In September 2014, I started a series of webinars directed at Irish and Northern Irish businesses that were doing–or were planning to do–business in the US. This page collects the content from those webinars, and related webinars, with the purpose of providing additional information to Irish and Northern Irish businesses.
Accessing the U.S. Market. This was the first webinar in the series, and introduced the concept of “smart exporting.” With practical advance planning and understanding of potential risk points, the operational risk of exporting/expanding to the U.S. can be controlled and mitigated. Such planning is called “smart exporting.” Exporting grows revenue and profit, but smart exporting can help your company perform even better. The presentation for this ‘smart exporting’ webinar can be found here; the recording of the webinar (requires registration) can be found here.
Distribution Agreements. Distribution and reseller arrangements are a common method for accessing the US market, but present some challenges for Irish and Northern Irish companies. The presentation covers general distribution/reseller issues, including (i) whether, and what kind of, exclusivity arrangements are effective market access points; (ii) protecting intellectual property; (iii) controlling the actions of the distributor or reseller but not triggering US jurisdiction on the parent; (iv) termination issues; and (v) effective dispute resolution mechanisms. The presentation for this distribution webinar can be found here; he recording of the webinar (requires registration) can be found here.
Working with the FDA. Many Irish and Northern Irish companies must interact with the U.S. Food and Drug Administration (FDA) in order to introduce or keep their products in the U.S. Navigating this regulatory pathway requires not only an understanding and appreciation of applicable statutory and regulatory requirements, but knowledge of basic policies, sometimes unwritten, that drive decision-making at the FDA. The presentation provides best practices in dealing with the FDA in key areas, such as: (i) product development and marketing authorization strategies; (ii) product safety and effectiveness standards; (iii) product quality assurance; (iv) product advertising and promotion controls; and (v) post-market surveillance. The presentation for the FDA webinar can be found here.