Module 1 2021

28/06/2021

Learning Outcomes

 Post-approval life cycle management is often underestimated during the development phase  With more and more early submissions based on limited data, post-approval life cycle management becomes a much more critical and high-burden activity  Life cycle management is a multi-disciplinary activity. Once a product is on the market, it is a challenge to get the right priority of all disciplines involved.  Regulatory Affairs is uniquely positioned to manage the life cycle management and to make sure that already in the pre-approval phase the post-approval requirements are sufficiently made clear.

Begin with the end in mind, but be aware that the end of development is only the beginning of the product-life

The Organisation for Professionals in Regulatory Affairs

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Thank you!

Sjaak Bot sbot@its.jnj.com

The Organisation for Professionals in Regulatory Affairs

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