Title:
eDrug Listing and Establishment Registration FDA and Industry: Overview and Lessons Learned on SPL
Date(s) And Time(s):
Aug 11 2009 8:00AM - Aug 12 2009 5:00PM
Location:
The Westin Philadelphia
99 South 17th Street
Philadelphia, PA 19103
Overview:
Your Only Opportunity to Hear Industry and FDA Discuss
Best Practices for Electronic Establishment Registration and
Product Listing.
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
· 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 of various and complex scenarios (e.g., export only products, product kits, etc.)
· Much more!
Learning Objectives:
LEARNING OBJECTIVES – DAY ONE – AUGUST 11
At the conclusion of this meeting, participants should be able to:
· Identify information to be included in electronic drug establishment registration and drug product listing submissions and understand validation rules applied by FDA.
· Explain SPL Release 4 terminology and process
LEARNING OBJECTIVES – DAY TWO – AUGUST 12
At the conclusion of this meeting, participants should be able to:
· Discuss findings from the electronic listing pilot and early production submissions
· Discuss nuances of SPL lifecycle management
Target Audience:
TARGET AUDIENCE This program will benefit individuals involved in:
|
INDUSTRY
· Pharmaceuticals
o Brand
o Generics
o Over-the-counter drugs
· Biotechnology
· Vaccines
· Active pharmaceutical suppliers
· Veterinary medicine
|
JOB FUNCTION
· Regulatory Affairs
· Research & development/Strategic issues
· Manufacturing: drug substance, drug product, packaging
· Document management
· Information management
· Information technology
· Dictionaries/Data standards
|
Event Code:
09015
Contact Information:
Event information: Contact Ben Zaitz at the DIA office by telephone +1-215-293-5803, fax +1-215-442-6199 or email Benjamin.Zaitz@diahome.org.
Tabletop exhibit information: Contact Jeff Korn, Exhibits Associate, at the DIA office by telephone +1-215-442-6184, fax +1-215-442-6199 or email Jeff.Korn@diahome.org.