Latest Past Events

FDA Pre-Determined Change Control Plan (PCCP): Recommendations for Planning Your Strategy and Approach

Webinar

Overview Understand the intricacies of the FDA’s Pre-Determined Change Control Plan (PCCP) and its application across medical devices and in vitro diagnostics (IVDs). This webinar is designed for global regulatory and quality professionals aiming to streamline their strategies for managing post-market device modifications. Attendees will walk away with a deeper understanding of regulatory changes and […]

Devices in Focus: How to Save Time & Money with Real World Evidence (RWE)

Webinar

Real world evidence is increasingly important for companies seeking to demonstrate device performance without the time and expense of extensive clinical trials. This webinar will explore how to effectively use real-world evidence in regulatory submissions to accelerate product approvals and meet post-market surveillance requirements. Learning Objectives: Summarize recent regulatory guidance pertaining to the use of […]

Good Science vs. Bad Writing: Strategies for Building an Effective Scientific Writing Team

Webinar

Writing is not an innate talent, but a learned skill requiring extensive training and practice. Scientific writing is no exception.  As scientists, we have all seen examples of how bad writing and ineffective communication can detract from good science. The goal of this presentation is to describe strategies to support effective partnerships between regulatory experts […]