As medical device manufacturers continue to engage with investigators in external research to support new and existing products, the focus of monitoring these studies has never been more important. Working with investigators from the initial phase of the study and remaining engaged with the study site throughout the duration of the trial in order monitor the progress, to assess the outcomes as well as assist in meeting deadlines is a top priority for every manufacturer. These studies also involve significant investments and often fall out of the scope of a products stated use, because of which there are considerable financial and regulatory parameters that are vital to ensure a compliant IIS program. With many challenges to overcome in order to successfully design, collaborate and execute an investigator initiated study, there is much value in meeting as an industry to discuss best strategies to ensure maximum outcomes.
Building upon the tremendous success of our first two annual meetings, TT Group Worldwide is proud to introduce the 3rd Annual European Medical Device Investigator Initiated Study Meeting. The two-day meeting will cover the entire Investigator Initiated study process in-depth and will help attendees gain insights on the best practices and strategies for deriving the greatest possible value from these research programs.
This meeting will also focus on the key changes in ISO 14155:2019 and will also discuss the new European MDR where attendees will have the opportunity to engage in a direct dialogue with Notified Body representatives to understand the regulatory requirements to ensure compliance. Through highly interactive presentations, case studies, roundtable discussions and panel debates, attendees will be able to build a well-rounded plan to improve their IIS initiatives.