Chapter 1 - Introduction by Grainne McVeigh, Director, Life Sciences & Scaling, Invest NI

2 minutes

Video Overview

The coronavirus pandemic is causing unprecedented changes in every industry. This webinar will look at the opportunities available for Life & Health Science companies within the US market.

Chapter 2 - Challenges and Opportunities when Communicating with the U.S. Food and Drug Administration – Alan Minsk, Arnall Golden Gregory LLP

44 minutes

Video Overview

This chapter provides insight into regulatory oversight and common mistakes when working with FDA and how to avoid them.

Chapter 3 - A company perspective – Neurovalens – Dr Jason McKeown, Chief Executive Officer

22 minutes

Video Overview

Dr Jason McKeown CEO of Neurovalens provides a Northern Ireland company perspective of the FDA and their experience of dealing with FDA registration. 

Chapter 4 - Invest Northern Ireland support – Matt O’Rourke, Invest NI

10 minutes

Video Overview

In this chapter we look at the in-market support mechanisms and assistance available from Invest Northern Ireland.

Chapter 5 - Questions and Answers

17 minutes

Video Overview

This chapter answers the frequently asked questions on entering the US market and managing the FDA.

The FDA: Challenges and Opportunities

In all global Life & Health Science markets, regulatory compliance is an essential part of a company’s market entry strategy into a new geography. This tutorial will help Northern Ireland companies who want to enter the US market better understand the US Food & Drug Administration (FDA), its requirements and how to successfully manage getting products through FDA registration.

95 minutes
5 videos