Module 1 2021

28/06/2021

 The burden of Post-Approval Life Cycle Management is often underestimated by other R&D functions  In most companies, Regulatory Affairs is in charge to ensure that at any time during the life of a product the right priority can be given.  Imagine a simple safety variation to include a new side effect in the label.. Life Cycle Management: a multi-disciplinary activity

● Analyses done by the safety, epidemiology, statistics… ● Involvement of Labeling, Medical Writing, Regulatory Operations … ● Submit the variation with the new label to the Health Authorities within 60 days after the initial safety signal. ● Ensure implementation in the PI

A pro-active, strategic, forward looking leadership role of Regulatory Affairs is the key to success!

The Organisation for Professionals in Regulatory Affairs

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Complex Life Cycle Management The new reality?

 Earlier submissions, limited data, more post-approval commitments.  With shorter development timelines, the burden of post-approval LCM becomes higher  Especially in the first years of the life cycle, new safety signal will be reported frequently, and new indications are studied in parallel

The Organisation for Professionals in Regulatory Affairs

18

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