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.

This audio conference covers:

• Basic steps to establish an ESG account
• Useful lessons learned through ESG submissions
• SPL-R4 file contents
• Implications of the May 29, 2009 Guidance for Drug Registrations and Listings
• An overview of submissions and validation

About the speaker:

Greg Onyszchuk, PhD, has been involved in the technology and life sciences industries for over twenty-three years. At Beckloff Associates, Inc. (BAI), Dr. Onyszchuk is the business leader for the regulatory publishing unit, guiding the business growth, expansion of service offerings and the strengthening of the team and publishing platform. He has championed the implementation of an ESG account at BAI and its use for regulatory submissions, and is a strong advocate for the electronic Common Technical Document (eCTD), the FDA’s Electronic Submissions Gateway (ESG) and electronic drug establishment registration and drug listing.

Dr. Onyszchuk received his doctorate in physiology and neuroscience from the University of Kansas School of Medicine, his master's degree from the University of Quebec at Montreal and his bachelor's degree from McGill University. His scientific training is in neurodegeneration, brain injury and brain imaging.

Who should attend?

• Regulatory Affairs Managers
• Medical & Scientific Writers
• Document Management/Publishers
• Quality Reviewers
• IS/IT Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.