US Market Matters for Life Sciences Companies

Overview

Many Life Sciences companies in Northern Ireland have successfully expanded to the U.S. market, and many more are poised to do so in the next several years. These companies must navigate a regulatory pathway to get (and stay) in the market, and understand the basic policies, sometimes unwritten, that drive decision-making at the U.S. Food and Drug Administration (FDA).

Companies also must determine the best method by which to access the U.S. market, minimize tax complications, and insulate the Northern Ireland parent from U.S. liability. Michael Burke and Alan Minsk, Arnall Golden Gregory, LLP will present a workshop on behalf of Invest NI to provide life sciences companies in Northern Ireland with what they need to know now about expanding to the U.S. market. The workshop will cover:

  • Interacting with the FDA;
  • Addressing advertising and promotional concerns for life sciences products;
  • Distance (direct sales, distributors, and agents) expansion versus setting up a U.S. affiliate company;
  • Basic U.S. regulatory compliance strategies for medical devices, pharmaceuticals, cosmetics, healthcare IT, and wellness devices;
  • Tax considerations related to U.S. expansion; and
  • Insulating the Northern Ireland parent from U.S. operational liability and risk.

Programme

TimeActivity
11:45 Registration
12:00 Lunch & networking
12:30 Workshop commences
13:30 Q & A

A limited number of appointments will be available for 1:1 meetings with Mike and Alan for Invest NI customers who have specific queries or are interested in the market. To book an appointment select a time from the dropdown menu when registering.

Speakers

Mike Burke portrait

Mike Burke... is a partner in the Washington, DC office of Arnall Golden Gregory, LLP, and is a past Chair of the American Bar Association’s Section of International Law. He started and manages the blog Irish Export Insights, a resource for Irish and Northern Irish companies looking to expand to the United States. Mike focuses his practice on corporate and commercial matters, including advising non-U.S. businesses on their U.S. expansion; the structuring and execution of mergers and acquisitions; raising venture capital; building and operation of joint ventures and strategic alliances; and creating distribution and reseller networks. He can be reached at Mike.Burke@agg.com..

Alan Minsk portrait

Alan Minsk... is a partner and leader of the Food and Drug Practice Team in the Atlanta and Washington, DC offices of Arnall Golden Gregory, LLP. He is recognized by Chambers USA America's Leading Lawyers for Life Sciences, Regulatory/Compliance and has been selected for inclusion in the International Who’s Who of Life Sciences Lawyers from 2013 - 2017. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the U.S. Food and Drug Administration. He can be reached at Alan.Minsk@agg.com.

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Additional Details

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Invest NI HQ, Bedford Street, Belfast

1 Bedford Square,

Belfast,

United Kingdom

BT2 7ES