Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 1 - Introduction".

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.

Preview image for the video "Chapter 2 - Challenges and Opportunities".

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.

Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 3 - A company perspective".

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. 

Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 4 - Invest NI support".

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.

Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 5 - Questions and Answers".

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