October 2020
RRL Regulatory Tips and Insights

Since the beginning of August 2020, we have published weekly Regulatory tips and insights from our Regulatory experts on our Real Regulatory LinkedIn page, as a service to our followers. The tips we published in November 2020 are collected here, for convenience. Make sure you follow Real Regulatory Ltd and Real CMC for regulatory news, reports and hints.
Clinical Trials: Non-Substantial Amendments
eAF Updates During Procedures
EU Orphan Drug Designation
EMA IRIS: Active Substance and RPI for Orphans