mindsON RBQM | Special Edition – New FDA Guidance on RBM: What is it and what does it mean?
The FDA has just published a “Guidance for Industry” – a Question and Answer guide to supplement the 2013 Guidance “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.” The 2013 Guidance sent shockwaves through the industry. It led, with other regulators, to the 2016 addendum to ICH E6, including a risk-based approach to monitoring and introducing the concept of centralized monitoring. So what is this new Guidance? And what are the implications? We’ll take you through the document and our interpretation, and there will be opportunities for attendees to provide their perspectives and for us to learn together.