The Clinical Trial Supply Chain Strategy Meeting East Coast USA 2022 event is taking place on 19 May and we’re delighted to be attending
Beth Halliday is a round table facilitator and will be bringing her expertise to the table at the strategy meeting where she will examine the Effects the Clinical Trial Regulation has Brought to EU Clinical Trials.
The European Union Clinical Trial Regulation 536/2014 (CTR), which is coming into full effect in 2022, will significantly change how companies conduct their trials. In this roundtable, we will discuss the changes, benefits and potential challenges that the Clinical Trial Regulation has brought to EU clinical trials, including:
- The application process and timeline
- The Clinical Trial Information System
- Auxillary medicinal product requirements
- The changes to GMP directives
- Labeling considerations