On September 6th Stockholm Science City together with Business Sweden will arrange a breakfast seminar on market access and FDA approval in the U.S. The U.S. represents the single largest market opportunity for life science, medtech and digital health companies, and its also known for its fierce competition. Having the right strategy and roadmap is key for success in the U.S., especially in reducing risk.
Under the Trump administration, significant changes have taken place at the FDA which will impact companies that are seeking approval to sell on the market. Understanding the approval processes and relevant changes is crucial for any Swedish company looking to sell in the U.S. in order to prevent costly delays.
When: September 6th, 08:30 - 09:30 (breakfast from 08:00)Where: Wenner-Gren Center, Sveavägen 166, floor 23
Program
- 8:00 Breakfast and networking
- 8:30 The life science journey in the U.S. - a roadmap to entering and growing in the U.S. for life science, biotech and pharma companies. Shaun Hundle, Business Sweden USA
- 9:00 Strategies for success: The FDA in 2018 - an update and guide to navigating the FDA as a life science, medtech or digital health company. Carrie Hetrick, Hetrick Medical Device and FDA Consulting
This seminar will be held in English.
The registration is now closed, please contact anna.frejd@ssci.se if you would like to participate.
During the seminar we will distribute attendance lists with name and organization.