Electronic Drug Establishment Registrations and Drug Listings – One Year Later

is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Wednesday, October 6th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

New FDA requirements for electronic drug establishment registrations and drug listings took effect June 1, 2009. Many firms were initially surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. The challenges continue, as new validation rules are implemented, and as scrutiny of file content increases.

To make successful submissions, firms must not only have a technology solution in place (ESG account and SPL R4 file preparation and editing software), they must have a comprehensive understanding of file content requirements, of typical validation errors and how to avoid or overcome them. All of this may be accomplished through internal efforts or with help from a service provider.

This audio conference provides an overview of the current FDA requirements for drug registration and listing, and shares valuable insight gained over the past year.

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway

The new FDA requirements cover both the format (SPL Release 4 files) and the submission modality (via the FDA Electronic Submissions Gateway – ESG) for electronic drug establishment registrations and drug listings, imposing a double electronic challenge upon all firms who must register and list. As of June 1, 2009, paper forms FDA 2656 and FDA 2657 are no longer acceptable. Many firms have been surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. Headaches and frustrations with the tools, the process and the content are increasing as the end of 2009 approaches.

To meet an end-of-year deadline, firms must have a solution for ESG connectivity in place, as well as a means to prepare and validate their SPL R4 files. Most importantly, they must have a solid grasp of the content necessary to produce compliant drug registrations and listings. In this session, the speaker provides practical advice regarding SPL-R4 file content, submissions and validation.

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Thursday, October 22, 2009. For more information about this audio conference, or to register please visit our site at www.fxconferences.com