Navigation Links
DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing
Date:7/9/2009

August 11-12 in Philadelphia, PA

Horsham, PA (Vocus) -- The Drug Information Association (DIA), in collaboration with the Generic Pharmaceutical Association (GPhA), PhRMA, and the Consumer Healthcare Products Association (CHPA), will host eDrug Listing and Establishment Registration--FDA and Industry: Overview and Lessons Learned on SPL (August 11-12; Philadelphia, PA)

The FDA Amendments Act (FDAAA) mandated the requirements for electronic drug establishment registration and drug product listing. FDA has adopted the use of extensible markup language (XML) files in a standard structured product labeling format as the standard format for the exchange of drug establishment registration and drug product listing information. Featured topics will include:

 
  • Lessons learned from the electronic registration/drug product listing pilot
  • Validation rules applied by FDA
  • Nuances of SPL lifecycle management, including findings from the electronic listing pilot and early production submissions.
  • SPL Release 4 terminology
  • Product listing and establishment registration for various complex scenarios (e.g., export only products, product kits, etc.)
The SPL Vendor Showcase will provides an opportunity for attendees to evaluate a number of currently available services and tools as they are used to produce an equivalent final product. During this session, participating vendors will demonstrate their services and/or tools and present their results.

The SPL Live Q&A will allow attendees to ask key FDA representatives about electronic establishment registration and product listing regulatory content, SPL technical content, or the ESG submission process

"This one-of-kind event is the only opportunity to hear industry and FDA representatives discuss best practices for electronic establishment registration and product listing," says Program Co-chair Therese Brunone, MS, Assistant Director, Global Regulatory Operations, GlaxoSmithKline.

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.

Contact: Joe Krasowski   
215-293-5812

###

Read the full story at http://www.prweb.com/releases/2009/07/prweb2621874.htm.


'/>"/>
Source: PRWeb
Copyright©2009 Vocus, Inc.
All rights reserved  

Related medicine news :

1. The Leukemia & Lymphoma Society Hosts Workshop On Weighing Treatment Options For Chronic Myelogenous Leukemia
2. IOM workshop on less confusing drug labeling, Oct. 12
3. IOM Workshop Calls for Greater Research Focus on Environmental Causes of Autism
4. Educational media workshop unites cancer scientists and journalists
5. TV Personality and Best-Selling Author Jenny McCarthy Comes to Detroit to Share Her Story of the Struggles and Triumphs of Raising Her Son, Evan, During a Day-Long Autism Workshop
6. Wake Forest to host nanomedicine workshop
7. Keynoters, symposia, workshops highlight dental research meeting
8. Anthem Blue Cross Tackles Childhood Obesity in California Through Free BMI Workshops for Pediatric and Family Medicine Health Care Providers
9. 2008 Caregiving Conferences Come to Wayne County, Offering Free Workshops and Resources in Canton and Taylor Locations
10. Pharsight Invited to Present on Antiviral Modeling and Simulation at DIA Adherence Workshop
11. Nationally Acclaimed Author and Local Life Coach Help Local Women Find Their Way to Personal Fulfillment at Free Workshop on Tuesday, May 20
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing
(Date:8/22/2017)... ... ... “Call Of Spiritual Duty”: a revelation in an era defined by intentional ... Growing up on the streets of North Visalia, California, Carlos Lizarde quickly became familiar ... keys to his life, he noticed immediately that opportunities and blessings began to shift ...
(Date:8/21/2017)... ... August 22, 2017 , ... Nanoparticle research provides an exciting ... By learning and implementing best practices for containment using ventilated safety enclosures, many ... gain a better understanding of a method for safely testing nanotechnology hoods. They ...
(Date:8/21/2017)... ... August 21, 2017 , ... FCPX LUT Monochromatic Volume 2 is ... and easily add washed color grades to footage. A LUT is a Lookup Table ... color to the corresponding color indicated by the table. This pack comes with 60 ...
(Date:8/21/2017)... ... August 21, 2017 , ... ... place all over the country. , Outdoor running increases exposure to ultraviolet radiation, ... an increased risk of melanoma, and only half may be adequately protecting themselves ...
(Date:8/21/2017)... New York, NY (PRWEB) , ... August 21, 2017 , ... ... healthcare brands, was recently named one of the Top 100 agencies of the year ... list in MM&M’s annual agency issue, marking an important milestone for the agency. ...
Breaking Medicine News(10 mins):
(Date:8/7/2017)... GAITHERSBURG, Md. , Aug. 7, 2017 /PRNewswire/ ... for healthcare member acquisition, retention, and engagement, announced ... Director of Strategy and Product Development, effective as ... strategic consulting and technology implementation strategy for our ... years of experience in consulting and business analytics ...
(Date:8/4/2017)... , Aug. 4, 2017 The search ... shortly after a physician/patient consult has long been the ... was a notable focus of the largest meeting of ... according to healthcare market research firm Kalorama Information.  The ... testing (POCT) offerings or related supplies and software were ...
(Date:8/2/2017)... 2, 2017  Life Flight Network and PeaceHealth Oregon Network ... patient care and operational efficiency for patients at hospitals in ... Cottage Grove , and Florence, ... and Life Flight Network work collaboratively to move patients who ... when a time sensitive emergency exists. ...
Breaking Medicine Technology: