Event Detail
The Role of Investigative Toxicology and Safety Biomarkers in Drug Safety Evaluations
March 4, 2010
- Palo Alto CA UNITED STATES
ComplianceOnline
This training will highlight key toxicity issues that should be followed up through mechanistic/investigative studies, define the current best practices in these key areas and define what the regulatory agencies want to see in terms of mechanistic/investigative follow-up and safety biomarker and the defined regulatory path in terms of data submissions. Why Should You Attend: Nonclinical Drug safety assessment encompass several regulatory mandated areas of evaluation and the study designs and data reporting criteria for these regulatory submissions are fairly well defined, but what happens when a toxicity issue arises and the development decisions are not clear cut? What additional data sets might be needed and how do these mechanistic or investigative data sets get integrated into the regulatory filings and how will they be evaluated by the regulatory agencies. What about safety biomarkers? Should companies jump on this band wagon and what is the current regulatory path-forward for safety biomarker development? This training will look at several toxicity issues that must be addressed in the drug safety assessment, define the current best practices for evaluation of these issues, highlighting the key data sets that regulatory agencies want to see in order to evaluate the overall safety of the drug candidate. An update on the current state of safety biomarker regulatory path will be discussed. Case studies will be used to highlight the path forward evaluations for key toxicity issues that often arise during routine drug safety assessment studies. Areas Covered in the seminar: * Bioassay development that improve interpretation of risk with highlights of new toxicology technologies that may increase the percentage of drug candidates that are successful.. * Define key aspects of Safety Biomarker qualifications and submission process. * Case studies highlighting the benefits of these new technologies in defining the path-forward strategies. * Ensure compliance by understanding the regulatory processes involved in submission of investigative/ mechanistic and safety biomarker data sets and how these data are used in the regulatory approval process.