EU Clinical Trial Regulation 2022 – Impact on regulatory, labeling and QP
Synopsis
The EU Clinical Trial Regulation (No 536/2014) was adopted in June 2014 by the European Commission and came into force on 31 January 2022. Navigating the new regulatory changes is vital for successfully progressing complex clinical trials in the EU market and ensuring the timely supply of your Investigational Medicinal Products (IMPs).
Watch this on-demand webinar to hear industry experts Harry Berlanga, Kevin Shea and Lindsey Zweig from Thermo Fisher Scientific discuss impact of the new regulatory changes.
The webinar will start after the introduction of Patheon pharma services’ integrated clinical supply solutions.
Learning points
EU legislative changes under EU GMP and Clinical Trial Regulation
Significant changes to labeling & possible solutions
CTA applications made through a single EMA portal
Impact of Brexit on the adoption of the EU Clinical Trial Regulation in the UK
