Paula Antunes

Company: Novo Nordisk

Job title: Global Regulatory Lead

Seminars:

Panel: How to Overcome the Different Regulatory Requirements to Maximize Your Chance of Successfully Introducing Your Product to the US Market 2:30 pm

Exploring the nuanced differences between US and European regulatory landscapes, understanding their implications on innovation and safety for an informed market entry strategy Uncover actionable insights to harmonise your approach, effectively addressing distinct requirements on both sides of the Atlantic and maximising the potential for successful product introduction Learning how to balance innovation and safety considerations in your product development…Read more

day: Conference Day Two

Between Two Continents: Comparing US and EU Cybersecurity 1:30 pm

Exploring the varying regulatory requirements for SaMD cybersecurity in the US and EU, including a comparison of FDA guidelines and the EU regulation and guidelines Discussing the latest cybersecurity threats facing SaMD, such as data breaches, ransomware attacks, and supply chain risks, and a comparison of how the US and EU are addressing these threats Reviewing technologies and best…Read more

day: Conference Day Two