The Drug Information Association will host the 8th Annual Electronic Submissions Conference from November 17- 19, 2009 in San Diego, CA.
Horsham, PA (Vocus) October 8, 2009 -- The Drug Information Association (DIA) will host the 8th Annual Electronic Submissions Conference from November 17- 19, 2009 in San Diego, CA.
Electronic CTD is poised to become the preferred format for regulatory submissions in many 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. This three-day conference will include two parallel tracks featuring the following sessions:
- Efficient Creation of eCTD Content
- Changing Your business Model to Get the Most Out of Your eCTD
- Submission Project Management
- Study Tagging Files: Their Vital Role in Submissions to FDA
- Not Your Everyday eCTD
- Perspectives on CDISC: Standards for Data and Metadata in Submissions
- Advanced Lifecycle Management
- CTD-Aligned Submission Formats
- DIA'S Document Reference Model and eCTD Publishing
In addition, six concurrent pre-conference tutorials on November 17 will cover:
- EU Regulatory Review Procedures and Their Implications for eSubmissions Publishing
- INDs in eCTD Format
- eCTD Basics
- US-EU eCTDs (Creating eCTDs for the US and EU): Differences and Similarities
- eCTD Lifecycle Management
- Metadata and Standards: How Metadata Is Used from Protocol Definition to Regulatory Submission
The opening plenary sessions will feature speakers from FDA, the European Union, and Health Canada to present up-to-date information on FDA's standards, expectations, and experiences with eCTDs, as well as plans for eCTDs and eSubmissions in the US, EU, and Canada.
"Electronic CTD-formatted submissions have taken hold in the US and are on their way to doing the same in Europe," says Gary M. Gensinger, MBA, Deputy Director, Office of Business Process Support, CDER, FDA. "The 8th Annual Electronic Submissions Conference will discuss current developments in eCTD in the US and Europe, filing CTD-formatted submissions in other markets, and emerging technologies affecting electronic submissions."
Click here to register.
For exhibiting opportunities, contact Shannon Lewis at +1-215-442-6149 or Shannon.Lewis(at)diahome.org.
About the Drug Information Association (DIA)
DIA serves more than 30,000 professionals involved in the biopharmaceutical industry and regulatory affairs worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA, USA, and with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China, the Association is led by its volunteer-based Board of Directors and executive management team. For more information, visit www.diahome.org or call 215-442-6100.
Joe (dot) Krasowski (at) diahome (dot) org
Read the full story at http://www.prweb.com/releases/DIA/Electronic_CTD/prweb3021654.htm.
Related medicine news :1
Copyright©2009 Vocus, Inc.
All rights reserved
. High Desert Medical Group, CEO Dr. Richard Merkin, Host Over 4,000 Seniors at 19th Annual Senior Health Expo, Discuss Savings Using Electronic Medical Records...2
. Satellite Healthcare Partners With the National Kidney Foundation for the 21st Annual San Francisco Authors Luncheon3
. The 24th Annual Great Sports Legends Dinner Raises More Than $6.3 Million for the Buoniconti Fund to Cure Paralysis4
. The American Society of Human Genetics to Host Press Briefing on 'Personalized Medicine and the Future of Health Care Practice' at 59th Annual Meeting 5
. Annual Scrapbooking Event in Oceanside October 17 and 18 to Benefit Susan G. Komen for the Cure6
. Super Jake Foundation Hosts 5th Annual Heroes Bash on Nov. 14 to Benefit Pediatric Cancer Research7
. CCMC Celebrates Case Management Week (Oct. 11-17) With Second Annual Patricia McCollom Scholarship8
. ADA Culminates Yearlong 150th Anniversary Observance at Its 150th Annual Session9
. ADAs 2009 Gold Medal Award Presentation Set for 150th Annual Session10
. More than 500 Breast Cancer Survivors and Community Supporters to Attend Annual 'Praise is The Cure' Event 11
. Massachusetts Nurses Association Votes to Join RN Super Union at Annual Convention