Module 6

02/10/2024

EU Regulatory Early Access Tools Stages throughout development

Compassionate Use

PRIME Adaptive Pathways

Post Authorisation

Non-clinical

Phase I

Exploratory

Confirmatory

Evaluation

Discuss opportunities for Accelerated Assessment and Conditional MAA

Accelerated Assessment

MAA under Exceptional Circumstances

• •

Conditional Approval

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

29

EU Regulatory Early Access Tools Benefits patients with unmet medical needs

Compassionate Use

PRIME Scheme

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

30

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