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

Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions

As of June 1, 2009, the FDA requires establishment registration and drug-listing data in a fully electronic format known as structured product labeling (SPL). This guidance applies to all prescription pharmaceutical, biological, OTC, and veterinary medicine producers and distributors. The implementation of SPL will eliminate the creation of paper forms, which duplicated information already contained in product labeling.

As industry continues to provide more electronic labeling information, the FDA is able to decrease the amount of proofreading of paper submissions, thereby decreasing the chances of human error. This audio conference explores how SPL allows for electronic technology to capture this information, decreasing the potential for human error in transcription and increasing efficiencies.

Using SPL for Electronic Drug Establishment Registration & Drug Listing Submissions is being presented by Craig Trautman, CEO, with Intagras and airs on Tuesday, July 14, 2009. For more details or to register for this conference, please visit our site at www.fxconferences.com

SPL & Beyond: XML in the Life Sciences

As Structured Product Labeling (SPL) continues to evolve and become adopted throughout the FDA, organizations must ensure their original approach to SPL compliance is the best strategic fit for the enterprise. Initially, the goal for most organizations was focused solely on implementing systems and/or processes to achieve SPL compliance. Depending on your approach, SPL compliance can either result in additional time and cost to the overall submission process, or provide long-term value across the enterprise.

With additional XML-based standards under development, and the ability for structured content to drive efficiencies throughout an enterprise, it is prudent to review your overall approach to structured content authoring and publishing. This presentation looks at how XML can be used to manage content for SPL submissions to the FDA, Product Information Management (PIM) submissions to EMEA, as well as other uses such as standard response letters for customer contact centers.

SPL & Beyond: XML in the Life Sciences was presented by Don Bridges & Joe Jenkins, Commercial Technical Documents Manager, Data Conversion Laboratory (DCL) & Life Sciences Market Director, RWD Technologies and aired on 2006-04-06. For more details, or to download this conference, please visit our site at www.fxconferences.com

SPL & Beyond: XML in the Life Sciences

As Structured Product Labeling (SPL) continues to evolve and become adopted throughout the FDA, organizations must ensure their original approach to SPL compliance is the best strategic fit for the enterprise. Initially, the goal for most organizations was focused solely on implementing systems and/or processes to achieve SPL compliance. Depending on your approach, SPL compliance can either result in additional time and cost to the overall submission process, or provide long-term value across the enterprise.

With additional XML-based standards under development, and the ability for structured content to drive efficiencies throughout an enterprise, it is prudent to review your overall approach to structured content authoring and publishing. This presentation will look at how XML can be used to manage content for SPL submissions to the FDA, Product Information Management (PIM) submissions to EMEA, as well as other uses such as standard response letters for customer contact centers.

This audio conference is co-presented by Don Bridges of Data Conversion Laboratory and Joe Jenkins of RWD Technologies. To learn more, visit www.fxconferences.com.