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EU Clinical Trial Regulation 2022 – Impact on regulatory, labeling and QP

Webinar On Demand

The EU Clinical Trial Regulation (No 536/2014) was adopted in June 2014 by the European Commission¹ and will come 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).

Download this webinar to hear industry experts Harry Berlanga, Kevin Shea and Lindsey Zweig from Thermo Fisher Scientific discuss:

  • 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