Module 18 2021

05/02/2021

Challenges

How will NBOp be used?

 Are the CAs looking for information in the NBOp or just that assessment is complete

 Sterilisation- particularly components and re-sterilisation  Shelf life

Responsibility where there is overlap

 Stability/ transport studies, draft SPC  Do Competent Authorities accept the submission of the NBOp during the clock stop?

What to do about incomplete data

 Missing evidence for an GSPR  Negative Opinion  Follow up actions? Recommendations to the CA

What to handle non- fulfilled requirements?

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Key Takeaways

The Combination product area is complex The Device-Drug process is well established but the requirement for reconsultations could be challenging The Article 117 process is new and will evolve Engage with all Stakeholders

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