Navigation Links
DIA 8th Annual Electronic Submissions Conference Addresses Current Developments in eCTD around the World

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)

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 or call 215-442-6100.

Joe Krasowski
Joe (dot) Krasowski (at) diahome (dot) org


Read the full story at

Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related medicine news :

1. 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 Luncheon
3. The 24th Annual Great Sports Legends Dinner Raises More Than $6.3 Million for the Buoniconti Fund to Cure Paralysis
4. 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 Cure
6. Super Jake Foundation Hosts 5th Annual Heroes Bash on Nov. 14 to Benefit Pediatric Cancer Research
7. CCMC Celebrates Case Management Week (Oct. 11-17) With Second Annual Patricia McCollom Scholarship
8. ADA Culminates Yearlong 150th Anniversary Observance at Its 150th Annual Session
9. ADAs 2009 Gold Medal Award Presentation Set for 150th Annual Session
10. 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
Post Your Comments:
Related Image:
DIA 8th Annual Electronic Submissions Conference Addresses Current Developments in eCTD around the World 
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... products to meet the demand of today’s consumer and regulatory authorities worldwide. From ... probiotic experts and tested to meet the highest standard. , These products ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in ... 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced ... 2017. , The annual award competition recognizes editorial and design excellence across a range ...
(Date:10/12/2017)... Mich. (PRWEB) , ... October 12, 2017 , ... ... has been named one of Michigan’s 2017 Best and Brightest in Wellness® by ... Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... 2017 AVACEN Medical (AVACEN) announced that its ... helping those with the widespread pain associated with fibromyalgia ... in Essex, England commented, "I ... experiencing no sleep at all, tremendous pain, with every ... recommend [the AVACEN 100] enough, how this has and ...
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis , the ... chains, has published the first annual edition of its Global CSR Risk ... 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed nearly ... ... Performance Index ...
Breaking Medicine Technology: