On May 16, the European Medicines Agency (EMA) confirmed that after a long hiatus (punctuated only by COVID-related publications), Policy 0070 will officially resume in September 2023.
What does this mean for clinical trial sponsors?
For the first time, you may have to balance all three regulatory requirements - EMA Policy 0070, EU CTR, and Health Canada’s PRCI.
Join Niamh McGuinness, Senior Advisor, Clinical Trial Transparency and Privacy, to learn more about: