerging Technologies
Affecting Electronic Submissions.
eCTD-formatted submissions have taken hold in the US and are on their way to doing the same in
Europe. Now eCTD is poised to become the preferred format for regulatory submissions in many
other regions, from South-central Asia to the Pacific Rim to Latin America. Australia and
Switzerland have both issued statements of intent to accept eCTD, while many other regions are
basing both paper and electronic submission formats on the CTD structure.
FEATURED TOPICS
Transitioning to eCTD
– Gradual transition or complete
re-engineering
– Benefits of pilot/sample eCTD projects
– In-house vs. outsourcing
– Business Process Planning
– Benefits of eCTD vs. paper
• eCTD Metrics
– Process improvements from eCTD
– Measuring eCTD success
– Measuring eCTD scope
• Varied Submission Types in eCTD Format
– IND/NDA/BLA/ANDA/MAA/NDS
– DMF/ASMF
– Annual Report/Renewal
– PSUR/DSUR
• Multi-regional eCTDs
– Assembly and management of eCTDs for
multiple regions
• CTD-Aligned (CTD-Influenced) Submissions
– ACTD
– NeeS
– Non-ICH eCTD/CTDs
• Lifecycle Management
– Within and across applications
– Legacy applications
– Challenges, issues and solutions
• Labeling
– SPL R4: Changes to labeling, drug establishment,
drug listing
– PIM
– Managing global labeling
• Data / Standards
– CDISC compliant data submissions
– Validating submission data
– SDTM/ADaM/SEND compliance
– Including CMC Data in eCTDs
• Summary and Report Writing for eCTDs
– Writing and re-using content across
submissions
– Granularity
• Project management for eCTDs
– Management of multinational eCTDs
– Managing against timelines
• Future Trends
– RPS V2
– HL7-CDISC Harmonization
– Electronic Health Records
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
· Discuss emerging and future trends in electronic submissions including Regulated Product Submission (RPS);
· Identify challenges and benefits of transitioning to eCTD;
· Identify the various methods of submitting electronic submissions to global health authorities;
· Create guidance-compliant INDs, NDAs, MAAs, NDSs, DMFs, and ANDAs in eCTD format to ensure acceptance and reviewability;
· Differentiate between “guidance” and “regulation” and their impact
· on the process;
· Recognize the vital role of good document management and best business practices in the overall process of preparing the eCTD; and
· Describe the role of eCTD standards and their impact to the development/delivery process.
Target Audience:
This program will benefit individuals involved in
· Regulatory Affairs/Operations
· Document and Data Management
· Technical and Medical Writing
· Project Management
· Information Technology
· Data Analysis/Management
Event Code:
09026
Contact Information:
Conference: Contact JoAnn Boileau at the DIA office in Horsham, PA by telephone +1-215-442-6175, fax +1-215-442-6199, or email joann.boileau@diahome.org.
Exhibits: Shannon Lewis, Phone +1-215-442-6149/email Shannon.Lewis@diahome.org