Module 6

02/10/2024

EU Regulatory Early Access Tools Benefits patients with unmet medical needs

Conditional MA

Accelerated Assessment

Reference: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000856.jsp&mid=WC0b01ac0580b18c78

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

31

Comparison of PRIME vs BTD

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

32

16