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Conference Directory
The Role of Investigative Toxicology and Safety Biomarkers in Drug Safety Evaluations
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Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Project managers,Project team members from preclinical and clinical development,Management team members,Regulatory affairs,Drug Safety,Registration and data management
Start Date of Conference:: 02-25-2010
End Date of Conference: 02-25-2010
Description of Conference: 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.
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.
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