How To Avoid Regulatory Mistakes: Experts Put To The Test

 
• By Ian Schofield

Target product profiles, database locks, infarct size as a surrogate endpoint, and changes in the manufacturing process featured in a session of this year’s TOPRA Symposium on dealing with tricky regulatory questions.

Confident guy in front of many doors different colored has to choose one. Difficult decision, important choice concept, failure or success.
Regulatory decisions are often far from straightforward • Source: Alamy

This year’s symposium of The Organisation for Professionals in Regulatory Affairs (TOPRA) featured an interesting session where delegates and experts were asked how they would behave in a set of difficult regulatory scenarios.

The Pink Sheet’s first article on the regulatory scenarios session examined issues such as using surrogate outcomes for US breakthrough...

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