QP release in the EU in 2022 and beyond: Your questions answered

Webinar On Demand

With the rules on Qualified Person release undergoing significant change, it will be important to discuss and maintain an ongoing understanding of Good Manufacturing Practice (GMP) and new legislation in order to successfully navigate the global clinical trials market and ensure the timely supply of your Investigational Medicinal Products (IMPs).

In Europe, and in the UK, the Qualified Person (QP) plays a crucial role in bringing safe and timely products to the market and/or supplying them to the clinic. There have been interesting regulatory developments in Europe– most notably the EU Clinical Trial Regulation 2022 – and it is critical for pharmaceutical companies to be up to speed with these. The UK has also just issued proposals to overhaul its clinical trial framework.

In this webinar, clinical QP experts answered numerous questions regarding QP release and gave a presentation on:

  • Expectations and responsibilities of the UK and EU QPs
  • New regulatory horizons in the UK, and how to set up a UK QP oversight process
  • The new landscape for Northern Ireland clinical supply
  • Filing for the first time under EU Clinical Trial Regulation 2022
  • Ensuring supply of clinical and commercial drug products between the UK and the EU