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.
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.
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.
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.
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