ERT Presents Suicidality in Clinical Trials Educational Workshop with Healthcare Technology Systems
News Aug 17, 2009
ERT has announced its educational pre-conference workshop co-hosted with Healthcare Technology Systems, Inc. (HTS). As part of the Clinical Trials in CNS conference, this workshop entitled "Assessing Suicidality in Clinical Trials and Addressing the Regulatory Directives" will be held at 1:30 pm - 4:30 pm, Tuesday 24th November 2009, in London, UK.
To register for the pre-conference workshop please visit: www.smi-online.co.uk/events/execbrief.asp?is=4&ref=3171&eb=#3344.
The latest FDA Regulatory Directive requires that prospective suicidality should be monitored in every phase II - IV study, in every protocol and at every visit across therapeutic areas. Professionals in the relevant industries have to ensure their monitoring is in compliance with the latest rules.
This workshop is designed to guide Clinical Directors, Therapy Heads, Medical Directors and Clinical Project Managers through the nuances of these new regulations so that they will be better informed and prepared for future trial planning.
In particular, during the workshop, three professionals will present methods to make sure that participants' safety monitoring meets the standards and assessments needed in all clinical studies.
Through the workshop, participants will learn what the directive for prospective suicidality monitoring entails, the latest regulatory updates and what experts have already learned about monitoring patient behavior in this area. In addition, they will have a chance to gain knowledge of how to address these new regulatory requirements and how to evaluate the right approach for trials.
The guest expert speakers include Alan Gelenberg, MD, President and CEO of Healthcare Technology Systems, Inc., , who is a Clinical Professor of Psychiatry at the University of Wisconsin School of Medicine and Public Health and Editor-in-Chief of the Journal of Clinical Psychiatry; Michael Federico, Vice President ePRO Solutions, ERT and Peter Bennett, Product Specialist, ePRO Solutions, ERT.