DIA Structured Product Labeling Workshop To Analyze Electronic Drug Establishment Registration And Drug Listing

Main Category: Pharmacy / Pharmacist
Also Included In: Pharma Industry / Biotech Industry;  Conferences
Article Date: 01 Oct 2008 - 10:00 PDT

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The FDA Amendments Act requires electronic drug establishment registration and drug listing. FDA is adopting the use of extensible markup language (XML) files in a standard SPL format as the standard format for the exchange of drug establishment registration and drug listing information. In response, theDrug Information Association (DIA) will host Structured Product Labeling (SPL) Preparing for FDA Electronic Drug Registration and Drug Listing (October 29-30; Philadelphia, PA).

The workshop will feature discussion on:

- Electronic drug establishment registration and listing SPL
- Data Universal Numbering System (D-U-N-S®)
- Electronic Submissions Gateway (ESG)
- SPL reference documents
- SPL lifecycle management
- Listing data elements/Terminology
- Transitioning from paper to electronic
- Animal drugs
- Active Pharmaceutical Ingredients (APIs)
- Brand names
- Biologics
- Generics
- Over-the-counter drugs (OTC)

FDA representatives will answer specific questions and requests for clarification on preparing for electronic drug registration and drug listing in SPL.

Participating vendors will demonstrate their services or tools and present their results to attendees during a unique vendor showcase. You must be a registered exhibitor to participate in this Showcase; for more information, please contact Erin.Gilliland@diahome.org.

About the Drug Information Association (DIA)

DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries 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, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team.

Drug Information Association (DIA)