Spring Intro 2023

30/03/2023

Who ?

Internal • Regulatory (US, EU and RoW) • Local Regulatory Affiliates • Clinical Research • Project Team (including commercial) • Intellectual Property colleagues • Medical (possibly)

External • EMA

• National Agencies

The Organisation for Professionals in Regulatory Affairs

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Points to remember

PRIME • Important early interaction to consider for products fulfilling major unmet medical need.

Accelerated Assessment • Can your company respond to all assessment questions within 30 days?

Conditional Approval/Exceptional Circumstances • Do not underestimate the resource involved in renewing the licence on an annual basis Adaptive Pathways • Marketing exclusivity considerations – Initial approval in a restricted population Compassionate Use • National programmes – discuss with your affiliate regulatory and medical affairs colleagues

The Organisation for Professionals in Regulatory Affairs

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