![Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 1 - Introduction". Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 1 - Introduction".](/sites/default/files/oembed_thumbnails/D-GJ7c58QkqgqwFm6QataLvdM90tX3hh3WQA8JBomRY.jpg)
Chapter 1 - Introduction by Grainne McVeigh, Director, Life Sciences & Scaling, Invest NI
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". Preview image for the video "Chapter 2 - Challenges and Opportunities".](/sites/default/files/oembed_thumbnails/vjLtqVnDeZ499cjNc6XQV45L9Bnmwh6GhAOJr_u5HLs.jpg)
Chapter 2 - Challenges and Opportunities when Communicating with the U.S. Food and Drug Administration – Alan Minsk, Arnall Golden Gregory LLP
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". Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 3 - A company perspective".](/sites/default/files/oembed_thumbnails/KOuL5hfxUP4xeLsnneurleM4TZMEY77XPtDauafTW2w.jpg)
Chapter 3 - A company perspective – Neurovalens – Dr Jason McKeown, Chief Executive Officer
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". Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 4 - Invest NI support".](/sites/default/files/oembed_thumbnails/4qnf6ZTF_3kUNBFz6o8mXZilF8JvsGv_r2JhyQMXfng.jpg)
Chapter 4 - Invest Northern Ireland support – Matt O’Rourke, Invest NI
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". Preview image for the video "COVID-19 Response - The FDA: Challenges and Opportunities - Chapter 5 - Questions and Answers".](/sites/default/files/oembed_thumbnails/lYax-csvijdGIods4jRV98jAnwElkJ3qVZdefpo3V0s.jpg)
Chapter 5 - Questions and Answers
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.
Chapter List
- Chapter 1 - Introduction by Grainne McVeigh, Director, Life Sciences & Scaling, Invest NI
- Chapter 2 - Challenges and Opportunities when Communicating with the U.S. Food and Drug Administration – Alan Minsk, Arnall Golden Gregory LLP
- Chapter 3 - A company perspective – Neurovalens – Dr Jason McKeown, Chief Executive Officer
- Chapter 4 - Invest Northern Ireland support – Matt O’Rourke, Invest NI
- Chapter 5 - Questions and Answers