What Would You Do? Regulatory Staff Consider Some Tough Tests
Executive Summary
Delegates and experts were faced with some difficult choices during a session at this year's TOPRA annual symposium.
You may also be interested in...
How To Avoid Regulatory Mistakes: Experts Put To The Test
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.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.