Epstein Becker Green (EBG) hosts “Advanced Topics in Clinical Research,” led by EBG attorneys Elizabeth Scarola and Kate Gallin Heffernan.
This meeting will inform attorneys who represent research sites of current hot topics in the space, covering both research-related internal noncompliance investigations and government enforcement, as well as advanced issues that arise in clinical research negotiations. The meeting will be broken into two sessions.
The first session will provide an overview of legal standards for various research compliance matters, including noncompliance in human subjects research, research misconduct, misuse of federal research grant funds, conflicts of interest, and undue foreign influence. EBG will offer practical guidance related to internal reviews and noncompliance investigations and provide an overview of best practices for managing the logistics of multifaceted research compliance matters.
The second session will focus on advanced negotiations in clinical trial agreement negotiations. While parties engaged in clinical research share a common interest in conducting a successful study, their respective legal requirements and dissimilar perspectives often introduce obstacles to the negotiations. These differing responsibilities and perspectives, coupled with an increase in regulatory scrutiny of clinical trials in recent years, make it important for lawyers who review and negotiate clinical trial agreements to have an informed understanding of the various issues in this area and how to overcome them.
If you have any questions, or are interested in learning more, please reach out to Juliana Passos Figueiredo.