Spring Intro 2023

30/03/2023

Where ?

Key activity US and EU (and global markets) – often there is a strong desire for global tradename • EU submission to Name Review Group (NRG) • US submission to FDA

Top tip: Often parallel submissions with different outcomes which leads to multiple rounds of submissions in both EU and US to obtain single name

Tradename can end up on “critical path” to launch

The Organisation for Professionals in Regulatory Affairs

85

Who ?

Internal • Regulatory (US, EU and RoW)

• Commercial • Project Lead • Intellectual Property + Trademarks • Senior leadership

Top Tip: Tradenames are often kept very confidential so always limit core team wherever possible

External • Global activity but in EU external partnership is with NRG

The Organisation for Professionals in Regulatory Affairs

86