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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Begin with the end in mind….

 … to ensure that the development of a new product addresses the future regulatory requirements for approval and will lead to a product that meets the patients needs.

 But what is the end? ● The successful approval of the product?

● The reimbursement, launch and the availability for patients? ● Or…. is that just the beginning of the life cycle of a product?

 During development R&D fully focusses on the initial approval ● most of the R&D teams (including RA) switch immediately to other projects.

The Organisation for Professionals in Regulatory Affairs

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