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.

This audio conference covers:

• FDA requirements for registration and listing, including prescription, API, OTC, drug/cosmetic and homeopathic products
• Useful lessons learned through ESG submissions
• Recently implemented validation rules
• Practical advice for avoiding SPL R4 validation errors
• Discussion of SPL R5 and its implications

About the speaker:

Greg Onyszchuk, PhD, has been involved in the technology and life sciences industries for over 23 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, Quality, Compliance, IT and Manufacturing executives from companies engaged in:

• Manufacturing and distribution of prescription, over-the-counter (OTC) and cosmetic drug products
• Active drug substance manufacturing
• Analytical testing
• Human drug compounding
• Repacking, relabeling, medical gas transfilling